Innovations in Pain Management for Abdominoplasty Patients: A Systematic Review
Abstract
:1. Introduction
2. Materials and Methods
2.1. Literature Search
2.2. Study Selection
2.3. Data Extraction
2.4. Bias Assessment
2.5. Comparing Studies with Patients Who Underwent Rectus Plication and Diastasis Correction vs. Those Without
2.6. GRADE Assessment of All Included Studies
3. Results
3.1. Literature Findings
3.2. Study Characteristics
3.3. Risk of Bias Assessments
3.4. Studies Investigating Nerve Blocks in Patients Who Underwent Rectus Plication
3.5. Studies Investigating Nerve Blocks in Patients Without Rectus Plication
3.6. Studies Investigating Pain Pumps Using Local Anesthetics in Patients Who Underwent Rectus Plication
3.7. Studies Investigating Pain Pumps Using Local Anesthetics in Patients Without Rectus Plication
3.8. Studies Investigating Local Anesthetics Postoperatively in Patients Who Underwent Rectus Plication
3.9. Studies Investigating Local Anesthetics Postoperatively in Patients Without Rectus Plication
3.10. Studies Investigating Opioids in Patients Who Underwent Rectus Plication
3.11. Ketamine
3.12. NSAIDs
3.13. Anesthesia
3.14. Opioids vs. NSAIDs
3.15. Use of Adjuncts
3.16. Results of the Bias Assessment
3.17. GRADE Assessment
Article | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Overall |
Beaton et al., 2023 [11] | Low: Randomized, double-blind, placebo-controlled design with proper randomization, blinding, and allocation concealment. Minimal risk of bias from study design and execution. | Low: There is no indication of inconsistency. Outcomes are measured systematically using standardized scales (e.g., NPRS) at predefined time points. | Low: The study directly addresses the population, intervention, and outcomes relevant to postsurgical pain in abdominoplasty. | Moderate: While the sample size is well-powered for the primary endpoint (SPI24), the lower power for SPI48 (66%) raises slight concerns about precision for secondary outcomes. | Low: The study was registered on ClinicalTrials.gov, and the design reduces the likelihood of publication bias. | High Quality The study exhibits a low risk of bias, direct applicability to the research question, and strong consistency in methodology. While there is some imprecision for the secondary outcomes, this is not sufficient to downgrade the overall quality, resulting in a high-quality rating. |
Abo-Zeid et al., 2018 [12] | Low: Prospective, double-blinded, and randomized design reduces bias, but the randomization is via a closed envelope method. Minimal risk of bias from study design and execution. | Low: No evidence of unexplained variability between groups or within study outcomes, as appropriate statistical tests (ANOVA, Kruskal–Wallis) were used for analysis. | Low: The study directly addresses the population of interest (patients undergoing abdominoplasty) and interventions (TAP-B, RSB, and SCI) relevant to the research question. | Low: Sample size is adequately powered for primary outcomes, and the statistical methodology is sound, giving confidence in the precision of the results. | Low: Registered trial with an IRB approval and clinical trial registration (NCT03077581) reduces the likelihood of publication bias. | High Quality The study has a strong design and execution with low risk in most domains. |
Edwards et al., 2015 [13] | Moderate: This is an observational study, which inherently has a higher risk of bias compared to randomized trials. Although the study followed Good Clinical Practice guidelines and had IRB approval, there is no control group. | Low: The study seems to have consistent methodology across multiple sites with similar treatments and data collection methods, reducing inconsistency risks. | Low: The study directly addresses the relevant population (patients undergoing breast and/or abdominoplasty surgeries) and the intervention (liposome bupivacaine), making it applicable to the research question. | Moderate: Some imprecision arises from the observational design, which limits the ability to draw causal inferences. However, the study appears to include a reasonable sample size and appropriate outcome measures. | Low: A multicenter study with adherence to Good Clinical Practice and detailed outcome reporting reduces the likelihood of publication bias. | Moderate Quality The observational nature and lack of a control group introduces some bias, but the study is well conducted and follows rigorous standards, making it a moderate-quality study. |
Gardner et al., 2019 [14] | Moderate: The study is randomized, which reduces bias; however, there is no mention of blinding, which could affect the results and reporting of pain and narcotic consumption. | Low: The results appear consistent within the study; statistical significance is noted between the two groups for both time points, suggesting reliable outcomes. | Low: The study directly addresses the population undergoing abdominoplasty and the specific intervention (TAP-B), making it relevant to the research question. | Moderate: While statistically significant differences were found, the sample size (20 participants) is small, which may limit the generalizability of the results. | Low: The study presents clear data, and its design as a prospective comparative study reduces concerns about publication bias. | Moderate Quality The randomized design supports quality, but the lack of blinding and small sample size introduces limitations. The significant findings still suggest valuable insights. |
Fiala 2015 [15] | Moderate: The study design includes random assignment of patients to either the TAP block or standard treatment, but there is no mention of blinding, which may introduce bias in pain reporting. | Low: The results are consistent across both groups, with statistically significant differences noted in narcotic use and time to first request for pain medication. | Low: The study directly addresses patients undergoing abdominoplasty and evaluates a specific intervention (TAP block) relevant to post-surgical pain management. | Moderate: While the sample size (32 patients) is reasonable for a pilot study, the findings, though statistically significant, should be interpreted cautiously due to this size. | Low: The study presents clear and relevant data, with a focus on a specific clinical question, reducing concerns about publication bias. | Moderate Quality The pilot study design shows potential efficacy of the TAP block but is limited by the lack of blinding and relatively small sample size, which could affect reliability. |
Minkowitz et al., 2020 [6] | Low: The study is a multicenter, randomized, double-blind trial, which minimizes bias and enhances the reliability of the findings. | Low: The study design is consistent in methodology across multiple centers, and the results are expected to be reliable due to the controlled design. | Low: The study directly addresses the population of interest (patients undergoing abdominoplasty) and compares relevant treatment options (IV tramadol vs. morphine vs. placebo). | Moderate: While the planned sample size of 360 patients enhances power, the actual results may vary, and the specific outcomes need to be interpreted with caution until completed. | Low: The study’s registration and adherence to ethical guidelines reduce concerns about publication bias, ensuring transparency and accountability. | High Quality The phase 3 design, randomization, blinding, and multicenter approach strengthen the overall quality of evidence. The study aims to evaluate both efficacy and safety comprehensively. |
Morales Jr et al., 2013 [16] | Moderate: The study is retrospective and relies on case record reviews, which introduces potential biases in data collection and reporting. | Low: The use of standardized methods for administering liposomal bupivacaine and consistent evaluation criteria across patients helps maintain consistency in the results. | Low: The study directly investigates the efficacy of liposomal bupivacaine in postoperative pain management for patients undergoing abdominoplasty, aligning with the objective. | Moderate: While average pain scores and medication usage provide some insight, variability in individual responses may limit the robustness of findings, requiring further validation. | Low: The findings are likely to contribute valuable information to the existing literature on postoperative pain management, indicating a low risk of publication bias. | Moderate Quality The study provides important data on the effectiveness of liposomal bupivacaine for pain management, but the retrospective nature and small sample size limit its overall quality. |
Price et al., 2023 [7] | Moderate: Although the study has institutional review board approval and includes a clear inclusion criterion, it is retrospective and may have biases in data collection and patient selection. | Low: The study employs standardized protocols for pain management across both groups, contributing to consistent outcomes. | Low: The study directly addresses the impact of a multimodal approach to pain management in abdominoplasty patients, aligning with the stated objective. | Moderate: The sample size of 80 patients is adequate, but potential variability in responses to pain management protocols may affect the precision of the findings. | Low: The study’s findings are likely to fill a gap in literature regarding multimodal pain management in surgical settings, indicating a low risk of publication bias. | Moderate Quality The study contributes valuable insights into multimodal pain management in abdominoplasty; however, the retrospective nature and potential biases in data collection limit its overall quality. |
