At a glance
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A Double-Blind Randomized Placebo-Controlled Clinical Trial of Preoperative Gabapentin Prior to Vaginal Apical Suspension Prolapse Procedures
In Brief
A Phase 4 clinical trial evaluating Gabapentin and Gabapentin Placebo for Pelvic Organ Prolapse and Perioperative/Postoperative Complications. Completed, enrolled 110 participants across 1 site.
Detailed Summary
This study will recruit women scheduled to undergo vaginal apical suspension surgery (either uterosacral ligament suspension or sacrospinous ligament fixation) with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to preoperative gabapentin or preoperative placebo (both patients and investigators will be blinded). Note the control group will receive preoperative acetaminophen/celecoxib/placebo and the treatment group will receive preoperative acetaminophen/celecoxib/gabapentin (preoperative acetaminophen/celecoxib are part of our current ERAS protocol). The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents.
Study Details
Timeline
Interventions
One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure
Gabapentin Placebo