Liposomal Bupivacaine During Robotic Colpopexy and Posterior Repair: A Randomized Controlled Trial
Abstract
OBJECTIVE: To evaluate the effect of liposomal bupivacaine on postoperative pain among patients undergoing robotic sacrocolpopexy with posterior repair. METHODS: This was a randomized, patient-blinded, placebo-controlled trial of women undergoing robotic sacrocolpopexy with posterior repair. Liposomal bupivacaine or normal saline placebo was injected into laparoscopic and vaginal incisions at completion of surgery. Perioperative care was standardized. Visual analog scales were collected at 4, 18, and 24 hours postoperatively in hospital. Starting on postoperative day 1, participants completed twice-daily pain scales and a pain medication diary up until the evening of postoperative day 3. The primary outcome was a 20-mm change in the visual analog scale 18 hours postoperatively. Secondary measures included additional pain scores, satisfaction, and narcotic use. Sample size calculation revealed that 32 patients per arm were required to detect the 20-mm difference with 90% power and an α of 0.05. To allocate for dropout, a goal of 70 was set. RESULTS: Between March 2015 and April 2016, 100 women were screened and 70 women were enrolled: 35 women were randomized to liposomal bupivacaine and 35 to placebo, of whom 64 (91%) were included in the final analysis: 33 liposomal bupivacaine and 31 placebo. No difference in demographics, surgical data, or satisfaction between groups was noted. Median VAS at 18 hours after surgery was not statistically different in those who received liposomal bupivacaine compared with normal saline (15 mm compared with 20 mm;P=.52). Other pain scales and total morphine equivalents were also similar (P=.90). CONCLUSION: In this study of robotic sacrocolpopexy with posterior repair, there were no differences in pain scores or narcotic use between liposomal bupivacaine and placebo injected into laparoscopic and vaginal incisions. Given its lack of clinical benefit, routine use of liposomal bupivacaine is not supported for this surgical intervention. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02449915.
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There may be no clinically relevant difference in PGI-I outcomes between women who had short-acting versus long-acting bupivacaine.
“Based on evidence from a single trial (Yeung 2018), there may be no clinically relevant difference for PGI‐I outcomes between the two groups (OR 0.67, 95% CI 0.17 to 2.63; 1 study, 64 women; low‐certainty evidence; Analysis 6.3).”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the risk of selection bias from allocation concealment was low.
“Allocation concealment (selection bias) Low risk Sealed envelopes used with random participants”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the risk of reporting bias from selective reporting was low.
“Selective reporting (reporting bias) Low risk Reports main outcomes as per trial registry”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the risk of detection bias from blinding of outcome assessment was low.
“Blinding of outcome assessment (detection bias) All outcomes Low risk Blinded reviewers and women self‐completed validated pain scores on VAS”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the risk of selection bias from random sequence generation was unclear.
“Random sequence generation (selection bias) Unclear risk Permuted block randomisation on SPSS with 5 participants in each block; type of randomisation that is possible to have selection bias”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the risk of attrition bias from incomplete outcome data was low.
“Incomplete outcome data (attrition bias) All outcomes Low risk 64/64 women completed 1‐day VAS score and 62/64 women completed 3‐day VAS score (but studies not clear about in which arm were the losses to follow‐up)”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the risk of performance bias from blinding of participants and personnel was low.
“Blinding of participants and personnel (performance bias) All outcomes Low risk Participants blinded to allocation”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, a power calculation was performed.
“Power calculation: Sample size of 70 needed to detect 20 point difference in VAS pain scores with 90% power and P of 0.05 and accounting for 10% drop out”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the risk of other bias was low.
“Other bias Low risk Authors declared conflicts of interest: research grant from hospital medical education research grant”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
In Yeung 2018, the randomisation method was computer randomisation.
“Randomisation method: computer randomisation”
From Perioperative interventions in pelvic organ prolapse surgery (2025) · cites this paper as Yeung 2018
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- Authors
- Yeung, J., Crisp, C. C., Mazloomdoost, D., Kleeman, S. D., & Pauls, R. N.
- Affiliations
- Good Samaritan Hospital (US)
- Venue
- Obstetrics & Gynecology
- Published
- 2018-01
- Volume
- 131
- Issue
- 1
- Pages
- 39-46
- ISSN
- 0029-7844 (ISSN-L)
- OpenAlex
- W2774110033
- Cited by
- 34
- References
- 37
- Citations by year
- 2026: 2 · 2025: 1 · 2023: 2 · 2022: 7 · 2021: 6 · 2020: 6 · 2019: 4 · 2018: 5 · 2017: 1
- FWCI
- 4.48
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Obstetrics and Gynecology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Anesthesia and Pain Management
- Health Sciences › Medicine › Rheumatology › Pelvic floor disorders treatments
- Health Sciences › Medicine › Surgery › Hernia repair and management
- Keywords
- liposomal bupivacaine, robotic sacrocolpopexy, posterior repair, postoperative pain, local anesthetic injection, pelvic organ prolapse surgery, opioid use, gynecologic surgery
- MeSH terms
- Adult, Aged, Anesthetics, Local, Bupivacaine, Colposcopy, Female, Follow-Up Studies, Humans, Liposomes, Middle Aged, Pain Measurement, Postoperative Pain, Single-Blind Method, Treatment Outcome, Risk Assessment, Pelvic Organ Prolapse, Robotic Surgical Procedures
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