Mentz et al., 2005 [17] | Moderate: The study employs a randomized design, which reduces bias, but with a small sample size (20 patients), there may still be concerns regarding the potential selection and reporting bias. | Low: The intervention and control groups were clearly defined, with a consistent method of pain assessment and a standardized protocol for administering treatments. | Low: The study directly investigates the use of a Stryker Pain Pump versus standard pain management, addressing the research question without any indirect measures. | High: With only 20 patients, the sample size is small, increasing the likelihood of variability in results and decreasing statistical power, contributing to imprecision. | Low: Given the novelty of the use of a Stryker Pain Pump in postoperative pain management for abdominoplasty, there is no clear indication of publication bias. | Moderate Quality The study presents an innovative approach to pain management with well-documented methodology, but the small sample size and potential biases limit the overall confidence in the results. |
Singla et al., 2018 [18] | Low: This is a randomized, double-blind, placebo-controlled, multicenter trial with well-defined protocols, reducing the likelihood of selection and performance bias. Adherence to Good Clinical Practices further minimizes bias. | Low: The study uses a standardized surgical procedure and pain assessment method across multiple clinical sites, with consistent endpoints, reducing potential inconsistency in outcomes. | Low: The study directly investigates the effect of IV meloxicam on postoperative pain control, addressing the research question without indirect or surrogate measures. | Moderate: The sample size is powered at >80%, which is strong, but the assumption of an effect size of 0.40 may affect generalizability to broader populations. Exact patient numbers are not provided, affecting the precision. | Low: As a phase 3 trial for a well-established drug (meloxicam), there is low risk of publication bias. The trial follows standardized protocols, decreasing selective reporting risks. | High Quality The study design is robust with a clear methodology, randomization, double-blind structure, and appropriate statistical analyses, providing high confidence in the reliability of the results. |
Bjelland et al., 2019 [19] | Low: The study is a triple-blinded RCT with randomization conducted using a concealed computerized block algorithm, reducing bias. Blinding was maintained for patients, personnel, and analysts. However, a single surgeon performed the procedures, which could introduce performance bias, though steps were taken to standardize techniques. | Low: There is no mention of significant variability in the outcomes. Pain and opioid consumption were measured at multiple time points, and consistent methods of assessment (NRS, PCA, etc.) were used across the study. Variability in results was controlled through the use of well-defined protocols and statistical methods, but no external replication was reported. | Moderate: The population (post-bariatric patients undergoing abdominoplasty) and interventions (ropivacaine vs placebo for pain control) are highly specific to this clinical setting. While generalizable within this context, broader applicability to other populations or procedures may be limited. | Moderate: The sample size of 50 patients was relatively small, though justified by power analysis. While confidence intervals were reported, the relatively small sample may limit the precision of the results, especially in detecting smaller effect sizes. However, a sample size of 23 per group was calculated to be sufficient to detect clinically relevant differences. | Low: There is no indication of selective outcome reporting. The study was pre-registered with EudraCT and clinicaltrials.gov, minimizing the risk of publication bias. However, the absence of multiple independent studies reduces the ability to fully assess publication bias. | Moderate Quality The evidence quality is strong due to the robust design (RCT), triple blinding, and use of appropriate statistical analyses. Some limitations exist, such as small sample size and indirectness to broader populations, but the study was conducted with high methodological rigor. |
Ali et al., 2020 [20] | Low: The study was randomized with a computer-generated number table. Treatment allocation was concealed. Double-blinded design, with patients and the anesthetist recording the data blinded to group assignment. Adequate blinding of data collectors and outcome assessors. | Low: No conflicting or heterogeneous results across groups were reported. The study used standard statistical methods (unpaired t-test, Chi-square) without notable variability in outcomes. | Moderate: The study population is relatively specific (ASA I and II, ages 18–50, undergoing elective abdominoplasty), which may limit the applicability to other populations or surgeries. The interventions (ketamine vs. morphine) are widely used in clinical practice. | Low: Power analysis was appropriately conducted, requiring 71 patients per group to achieve sufficient power. A total of 160 patients were enrolled to account for dropouts. Statistical analysis methods were adequately applied with sufficient patient numbers. | Low: The study was registered (NCT03664622), followed transparent procedures, and reported conventional outcomes for pain management trials. | High Quality |
Giordano et al., 2020 [21] | High: As a retrospective study with no randomization, there is a higher risk of bias. The reliance on existing records and potential unmeasured confounders also increases bias. | Low: The results were consistent across groups, with clear differences in opioid use and LOS, and similar complication rates. No notable variability was observed. | Moderate: The population and interventions are relevant, but the small sample size and single-center design limit the generalizability to broader populations. | Moderate: Despite significant findings, the small sample size and wide standard deviations introduce imprecision, reducing the reliability of the results. | Low: There is no strong evidence of publication bias, as both significant and non-significant outcomes were reported. | Low Quality This is due to the retrospective design and imprecision from the small sample size. However, the results are consistent and directly relevant to the study population. |
Shauly et al., 2022 [22] | High: The study is retrospective with no control group or randomization, increasing the likelihood of bias, particularly selection and reporting bias. Additionally, all surgeries were performed by a single surgeon, which could introduce performance bias. | Moderate: There is no clear mention of results variability or heterogeneity across patients, but the uniform protocol may reduce variability, indicating consistent outcomes. However, without comparative data, it is difficult to fully assess this. | Moderate: The study population and interventions are relevant, but the highly specific surgical protocol and single-surgeon setting limit the generalizability to other contexts or surgeons. | Moderate: The relatively small sample size of 80 patients and reliance on subjective pain scores without long-term follow-up data introduce imprecision in the estimates of effectiveness and safety outcomes. | Low: There is no evidence of selective reporting, but the retrospective design and inclusion of a single surgeon’s patients may raise concerns about unpublished negative outcomes. | Low Quality This is due to the retrospective, non-randomized design and moderate imprecision due to the small sample size and subjective outcome measures. While the outcomes are directly relevant, the highly specific surgical setting and protocol further reduce the generalizability of the findings. |
Varas et al., 2020 [23] | Moderate: The study was randomized and double-blind, reducing selection and performance bias. However, the abandonment of the primary outcome after recruiting 25 patients raises concerns about reporting bias. | Low: The methods for randomization and blinding were clearly outlined, and the interventions were well-defined, suggesting consistency. Additional analyses using both linear and nonlinear models further support robustness. | Low: The study’s population (adults undergoing abdominoplasty/liposuction) and interventions (ketamine and magnesium) are relevant to clinical practice, limiting indirectness. | Moderate: While a sample size calculation was performed, the outcome of interest was changed midway through the trial, which may lead to uncertainties in the findings related to morphine consumption. | High: The study adhered to ethical guidelines and Good Clinical Practice. It was registered, ensuring transparency. The careful monitoring of adverse effects adds to the overall quality. | Low Quality The randomized and double-blind design strengthens the study but concerns regarding the changes in the primary outcome and potential biases affect the overall confidence in the results. |
Silva Filho et al., 2021 [24] | Moderate: The results indicate that the trial followed the CONSORT guidelines, which helps to ensure transparency in reporting participant flow. However, there were some missing blood concentration measurements due to sample mishandling, reducing the completeness of the dataset. | Low: The study involves a single population with consistent methodology, inconsistency is unlikely | Low: The findings for systolic blood pressure and secondary outcomes, such as fentanyl and ephedrine consumption, are consistent and follow logical trends between the two groups | Moderate: There are some concerns regarding the precision of certain results. For instance, the study’s statistical significance was noted in certain comparisons (e.g., systolic blood pressure over time) with moderate effect sizes. However, the confidence intervals, especially for blood pressure post-intubation, were relatively wide. | Low: There is no strong indication of publication bias based on the available data. The study appears to have been designed and reported transparently, without selective reporting of outcomes that would raise concerns of bias. | Moderate Quality The evidence is reliable, though there are some concerns about sample size and imprecision in certain measures. However, the results appear consistent and relevant, providing useful insights into the effects of remifentanil and magnesium sulfate. |
