Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joseph Kowalski
• Collaborator: University of Iowa
• Treatments: Gabapentin

Criteria

Inclusion Criteria:

• Scheduled for a vaginal apical support procedure (sacrospinous ligament fixation or vaginal uterosacral ligament suspension)

• Female

• Age 18 or higher

Exclusion Criteria:

• Non-English speaking

• Incarcerated

• Cognitive impairment precluding informed consent

• Chronic opioid user

• Chronic gabapentinoid user

• Contraindication to acetaminophen, celecoxib, or gabapentinoids

• Concurrent laparoscopic or abdominal surgery