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Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

NCT05658887 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-08-12

Study results available
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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.

Conditions

  • Pelvic Organ Prolapse
  • Perioperative/Postoperative Complications

Interventions

DRUG

Gabapentin

One dose of preoperative gabapentin 300 mg prior to vaginal apical support procedure

DRUG

Gabapentin Placebo

Gabapentin Placebo

Sponsors & Collaborators

  • University of Iowa

    collaborator OTHER

  • Joseph Kowalski

    lead OTHER

Principal Investigators

  • Joseph Kowalski, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05658887 on ClinicalTrials.gov