Bray Jr et al., 2007 [25] | High: The study is retrospective in nature, which inherently carries a risk of bias due to non-randomized group allocation. This can introduce selection bias, as patients may have been chosen based on factors not controlled for. Additionally, there was no blinding of patients or assessors, which could influence outcomes like pain reporting. | Low: The outcomes showed small, non-statistically significant differences in all key measures, including pain medication use, pain scores, and hospital stay length. The direction of these small differences was consistent, suggesting that there is little unexplained variability between study results. | Low: The population (abdominoplasty patients) and interventions (use of pain pumps) are directly relevant to the clinical question. There is no indirectness in terms of population, intervention, or outcomes that would limit the applicability of the results to similar clinical settings. | Serious: The results did not achieve statistical significance for any outcomes, which limits the precision of the effect estimates. Additionally, the relatively small sample size (38 with pain pumps and 35 without) means that the study may not have had enough power to detect clinically meaningful differences. | Moderate: As this is a single study, the risk of bias cannot be completely ruled out without evidence from other similar studies. | Low Quality While the study addresses a relevant clinical question, the retrospective design, lack of blinding, and imprecision of results reduce confidence in the findings. The evidence provided is of low quality, meaning that further research is likely to impact the confidence in the estimate of effect and may change the findings. |
Chavez-Abraham et al., 2011 [10] | Serious: This was a consecutive case series comparing patients before and after the use of an elastomeric continuous infusion pump (ECIP), without randomization. Lack of randomization and blinding raises the risk of bias, as the study groups were historical controls rather than being directly randomized. Postoperative pain and narcotic use are subjective, and the absence of blinding could lead to bias in reporting. | Moderate: The study does not report significant variability across the different outcomes (pain scores and narcotic use), but without detailed statistical analysis, it is unclear whether the results are consistent across various subgroups or across different outcome measures. As the data are observational, some inconsistency could arise. | Low: The population (augmentation mammaplasty and abdominoplasty patients) and the intervention (ECIP with lidocaine) are directly applicable to the research question on postoperative pain management in plastic surgery. The outcomes of interest (pain scores and narcotic use) are also clinically relevant. | Moderate: The study involves a large number of patients (675 augmentation mammaplasty patients and 200 abdominoplasty patients in the control group; 690 and 215 in the intervention group). However, the results for pain scores and narcotic use are not reported with enough detail (e.g., confidence intervals or p-values) to fully assess precision. Given the large sample size, imprecision is likely not a significant concern. | Moderate: The study does not directly provide evidence of publication bias, but publication bias could be a concern, particularly in observational studies where positive or favorable results are more likely to be published. Additionally, given the widespread interest in pain management innovations like ECIP, there may be a tendency to publish studies that report positive outcomes, even when the findings are not robust. However, there is no specific indication from the study design itself to suggest selective reporting or significant bias. | Low Quality While the study includes a large sample size and directly relevant patient population, the lack of randomization and blinding introduces bias. Additionally, the results are not presented with sufficient statistical rigor to assess precision fully, though the sample size somewhat mitigates this concern. |
Singla et al., 2019 [26] | Low: The study was a phase III, multicenter, randomized, double-blind, placebo- and active-controlled trial, which is a robust and high-quality design for clinical trials. Randomization and blinding were performed, and the use of placebo and active comparators strengthens internal validity. | Moderate: The use of clinician-administered doses and the possibility of protocol deviations during the study may introduce some performance bias. In addition, while pain intensity and respiratory events were measured objectively, the interpretation of some outcomes (like respiratory safety events) may be subject to observer bias, as they depend on clinical judgment. Overall, though, the risk of bias appears minimal. | Low: The population and interventions are well-aligned with the clinical question of interest: pain management in post-surgical patients undergoing abdominoplasty. There are no significant issues with indirectness, as the study used appropriate comparators (morphine and placebo) and measured clinically relevant outcomes (pain intensity, respiratory safety). The study is directly applicable to the clinical scenario it seeks to address. | Low: The sample size (375 patients) was calculated to provide high statistical power (>88%) for key endpoints, such as superiority to placebo and noninferiority to morphine. The study design and power calculations suggest that imprecision is not a significant concern, as sufficient numbers were included to detect meaningful differences. | Low: As the study is part of a well-documented clinical trial with publicly available registration (NCT02820324) and conducted in a rigorous phase III setting, there is no evidence to suggest publication bias. However, as always with industry-sponsored trials, there is a potential risk that negative results from similar trials may not be published. Nonetheless, no direct evidence of publication bias is indicated here. | High Quality This study design and conduct were strong, with minimal risks of bias, indirectness, and imprecision. The high level of evidence suggests reliable conclusions can be drawn from the study’s findings. |
Elsawy et al., 2021 [27] | Moderate: The study is single-blinded, which may introduce bias in patient-reported outcomes. Randomization was present, but allocation concealment was not clearly mentioned. | Low: The results showed consistent findings with significantly lower VAS scores and prolonged analgesic effects in the ESP group across multiple time points. | Low: The population, intervention, and outcomes are directly relevant to the clinical question. The study population was specifically patients undergoing abdominoplasty. | Moderate: While the results are statistically significant, the sample size (51 patients) may not provide robust generalizability, and confidence intervals around the estimates were not reported. | Low: There is no indication of publication bias based on the outcomes; however, this cannot be definitively assessed without a systematic review of all available literature. | Moderate Quality Given the moderate risk of bias, moderate imprecision, and strong consistency in results, the overall quality of evidence is rated as moderate. |
Mansour et al., 2021 [28] | Low: The study is double-blinded and randomized, reducing the risk of bias significantly. The randomization process was clearly described, and informed consent was obtained. | Low: The outcomes were consistent across different time points and groups, with clear comparisons between the TAP and LK groups, showing statistically significant differences. | Low: The study population and interventions are directly relevant to the research question regarding pain management in abdominoplasty patients, with appropriate outcomes measured. | Moderate: While the sample size was adequate (50 patients), confidence intervals and specific p-values were not reported, which could affect the reliability of the results. | Low: There are no apparent indicators of publication bias, and the study’s outcomes seem to have been reported transparently. | High Quality The overall quality of evidence is moderate, reflecting low risk of bias, low inconsistency, and low indirectness, but moderate imprecision due to lack of detailed statistical reporting. |
Salama et al., 2018 [29] | Moderate: The study employed randomization and blinding for patients and outcome assessors, which helps reduce bias. However, the lack of blinding for the surgeon performing the procedure introduces potential bias in treatment administration and outcome assessment. | Low: The study appears consistent in its methodology and outcomes across the three groups. There were clear protocols for each intervention, and the outcomes measured (morphine consumption, NRS scores, etc.) are well-defined and comparable. | Low: The study population and interventions are directly relevant to the clinical question being addressed (pain management in patients undergoing abdominoplasty). The inclusion criteria ensure a focused patient group, minimizing indirectness in the applicability of results. | Moderate: While the sample size of 90 patients is reasonable for detecting differences, some outcomes may have wide confidence intervals due to variability in individual patient responses. Further details on the specific effect sizes and confidence intervals would enhance precision. | Low: The study does not indicate signs of publication bias, and prospective randomization suggests a lower likelihood of selective reporting. However, the assessment is limited due to the absence of systematic searches for unpublished studies or protocols to evaluate bias thoroughly. | Moderate Quality The overall quality of evidence is moderate, given the sound methodology, reasonable sample size, and clear outcomes. However, the potential for risk of bias from the unblinded surgical procedure and some concerns regarding imprecision may affect the robustness of the conclusions drawn from the study. |
