Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Last updated: March 26, 2025
Sponsor: Joseph Kowalski
Overall Status: Completed

Phase

4

Condition

Genitourinary Prolapse

Treatment

Gabapentin Placebo

Gabapentin

Clinical Study ID

NCT05658887
202207210
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

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

  • Female

  • Age 18 or higher

Exclusion

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

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Gabapentin Placebo
Phase: 4
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2024

Study Description

Enhanced Recovery after Surgery (ERAS) is an approach to perioperative care that focuses on evidence-based care protocols that emphasize minimizing stress and improving the body's response to stress. These protocols have resulted in a significant decrease in length of stay, complications, and cost in many different surgical specialities. Many of these protocols (including our current gynecology ERAS protocol) include preoperative gabapentin as an intervention to help reduce postoperative pain and postoperative opioid use. Gabapentin is an anticonvulsant medication that is commonly used for chronic neuropathic pain and other chronic pain disorders. The data regarding perioperative use of gabapentin is currently mixed, and the data in gynecology (and especially urogynecology) is limited. Notably gabapentin has been shown to be associated with sedation, respiratory depression, dizziness, and visual disturbances. In 2019, the U.S. Food and Drug Administration issued a warning that serious breathing difficulties may occur in patients using gabapentin with respiratory risk factors.

Pelvic organ prolapse is a common benign condition, and surgery for pelvic organ prolapse is very common. Vaginal apical suspension is one of the most common surgeries for pelvic organ prolapse. There is very limited data on the utility of preoperative gabapentin for vaginal apical suspension surgery.

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.

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

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