Phase 4
Completed N=107
Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery
pelvic organ prolapse · Perioperative/Postoperative Complications
Source: ClinicalTrials.gov NCT05658887 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Postoperative Opioid Use — 25; 20 MMEs
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.