Alotaibi et al., 2020 [30] | Low: The study is a randomized controlled trial with proper blinding and handling of dropouts and withdrawals | Low: The findings are consistent within the study. The outcomes indicate a clear distinction in pain management between the two groups, with a significant difference in opioid consumption and VAS scores. There is no indication of variability that would suggest inconsistency across similar studies. | Low: The study directly addresses the population of interest (patients undergoing lipoabdominoplasty) and the intervention (ultrasound-guided TAP block). This makes the evidence highly relevant and minimizes concerns about indirectness. | Moderate: While the sample size of 60 patients is reasonable, the findings regarding opioid consumption and pain scores could be subject to variability, especially if confidence intervals and effect sizes are not provided. This indicates a moderate level of imprecision in the estimates of the treatment effect. | Low: There is no indication of publication bias, as the study addresses a relevant clinical question and reports significant findings. | High Quality |
Farahat et al., 2023 [31] | Moderate: The study likely involved random allocation of patients to groups. However, potential biases in allocation concealment or blinding may exist, affecting the validity of results. | Low: Results between the groups (ESP-B and TAP-B vs. control) are consistent in terms of reduced opioid consumption and improved analgesia duration, suggesting low inconsistency. | Low: The study directly addresses the analgesic efficacy in the specific population (females undergoing abdominoplasty) and relevant interventions (ESP-B and TAP-B). | Moderate: While the study presents clear results, the sample size of 69 may limit the precision of the estimates, especially regarding rare events or specific outcomes. | Low: There is no indication of publication bias, as the study reports outcomes clearly and is likely to be part of the ongoing literature on multimodal analgesia. | Moderate Quality Considering the moderate risk of bias and imprecision, the overall quality of evidence is rated as moderate, indicating that further studies may be necessary to strengthen the findings. |
Kakagia et al., 2007 [32] | Low: The study uses appropriate randomization and blinding | Low: The results from different groups (saline, ropivacaine, levobupivacaine) seem consistent, assuming that the comparisons made are appropriate. No significant discrepancies in findings were mentioned. | Low: The study population appears directly relevant to the clinical question, as all patients underwent mini abdominoplasty, which is the focus of the investigation. | Moderate: While the sample size of 46 patients is reasonable, results could be imprecise if the confidence intervals of the outcomes are wide or not reported. | Low: No indication of publication bias is provided. The study seems to report its findings transparently. However, further data about the availability of studies could provide a clearer picture. | High Quality The study provides relevant insights into postoperative analgesia following mini abdominoplasty |
Sun et al., 2008 [33] | Low: The study has a well-defined randomization process and blinding for participants and staff | Low: The study appears consistent in its findings across treatment groups, with no conflicting results reported within the design or outcomes assessed. | Low: The study population is relevant to the research question, focusing on patients undergoing major plastic surgeries, which aligns well with the objectives of the study. | Low: The sample size is adequately large, with 120 participants in total | Low: There are no indications of publication bias in the methods or findings reported. The study seems to transparently report all relevant outcomes. | High Quality The methods employed are generally sound and appropriate for the study objectives. |
Michaels et al., 2009 [34] | Moderate: While the study involves a retrospective review of cases with a defined senior author, there is no mention of randomization and potential selection bias in grouping patients may affect the reliability of results. | Low: The outcomes reported for rib blocks versus general anesthesia show consistent results across the measures assessed (recovery room time, narcotics, nausea/vomiting, pain), with significant differences noted. | Low: The study population is relevant to the surgical context being examined, focusing specifically on abdominoplasty patients, allowing for direct application of findings. | Moderate: The sample sizes (39 in group 1 and 29 in group 2) are relatively small, which could affect the precision of the estimates. Detailed confidence intervals for the significant results were not provided, limiting interpretability. | Low: There is no indication of publication bias. The results appear to be reported transparently, with no selective outcome reporting evident. | Moderate Quality The overall quality is moderate, as the study employs a clear methodology and demonstrates significant findings; however, limitations in study design and sample size warrant cautious interpretation. |
Gravante et al., 2011 [35] | Moderate: The retrospective design introduces a potential for bias, particularly in patient selection and matching. While efforts were made to match groups for age and sex, residual confounding may still be present due to the nature of retrospective data. | Low: The study provides consistent results regarding postoperative pain management across the two groups, with clear outcomes related to analgesic requirements. | Low: The study population is relevant to the research question, focusing specifically on patients undergoing abdominoplasty with TAP blocks, allowing direct applicability of findings. | Moderate: The sample size of 51 patients is relatively small, which can reduce the precision of the results | Low: There are no indications of publication bias, as the study reports outcomes comprehensively and focuses on relevant measures. | Moderate Overall quality remains moderate due to the retrospective nature of the study and potential biases, but the clarity and consistency of results strengthen the findings. |
Meouchy et al., 2021 [36] | Low: The study used random allocation to assign patients to groups, which minimizes selection bias. | Low: The results are consistent, with significant differences noted in multiple outcomes (morphine and tramadol consumption, pain severity, and quality of recovery) between the two groups. | Low: The study’s population and interventions are directly relevant to the question posed, focusing on postoperative analgesia in patients receiving quadratus lumborum blocks. | Low: Results are statistically significant, with clear mean values and confidence in the measured outcomes, indicating low variability in the data. | Low: There are no indications of publication bias, as the study presents clear and relevant outcomes, and there are no conflicts of interest mentioned. | High Quality The overall quality of the evidence is high due to the low risk of bias, consistency, and clear outcomes measured. |
Sforza et al., 2024 [37] | Low: The study design is randomized and double-blind, reducing the risk of selection and performance bias. All participants had similar characteristics, and allocation concealment appears well-managed. | Low: The results are consistent across multiple time points, showing significant differences in pain scores and morphine requirements between the PECS and no-PECS groups. | Low: The study population and intervention are directly relevant to the research question regarding analgesia in breast augmentation surgery. | Low: Results are statistically significant with precise mean values and standard deviations provided for primary outcomes, indicating low variability in the findings. | Low: There are no indications of publication bias, as the study reports clear and relevant outcomes, and the protocol was approved by an ethical board. | High Quality The overall quality of evidence is high, with low risk of bias, consistency, directness, and precision in the findings. |
Feng 2010 [3] | Moderate: The study is retrospective and lacks randomization, which introduces potential selection bias. However, it uses a control group and evaluates a large sample size, which partially mitigates this concern. | Low: The results are consistent across different severity classes, showing significantly less pain and reduced narcotic use in the treatment group compared to the control group. | Low: The patient population and intervention are directly relevant to the question of pain management in abdominoplasty procedures. | Moderate: While the treatment effects are significant, the lack of detailed statistical analysis on variability (e.g., confidence intervals) limits the precision of the findings. | Low: There is no indication of publication bias, as the outcomes are clear and relevant, with a focus on clinical efficacy based on patient questionnaires. | Moderate Quality Overall, the study provides moderate-quality evidence due to the retrospective design and potential biases, despite strong findings regarding pain reduction and recovery. |
Araco et al., 2010 [38] | Moderate: The study is observational with potential for selection bias based on classification into TAP+ and TAP- groups. | Low: The results show consistent findings, with TAP+ patients significantly requiring less analgesia, indicating no significant variation in outcomes across the study population. | Low: The patient population and interventions evaluated directly address the question of TAP block efficacy in postoperative pain management after surgery. | Moderate: While the results indicate a significant reduction in analgesic requirements, the lack of detailed statistical measures (e.g., confidence intervals) limits the precision of the findings. | Low: There is no clear indication of publication bias as the outcomes reported are straightforward and based on clear clinical efficacy measures. | Moderate Quality The evidence suggests a positive impact of TAP blocks on reducing analgesia requirements postoperatively, but the observational nature and potential biases warrant a moderate quality rating. |
