Preoperative Gabapentin for Pelvic Organ Prolapse

Recruiting in Palo Alto (17 mi)

Overseen byJoseph Kowalski, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Joseph Kowalski

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for women over 18 who are scheduled for vaginal prolapse surgery (sacrospinous ligament fixation or uterosacral ligament suspension). It's not open to chronic users of gabapentinoids, opioids, those with cognitive impairments, non-English speakers, incarcerated individuals, or anyone with a contraindication to acetaminophen, celecoxib, or gabapentinoids.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for a surgery to support the top of my vagina.

I am female.

Exclusion Criteria

I do not speak English.

Incarcerated

I am able to understand and give consent for my treatment.

+4 more

Participant Groups

The study tests if preoperative Gabapentin reduces post-surgery opioid use compared to a placebo. Women will be randomly assigned either Gabapentin or a placebo in addition to standard pain management before their prolapse surgery. Both the patients and researchers won't know who receives which treatment.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 Intervention

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin

Group II: PlaceboPlacebo Group1 Intervention

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo