Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse

Phase 4 Completed 70 enrolled TriHealth Inc.

RandomizedParallel-groupDouble-blindSupportive care

Summary

To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

Timeline

Start: 2015-03
Primary completion: 2016-08
Completion: 2016-08

Outcome

Missed primary endpoint

paper was not statistically different in those who received liposomal bupivacaine compared with normal saline (15 mm compared with 20 mm; P=.52). PMID 29215511 ↗

Publications

Yeung J, Crisp CC, Mazloomdoost D, Kleeman SD, Pauls RN. Liposomal Bupivacaine During Robotic Colpopexy and Posterior Repair: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):39-46. doi: 10.1097/AOG.0000000000002375.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupivacaine	Other / unclassified	30 ml	Other