Wu et al., 2019 [39] | Low: The study is randomized and double-blinded, which minimizes selection and performance bias. Clear inclusion and exclusion criteria are well defined, enhancing the validity of the findings. | Low: The results are consistent across the different groups, with no significant differences in VAS scores and consumption of dezocine, supporting the reliability of the outcomes. | Low: The population, interventions, and outcomes directly relate to the research question. The study design is appropriate for assessing the efficacy of pain management techniques in LC. | Low: The sample size of 180 patients provides a robust data set, and outcomes are clearly reported. There are no indications of wide confidence intervals or uncertain estimates affecting the results. | Low: The study design and outcomes are straightforward and relevant to the clinical question, with no apparent indication of selective reporting or publication bias. | High Quality Given the low risk of bias, low inconsistency, low indirectness, low imprecision, and low publication bias, the overall quality of the evidence is high, indicating strong support for the study’s conclusions. |
Metry et al., 2019 [40] | Moderate: The study is randomized, but the blinding of participants and assessors is not explicitly stated. Selection bias is minimized through randomization, but without clear details on blinding, risk remains moderate. The exclusion criteria were also broad, which could introduce bias. | Low: Results appear consistent across outcomes measured, with similar patterns of pain scores and recovery times reported in both groups. No significant variability in the results is noted. | Low: The study directly addresses the clinical question of pain management techniques in abdominoplasty, using relevant outcomes such as VAS scores, total analgesic consumption, and patient satisfaction. The population is appropriate for the study’s aims. | Moderate: The sample size of 200 patients provides a reasonable power for detecting differences; however, specific confidence intervals or standard deviations for key outcomes were not provided, making precise interpretations challenging. | Low: The study is registered with a clinical trials registry, indicating an intent to publish, and reducing concerns about selective reporting. The outcomes seem to align with the registered protocol. | Moderate Quality Given the moderate risk of bias, low inconsistency, low indirectness, moderate imprecision, and low publication bias, the overall quality of evidence is moderate, suggesting the findings can be considered reliable but with some caution. |
Türkoglu et al., 2022 [41] | Moderate: The study design appears to involve randomization, but details about allocation concealment and blinding of participants and assessors are not provided, leaving potential for bias. The reporting of patient selection and any exclusions is also unclear, impacting the assessment of bias. | Low: The results show consistent findings regarding pain control across the three groups, with significant differences in VAS scores and analgesic consumption. No discrepancies in outcomes are noted, suggesting low inconsistency. | Low: The study directly addresses the clinical question of postoperative pain management in abdominoplasty patients, making the findings applicable to the target population and relevant outcomes. | Moderate: While the study provides significant results with clear differences in pain scores and opioid consumption, specific confidence intervals or standard deviations for the key outcomes are not mentioned, which can hinder precise interpretation. | Low: The study presents results with clear outcomes, and there is no indication of selective reporting. Given the straightforward nature of the intervention and outcomes, publication bias is unlikely. | Moderate Quality The overall quality of evidence is moderate, considering the moderate risk of bias, low inconsistency, low indirectness, moderate imprecision, and low publication bias. |
3.18. Limitations
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Article Number | Author and Year | Methodology | Sample Size (Abdominoplasties Only) | Age Mean/Range | Intervention(s) Used | Outcome(s) |
---|---|---|---|---|---|---|
1 | Beaton et al., 2023 [11] | RCT | 365 (181 bupivacaine, 184 placebo) | 18–65 | Bupivacaine implant vs. Placebo | Bupivacaine implant provided superior pain relief compared to placebo collagen implants in the first 24 h post-operation, with no significant difference at the 48 and 72 h marks |
2 | Abo-Zeid et al., 2018 [12] | RCT | 48 (16 TAP-B, 16 RS-B, 16 SCI) | NIL | TAP-B vs. RS-B vs. Subcutaneous infiltration (SCI) | TAP-Bs outperform RS-Bs and Sci in prolonging analgesia and reducing morphine requirements |
3 | Edwards et al., 2015 [13] | Prospective | 15 | 43 ± 13 | Liposome bupivacaine | A single intraoperative dose of liposome bupivacaine in breast surgery and abdominoplasty patients yielded consistently lower pain, reduced opioids, greater satisfaction, and fewer side effects compared to past clinical outcomes |
4 | Gardner et al., 2019 [14] | Prospective | 20 (10 RP, 10 TAP) | 43.8 (TAP) 38.8 (RP) /25–65 | Rectus plication (RP) block vs. Transverse abdominis plane (TAP) block | TAP-Bs prior to abdominoplasty significantly cut narcotic use, pain levels, and delayed pain medication requests, while also promoting early walking, proving their effectiveness as a post-surgical pain reliever. |
5 | Fiala 2015 [15] | Prospective | 32 (16 standard, 16 TAP) | 41.4 (standard) 44.8 (TAP) | Pararectus injections + ilioinguinal/iliohypogastric nerve blocks (standard) vs. TAP block | Patients receiving TAP blocks needed less postoperative hydromorphone and took longer to request pain medication, indicating more effective analgesia compared to standard nerve blocks after abdominoplasty |
6 | Minkowitz et al., 2020 [6] | RCT | 370 (136 placebo, 141 tramadol, 93 morphine) | 18–75 | IV tramadol 50 mg vs. IV morphine 4 mg vs. Placebo | IV tramadol at 50 mg outperformed a placebo and matched 4 mg IV morphine in postoperative pain management with fewer side effects, suggesting it as a favored opioid alternative. |
7 | Morales Jr. et al., 2013 [16] | Retrospective | 64 | 42/25–67 | Liposomal bupivacaine | Abdominal field block injections with liposomal bupivacaine in abdominoplasty significantly reduced postoperative pain, narcotic use, and expedited return to normal activities, suggesting its standard use in postoperative pain management |
8 | Price et al., 2023 [7] | Retrospective | 80 (42 control, 38 multimodal analgesia) | 37.3 (control) 42.6 (multimodal) | Multimodal approach (refer to Table 1 in study) | Less narcotic use and better pain control with multimodal medications, suggesting a need for surgeons to revise prescribing practices to combat the opioid crisis |
9 | Mentz et al., 2005 [17] | RCT | 20 (10 pain pump, standard pain meds) | NIL | Pain infusion pump (0.5% bupivacaine) vs. Standard pain meds | The group using a pain pump had significantly less postoperative pain, increased mobility, resumed activities sooner, and used fewer narcotics, suggesting its benefits may justify the cost in abdominal wall reconstruction |
10 | Singla et al., 2018 [18] | RCT | 219 (110 meloxicam, 109 placebo) | 38.9 ± 8.40 (melox) 41.0 ± 9.63 (placebo) /18–75 | IV meloxicam 30 mg vs. Placebo | Meloxicam IV significantly improved pain relief and reduced opioid rescue medication use compared to placebo in abdominoplasty patients, with a safety profile similar to placebo and no increased risk of typical NSAID-related adverse events |
11 | Bjelland et al., 2019 [19] | RCT | 50 (25 ropivacaine, 25 normal saline) | 42 (Ropivacaine) 40 (normal saline) /18–64 | Ropivacaine (3.75 mg/mL) vs. Normal saline (9 mg/mL) Both groups received a quadratus lumborum block | Quadratus lumborum block within multimodal pain management did not significantly reduce opioid needs or postoperative discomfort, with technical challenges encountered during administration and minimal observed benefit within the first 12 h postoperatively |
Article Number | Author and Year | Methodology | Sample Size (Abdominoplasties Only) | Age Mean/Range | Intervention(s) Used | Outcome(s) |
---|---|---|---|---|---|---|
1 | Ali et al., 2020 [20] | RCT | 160 total (80 with ketamine, 80 with morphine) | 33.03 ± 6.14 (K) 32.23 ± 5.21 (M) /18–50 | IV ketamine vs. IV morphine | Compared low-dose ketamine and morphine in abdominoplasty patients for analgesia efficacy and side effects, finding both equally effective without significant sedation or hallucinations |
2 | Giordano et al., 2020 [21] | Retrospective | 61 (24 PPC, 37 CAA) | 44.7 ± 9.1 (PPC) 40.5 ± 9.9 (CAA) | Pain pump catheter (PPC) vs. Conventional abdominoplasty analgesia (CAA) | The study favored PPCs with bupivacaine or ropivacaine for enhancing postoperative pain management and reducing opioid use and hospitalization in abdominoplasty |
3 | Shauly et al., 2022 [22] | Retrospective | 80 | 42.88 ± 2.40/25–68 | Liposomal bupivacaine intraop (within a pain protocol) | Patients undergoing lipoabdominoplasty with a multimodal analgesia protocol experienced low mean pain scores postoperatively, averaging 0.46/10 initially and 1.24/10 by day 7, with most switching to NSAIDs post-day 7 and nearly 94% reporting no pain at 4–6 weeks, highlighting the protocol’s effectiveness in pain management. |
4 | Varas et al., 2020 [23] | RCT | 63 (21 control, 20 ket grp, 22 ket-mag) | 40.2 ± 8.5 (control) 39.8 ± 6.1 (ket) 39.2 ± 7.2 (ket-mag) | IV 0.3 mg/kg ketamine + 50 mg/kg magnesium (KetMag)VS.Saline (control) vs. 1 bolus ketamine (ket grp) | Combining ketamine with magnesium significantly reduced morphine consumption and delayed its first request versus using ketamine alone or saline, without increasing adverse effects |
5 | Silva Filho et al., 2021 [24] | RCT | 43 (20 RG, 23 MSG) | 37.15 ± 10.33 (RG) 39.87 ± 6.57 (MSG) | Remifentanil group (RG) vs. Magnesium sulfate group (MSG) | Magnesium sulfate significantly reduced the need for additional analgesia and ephedrine while increasing propofol use, offering a safe and effective opioid-sparing option for intraoperative analgesia |
6 | Bray Jr. et al., 2007 [25] | Retrospective | 73 (38 local anesthetic pump, 35 standard pain meds) | NIL | Pain infusion pump (bupivacaine) vs. Standard pain meds | The use of pain pumps in abdominoplasty patients led to a minor, nonsignificant reduction in pain medication use and no significant improvement in pain scores or hospital stay |
