Phase 4
N=107
Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
Pelvic Organ Prolapse · Perioperative/Postoperative Complications
Bottom Line
View on ClinicalTrials.gov: NCT05658887 ↗Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Postoperative Opioid Use — 25; 20 MMEs
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin (Drug); Gabapentin Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Joseph Kowalski
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Opioid Use |
25; 20 | — |
| SECONDARY Mean Postop Pain Score |
3.5; 3.25 | — |
| SECONDARY Postoperative Opioid Use While Admitted in the Hospital |
20; 16 | — |
| SECONDARY Time to Discharge |
528; 542 | — |
| SECONDARY Number of Patients Who Report Postoperative Dizziness |
13; 7 | — |
| SECONDARY Number of Patients Who Report Sedation |
4; 2 | — |
| SECONDARY Number of Patients Who Report Visual Changes |
1; 1 | — |
| SECONDARY Number of Patients Who Report Postoperative Nausea |
14; 10 | — |
| SECONDARY Number of Patients Who Report Postoperative Pain Adequacy |
40; 41 | — |
| SECONDARY Morphine Milligram Equivalents (MMEs) of Preoperative and Intraoperative Opioids |
46; 40 | — |
| SECONDARY Estimated Blood Loss |
25; 50 | — |
| SECONDARY Surgery Length |
152; 147 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT05658887). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.