7 | Chavez-Abraham et al., 2011 [10] | Retrospective | 425 (215 pump, 200 oral) | 47.3 (pump) 49.7 (oral) | Pain infusion pump (lidocaine) vs. Oral narcotics | Using a continuous-infusion pain pump significantly reduced perceived pain and oral narcotic (Vicodin™) use postoperatively in patients undergoing augmentation mammaplasty or abdominoplasty |
8 | Singla et al., 2019 [26] | RCT | 401 (81 placebo, 77 0.1 mg oliceridine, 80 0.35 mg oliceridine, 80 0.50 mg oliceridine, 83 1 mg morphine) | 41.4 ± 10.2 | Placebo vs. Oliceridine vs. Morphine | Oliceridine, at 0.35 and 0.5 mg doses, provided effective pain relief similar to morphine with fewer side effects in abdominoplasty patients, offering a viable alternative for acute pain management |
9 | Elsawy et al., 2021 [27] | RCT | 51 (25 ESP, 26 TAP) | NIL | Erector spinae plane (ESP) block vs. Transverse abdominis plane (TAP) block | ESP block significantly lowered pain scores at 8 and 12 h, delayed the first analgesic need, and reduced 24 h pethidine consumption compared to the TAP block |
10 | Mansour et al., 2021 [28] | RCT | 50 (25 L, 25 LK) | 25–50 | TAP block + levobupivacaine (L) vs. TAP block + levobupivacaine + ketamine (LK) | Adding 0.5 mg/kg ketamine to levobupivacaine for TAP blocks significantly reduced postoperative pain and morphine needs, and delayed the first request for rescue analgesia, improving analgesic effectiveness over levobupivacaine alone |
11 | Salama 2018 [29] | RCT | 90 (30 TAP + levobupivacaine, 30 infusions + levobupivacaine, 30 saline) | 41.6 ± 10.5 (TAP) 40.3 ± 11.7 (infusion) 42.1 ± 9.8 (saline) /25–50 | TAP + levobupivacaine vs. Infusion + levobupivacaine vs. Saline | Continuous bilateral ultrasound-guided TAP block and local anesthetic wound infusion significantly reduced morphine use and hastened first morphine dose and ambulation times in the first 48 h post-surgery compared to placebo, with no significant difference between the two techniques |
12 | Alotaibi et al., 2020 [30] | Retrospective | 60 (30 TAP, 30 no TAP) | NIL | TAP vs. No TAP | Patients receiving an ultrasound-guided TAP block post-lipoabdominoplasty needed significantly fewer postoperative opioids, had a longer time before their first analgesic request, had lower pain scores during mobilization, and experienced fewer instances of nausea and vomiting compared to the control group |
13 | Farahat et al., 2023 [31] | RCT | 69 (23 standard analgesia, 23 TAP block, 23 ESP block) | 25–65 | Standard analgesia vs. TAP block vs. Erector spinae plane (ESP) | ESP-B and TAP-B blocks had similar efficacies in managing postoperative pain, reducing heart rate spikes, cortisol levels, and the need for rescue analgesia with similar outcomes, despite ESP-B’s longer application time |
14 | Kakagia et al., 2007 [32] | RCT | 46 | (NS) 36.80 ± 4.33, (R) 37.20 ± 6.84, (L) 40.27 ± 7.83 | Normal saline (NS) vs. Ropivacaine (R) vs. Levobupivacaine (L) | In fleur-de-lys abdominoplasty, both ropivacaine and levobupivacaine reduced postoperative pain, with levobupivacaine showing superior effectiveness against pain intensity and duration |
15 | Sun et al., 2008 [33] | RCT | 112 (39 peri-op, 37 post-op, 36 control) | 42 ± 12 (control) 42 ± 14 (post-op) 43 ± 14 (peri-op) | Celcoxib Placebo Celcoxib vs. Placebo Celcoxib Celcoxib vs. Placebo Placebo Placebo | Celecoxib reduced postoperative pain, opioid need, and recovery time in plastic surgery, enhancing satisfaction without added preoperative benefit |
16 | Michaels et al., 2009 [34] | Retrospective | 68 (39 Grp 1, 29 Grp 2) | Grp 1: 44 Grp 2: 43 | General endotracheal analgesia (Grp 1) vs. Rib block (Grp 2) | Rib blocks before surgery significantly reduced recovery time, pain, postoperative narcotics, and nausea, enhancing patient comfort and making outpatient abdominoplasties more feasible without major complications |
17 | Gravante et al., 2011 [35] | Retrospective | 51 (27 PB, 24 aesthet) | 42 | Post-bariatric (PB) vs. Aesthetic abdominoplasty with frank liposuction Both groups received TAP block | Revealed no complications from anesthesia or TAP block technique in abdominoplasty patients, with those undergoing post-bariatric surgery requiring more analgesia, potentially due to larger tissue resection |
18 | Meouchy et al., 2021 [36] | RCT | 40 (20 ropivacaine, 20 normal saline) | Ropivacaine: 43.1 Saline: 45.6 | Ropivacaine vs. Normal saline Both groups received a bilateral quadratus lumborum block | Quadratus lumborum block decreased postoperative pain, lowered opioid consumption, and enhanced recovery quality compared to controls |
19 | Sforza et al., 2024 [37] | RCT | 30 (15 SPECS block, 15 normal saline) | 23–32 | Serratus anterior + Pectoral nerve block (S-PECS) vs. Normal Saline | S-PECS block significantly reduced pain and decreased postoperative medication needs in breast augmentation surgery |
20 | Feng 2010 [3] | Prospective | 97 (77 combination nerve blocks, 20 no blocks) | Combination: 45.7 ± 9 No blocks: 46.9 ± 9 | Intercostal + ilioinguinal + iliohypogastric + pararectus blocks (combination nerve blocks) vs. No blocks | Combining intercostal, ilioinguinal, iliohypogastric, and pararectus blocks in abdominoplasty provided long-term pain relief, reduced recovery time, and enhanced return to daily activities compared to controls |
21 | Araco et al., 2010 [38] | Retrospective | 75 (34 TAP-B, 41 no TAP-B) | TAP-B: 39 ± 8 No TAP-B: 42 ± 10 | TAP-B vs. No TAP-B | TAP-Bs were safe and effective for reducing postoperative opioid needs in aesthetic abdominal surgery, with no complications observed, but noted block failure in patients with higher BMI or larger flap resection, requiring additional analgesia |
22 | Wu et al., 2019 [39] | RCT | 180 (60 LAI, 60 TL, 60 RTR) | 48.0 ± 11.4 (LAI) 47.6 ± 10.1 (TL) 48.6 ± 12.1 (TR) /18–65 | Local anesthetic infiltrate (LAI) vs. Ultrasound-guided posterior TAP-B (TL) vs. Ultrasound-guided subcostal TAP-B combined with RS-B (TR) | No significant differences in postoperative outcomes among those receiving different pain management techniques, but the LAI group reported higher satisfaction within 48 h post-surgery |
23 | Metry et al., 2019 [40] | RCT | 200 (100 general anesthesia, 100 spinal anesthesia) | 39.1 ± 10.2 (GA) 36.6 ± 8.8 (SA) /25–55 | General anesthesia (GA) vs. Spinal anesthesia | Spinal group required less nalbuphine postoperatively, despite recording higher overall VAS scores than the general anesthesia group |
24 | Türkoglu et al., 2022 [41] | RCT | 47 (16 tramadol, 16 ibuprofen, 15 ibuprofen + tramadol) | 42.75 ± 13.17 (tramadol) 40.13 ± 11.13 (ibuprofen) 38.13 ± 7.88 (tramadol + ibuprofen) /18–65 | IV tramadol vs. IV ibuprofen vs. IV tramadol + ibuprofen | VAS values were significantly lower in Group 3 compared to both Group 1 and Group 2, while Group 3 also exhibited significantly lower total analgesic consumption compared to Group 1 |
Article | Randomization Process | Deviations from Intended Intervention | Missing Outcome Data | Measurement of Outcome | Selection of Reported Results | Overall Risk |
---|---|---|---|---|---|---|
Ali et al., 2020 [20] | Low Random allocation achieved via computer-generated number table. Method of concealment was not explicitly mentioned | Some concerns No explicit mention of how deviations from intended interventions were managed | Low 160/180 patients completed the study. However, not mentioned how missing data and dropouts were handled | Low Objective measures like the VAS and Ramsey scale were used | No information No explicit mention of any trial protocol being followed | Low |
Beaton et al., 2023 [11] | Low Randomization achieved using an electronic system. However, concealment method was not explicitly mentioned | Some concerns No explicit mention of how deviations from intended interventions were managed | Low Detailed description of trial process and follow-up were stated. Missing data likely addressed during these procedures | Low Patient-completed numerical pain rating scale and prespecified multiple timepoints for data collection indicates a standardized and objective approach to outcome measurement | Low Study protocol was registered. Use of statistical testing reduced risk of type I errors | Low |
Abo-Zeid et al., 2018 [12] | Low Randomization achieved using closed envelope method. Concealment method not explicitly mentioned | No information Insufficient information on the management of and adherence to the intervention protocols | No information No information about how missing data and dropouts were handled. | Low Post-op data were assessed by an independent anesthetist who was not informed about the technique | No information No mention of study protocol | High |
Minkowitz et al., 2020 [6] | Some concerns Details of randomization and concealment not provided | Some concerns No explicit information on how compliance was managed | Low Study used multiple imputation to handle missing data | Low SPID calculation was used to quantify efficacy of analgesia | Low Study was registered and conducted in accordance with the Helsinki Declaration | Low |
Varas et al., 2020 [23] | Low SealedEnvelopeTM software used for randomization. Nurse unrelated to the project was asked to handle randomization, ensuring blinding | Some concerns No explicit mention of how deviations from intended interventions were managed | Some concerns No information about how missing data and dropouts were handled. | Low One-way ANOVA, Kruskal–Wallis test, and Fisher’s exact test used to measure outcomes | Low Study was registered and conducted in accordance with the relevant protocol | Low |
Silva Filho et al., 2021 [24] | Low Electronic draw and opaque letters used to randomize participants. No explicit mention of concealment method | Some concerns No explicit mention of how deviations from intended interventions were managed | Some concerns No information about how missing data and dropouts were handled. | Low Two-way ANOVA used to measure primary outcome Verbal pain scale used to measure secondary outcome | Some concerns No mention of study protocol or registration | High |
Mentz et al., 2005 [17] | Some concerns No details about how the randomization or concealment process were conducted | Some concerns No explicit information on how compliance was managed | Some concerns No information about how missing data and dropouts were handled. | Some concerns While the study uses quantity of analgesic pills taken as a measure of pain control, it does not utilize direct observational scales (e.g., visual analogue scale) to evaluate pain control | Some concerns No mention of study protocol or registration | High |
Singla et al., 2019 [26] | Some concerns No details about how the randomization or concealment process were conducted | Some concerns No explicit information on how compliance was managed | Low Missing NRS pain scores were imputed by linear interpolation or a model-based multiple imputation method | Low Quantitative metrics were used to measure all outcomes Sufficient detail provided | Low Trial protocol approved by centralized institutional board through Advarra | Low |
Elsawy et al., 2021 [27] | Some concerns No details about how the randomization or concealment process were conducted | Some concerns No explicit information on how compliance was managed | Some concerns No mention about how missing data were handled | Low Visual analogue scale used to measure pain felt by participants | Low Trial approved by Ethics and Scientific Committee at Al-Azhar University’s Faculty of Medicine in Cairo | High |
Mansour et al., 2021 [28] | Low Randomization conducted using a computer-generated list and a sealed envelope method. However, details of concealment are not given | Some concerns No explicit information on how compliance was managed | Some concerns No mention about how missing data were handled | Low The primary outcome, VAS, is a subjective measure. The study mentions that an anesthesiologist blinded to group allocation conducted the assessments, which suggests a low risk of detection bias | Low Approval of the Ethical Committee of the Faculty of Medicine, Tanta University Hospital, followed by registration in the Pan African Clinical Trials Registry | Low |
Salama 2018 [29] | Low Randomization conducted using a computer-generated list and a sealed envelope method. However, details of concealment are not given | Some concerns No explicit mention of how deviations from intended interventions were managed | Some concerns No mention about how missing data were handled | Low Primary and secondary outcomes were objectively measured. Blinded assessors in the PACU and ward nurses collected the data | Some concerns No mention of study protocol or registration | High |
Farahat et al., 2023 [31] | Low Computer-generated algorithm and sealed envelope method used to randomize. However, no details about concealment were given | Some concerns No explicit mention of how deviations from intended interventions were managed | Some concerns No explicit mention of how missing data were handled | Low The outcomes, including total opioid consumption, time to first request for analgesia, and pain assessments, were clearly defined and measured | Low The study protocol was approved by the IRB at the Mansoura Faculty of Medicine. Clinical trial was registered in the ClinicalTrials.gov identifier | Low |
Kakagia et al., 2007 [32] | Low Random number generator used for allocation. No explicit details about concealment were given | Some concerns No explicit mention of how deviations from intended interventions were managed | Some concerns No explicit mention of how missing data were handled | Low Patients self-reported their pain using a visual analog scale (VAS) and that standard monitoring was used postoperatively | Some concerns No mention of study protocol or registration | High |
Sun et al., 2008 [33] | Low Computer-generated number schedule for patient allocation. All assessors were also blinded. | Some concerns No explicit mention of how deviations from intended interventions were managed | Some concerns No explicit mention of how missing data were handled | Low Outcomes were measured using standardized scales (VRS for pain, a 9-item questionnaire on quality of recovery), and an independent trained interviewer blinded to the study medication collected the data | Low IRB approval was achieved | Low |
Singla et al., 2018 [18] | Low Random number generator used for allocation. No explicit details about concealment were given | Some concerns No explicit mention of how deviations from intended interventions were managed | Some concerns No explicit mention of how missing data were handled | Low Pain intensity was assessed using a standardized 11-point numeric pain rating scale, and the performance of the study medication was evaluated using a patient global assessment | Low Trial was approved by the IRB | Low |
Sforza et al., 2024 [37] | Low The article clearly states that it is a randomized controlled trial, detailing who was responsible for the list and how they were absent during the procedure in the methods section | Some concerns No explicit information on how compliance was managed | Low All patients attended the mandatory appointments, suggesting that there were no missing outcome data and indicating a low risk of attrition bias | Low The study used a generalized estimating equation (GEE) with a logistic link to evaluate the effect of our main exposure, PECS, on the main outcome of pain medicine request, which was coded as a binary outcome (yes/no) | Low The study was approved by the hospital’s medical advisory board and adhered to the Declaration of Helsinki | Low |
Wu et al., 2019 [39] | Low The study describes a detailed randomization method using numbered opaque envelopes, suggesting a good attempt to prevent selection bias. | Some concerns No explicit information on how compliance was managed | Some concerns There is no information provided about how missing outcome data were handled, so we cannot determine if there is a high or low risk of bias in this domain. | Low A visual analogue scale (VAS) was used | Low The study received ethical approval from The First People’s Hospital of Hefei’s Ethics Committee (Approval No. 2015-11), was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-16009912), and adhered to the Declaration of Helsinki principles. All participants provided written informed consent. | Low |
Bjelland et al., 2019 [19] | Low The study utilized concealed computerized block randomization with a 1:1 allocation ratio, performed by the hospital pharmacy using an algorithm programmed in R | Some concerns The study lacks explicit discussion on adherence monitoring or deviation management | Some concerns The study does not detail how it handled any missing data | Low Outcomes were measured using objective criteria such as morphine equivalent units and numerical rating scales for pain, with methods like algometry for pain tolerance assessment | Low Registration with clinical trial registries (EudraCT and clinicaltrials.gov) supports transparency | Low |
Meouchy et al., 2021 [36] | Low The study used an internet-based randomization program to randomly allocate patients. They also used sealed envelopes which were opened by an independent nurse who was not involved in the randomization | Some concerns The study does not explicitly mention how it handled deviations in intervention | Some concerns The study does not detail how missing data were handled | Low The study used the numeric rating scale to score pain | Low Ethical approval was obtained from the Institutional Review Board of Hotel-Dieu de France Hospital | Low |
Metry et al., 2019 [40] | Low The study utilized a computer-created table of arbitrary numbers for random assignment | Some concerns The study does not explicitly mention how deviations in interventions, if any, were handled | Low The summary does not indicate any missing outcome data, suggesting that outcomes were reported for all participants | Low The study appropriately utilized the visual analogue scale (VAS) to analyze pain | Low The study is registered in ClinicalTrials.com with an ID number, and received ethical approval from the Ain Shams University Hospital | Low |
Türkoglu et al., 2022 [41] | Low The study utilized a computer-created table of random numbers for allocating patients to treatment groups | Some concerns The description does not provide sufficient detail to assess whether any deviations from the planned interventions occurred and how they were handled | Some concerns The study does not mention how missing data were addressed, making it difficult to assess the impact of any missing outcome data on the study’s validity | Low The study utilized standardized methods for measuring outcomes, such as VAS scores for pain, and monitored vital signs | Low The study received approval from the Bolu Abant İzzet Baysal University Clinical Studies Ethics Committee | Low |
Article | Confounding | Participant Selection | Classification of Interventions | Deviations from Intended Interventions | Missing Outcome Data | Measurement of Outcomes | Selection of Reported Result | Overall Risk |
---|---|---|---|---|---|---|---|---|
Edwards et al., 2015 [13] | Moderate Confounding exists due to variability in surgical procedures | Moderate Selection criteria not clearly described | Low Interventions clearly described | Moderate No explicit information on deviation from intended interventions or adherence to protocol being monitored | Moderate No explicit information on how missing data were handled | Moderate Measures multiple outcomes. However, lacks details on the reliability and validity of the measurement tools | Moderate Reports multiple outcomes with statistical tests applied. Does not provide information on whether adjustments were made for multiple comparisons, which increases potential for type I error | Moderate |
Giordano et al., 2020 [21] | Moderate No information about how confounding variables such as age, BMI, and medical history were controlled during allocation | Moderate Unclear representativeness of the study sample of the larger population | Low Interventions clearly described | Moderate No explicit information on deviation from intended interventions or adherence to protocol being monitored | Moderate No explicit information on how missing data were handled | Moderate Measures multiple outcomes. However, lacks details on the reliability and validity of the measurement tools | Moderate Not clear if all relevant outcomes were reported, or if unreported analyses exist | Moderate |
Gardner et al., 2019 [14] | Low Participants were randomized, however small sample size and other potential confounding variables pose a risk | Moderate Criteria are clear, however small sample size and specific inclusion criteria may limit generalizability of findings | Low Intervention clearly described | Moderate No explicit information on deviation from intended interventions or adherence to protocol being monitored | Moderate No explicit information on how missing data were handled. Can be significant given small sample size | Moderate Measures multiple outcomes. However, lacks details on the reliability and validity of the measurement tools | Moderate Statistical methods and significance levels specified. | Moderate |
Fiala 2015 [15] | Low Controls for confounding with detailed inclusion/exclusion criteria | Moderate Criteria for controlled and treatment groups not explicitly compared | Low Intervention clearly described | Low Technique of intervention is well detailed and study reports adherence to intended intervention | High No explicit information on how missing data were handled | Low Outcome measures relatively straightforward and measurement likely reliable | Low Study was registered and conducted in accordance with the relevant protocol | Moderate |
Shauly et al., 2022 [22] | Moderate Appears to control for confounding factors through detailed data collection. However, the impact of potential unmeasured confounders cannot be fully assessed in a retrospective study. | High Inclusion/exclusion criteria not explicitly mentioned. | Low Interventions clearly described | Moderate No explicit information on deviation from intended interventions or adherence to protocol being monitored | High No explicit information on how missing data were handled | Low Patient-reported pain scored reported using visual analog score (VAS). Measurement appears reliable | Low Study was registered and conducted in accordance with the relevant protocol | High |
Morales Jr. et al., 2013 [16] | Moderate Exclusion of 54 participants introduces selection bias | High Exclusion of 54 participants due to loss during follow-up introduces selection bias | Low Interventions clearly described | Low Study described a consistent intervention technique and a well-detailed method of administration | High Impact of missing data from 54 excluded participants on results not adequately addressed | Moderate Outcomes recorded using a subjective scale. No details on validity and reliability of pain management tool used | Low Study was registered and conducted in accordance with the relevant protocol | High |
Price et al., 2023 [7] | Moderate Study adjusts for participant demographics but does not provide details on additional potential confounders such as comorbidities | Low Clear selection criteria with no exclusions | Low Interventions clearly described | Moderate Experimental group not given option in choice of analgesia | Moderate No explicit information on how missing data were handled | Moderate Some outcomes are clearly defined. Does not estimate partial prescription use of intervention | Low Reports outcomes and utilizes statistical analysis to compare different aspects of pain management between two groups. Bonferroni correction used, and alpha value adjusted to decrease potential for type I error | Moderate |
Bray Jr. et al., 2007 [25] | Moderate Study does not provide details on how confounding variables are controlled | Low Clear selection criteria | Low Interventions clearly described | Moderate No explicit information on whether participants in certain group adhered to assigned intervention | Moderate No explicit information on how missing data were handled | Moderate Pain scores and medication were used at regular intervals, providing clear assessment of postoperative pain management. Did not adjust for multiple testing in statistical analysis which increases potential for type I error | Moderate Did not adjust for multiple testing which may impact reliability of results | Moderate |
Chavez-Abraham et al., 2011 [10] | Moderate Study does not provide details on how confounding variables are controlled | Low Clear selection criteria | Moderate Interventions clearly defined. Vague explanation on administration of lidocaine and its comparison | Moderate No explicit information on participant adherence to intervention | Moderate No explicit information on how missing data were handled | Moderate Lack of details on methods used for pain assessment | Moderate Reports outcomes related to pain level and narcotic use. Does not specify any statistical adjustments made for multiple comparisons which increases potential for type I error | Moderate |
Alotaibi et al., 2020 [30] | Moderate Study groups are compared for multiple variables, but still confounding variables are not addressed | Moderate Well defined inclusion/exclusion criteria but participants not randomized | Low Interventions clearly described | Moderate No explicit information on participant adherence to intervention | Moderate No explicit information on how missing data were handled | Moderate Measures multiple outcomes. However, lacks details on the reliability and validity of the measurement tools. | Moderate Reports multiple outcomes with statistical tests applied. Does not provide information on whether adjustments were made for multiple comparisons which increases potential for type I error | Moderate |
Michaels et al., 2009 [34] | Moderate Study groups are compared for multiple variables, but still confounding variables are not addressed | Moderate Well defined inclusion criteria but participants not randomized | Low Interventions clearly described | Moderate No explicit information on deviation from intended interventions or adherence to protocol being monitored | Moderate No explicit information on how missing data were handled | Moderate Measures multiple outcomes. However, it lacks details on the reliability and validity of the measurement tools. | Moderate Reports multiple outcomes with statistical tests applied. Does not provide information on whether adjustments were made for multiple comparisons which increases potential for type I error | Moderate |
Gravante et al., 2011 [35] | Moderate Study groups are compared for multiple variables, but still confounding are variables not addressed | Moderate Inclusion criteria not clearly defined | Low Interventions clearly described | Moderate No explicit information on deviation from intended interventions or adherence to protocol being monitored | Moderate No explicit information on how missing data were handled | Moderate Measures multiple outcomes. However, it lacks details on the reliability and validity of the measurement tools. | Moderate Reports multiple outcomes with statistical tests applied. Does not provide information on whether adjustments were made for multiple comparisons | Moderate |
Araco et al., 2010 [38] | Moderate The study does not account for other factors like preoperative health status or individual pain thresholds | Moderate Inclusion criteria only account for patients who underwent flank liposuction whereby the TAP technique was used | Low Interventions are well defined, with clear descriptions of the TAP technique and post-op care protocol | Some concerns The study does not go into detail on adherence to intended surgical and post-op protocols | Some concerns The study does not delineate how missing data were handled | Low The outcomes measured are objective (e.g., total bupivacaine injected, post-op morphine required) | Low Reports multiple outcomes with statistical tests applied | Moderate |
Feng 2010 [3] | Low A substantial number of factors were considered (age, gender, BMI, date and type of procedure, types and composition of blocks, pain score) | Moderate Patients were divided based on the period in which they underwent surgery, which might correlate with changes in practice over time rather than the intervention itself | Low The interventions are well described and classified, providing clear differentiation between treatment and control groups | Some concerns There is no information on whether there were any deviations from the planned interventions or how they were managed | Some concerns The study does not mention how missing data, if any, were handled | Moderate Outcomes were measured using standardized tools such as the visual analogue scale for pain and opioid equivalence charts for narcotics. However, the reliance on recovery room records and patient questionnaires sent 6 weeks postoperatively may introduce recall bias or variability in how outcomes were reported | Low Reports multiple outcomes with statistical tests applied such as the t-test and Mann–Whitney U test | Moderate |
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Lim, B.; Seth, I.; Cevik, J.; Ratnagandhi, J.A.; Bulloch, G.; Pentangelo, P.; Ceccaroni, A.; Alfano, C.; Rozen, W.M.; Cuomo, R. Innovations in Pain Management for Abdominoplasty Patients: A Systematic Review. J. Pers. Med. 2024, 14, 1078. https://doi.org/10.3390/jpm14111078
Lim B, Seth I, Cevik J, Ratnagandhi JA, Bulloch G, Pentangelo P, Ceccaroni A, Alfano C, Rozen WM, Cuomo R. Innovations in Pain Management for Abdominoplasty Patients: A Systematic Review. Journal of Personalized Medicine. 2024; 14(11):1078. https://doi.org/10.3390/jpm14111078
Chicago/Turabian StyleLim, Bryan, Ishith Seth, Jevan Cevik, Jeevan Avinassh Ratnagandhi, Gabriella Bulloch, Paola Pentangelo, Alessandra Ceccaroni, Carmine Alfano, Warren M. Rozen, and Roberto Cuomo. 2024. "Innovations in Pain Management for Abdominoplasty Patients: A Systematic Review" Journal of Personalized Medicine 14, no. 11: 1078. https://doi.org/10.3390/jpm14111078
APA StyleLim, B., Seth, I., Cevik, J., Ratnagandhi, J. A., Bulloch, G., Pentangelo, P., Ceccaroni, A., Alfano, C., Rozen, W. M., & Cuomo, R. (2024). Innovations in Pain Management for Abdominoplasty Patients: A Systematic Review. Journal of Personalized Medicine, 14(11), 1078. https://doi.org/10.3390/jpm14111078