Preoperative Gabapentin vs Placebo for Vaginal Prolapse Surgery

Phase 4

Completed

• Conditions: Pelvic Organ Prolapse; Perioperative/Postoperative Complications
• Interventions: Drug: Gabapentin Placebo; Drug: Gabapentin

• Registration Number: NCT05658887
• Lead Sponsor: Joseph Kowalski

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-17
• Study First Posted: 2022-12-21
• Study Start: 2023-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Gabapentin Placebo	Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo
Intervention	Gabapentin	Preoperative tylenol, preoperative celecoxib, preoperative gabapentin

Primary Outcome Measures

Name	Time	Method
Postoperative opioid use	24 hours after surgery	Total postoperative opioid use in the first 24 hours postop measured in MME (starting when the patient leaves the operating room)

Secondary Outcome Measures

Name	Time	Method
postoperative opioid use	After surgery, max of 24 hours	postoperative opioid use while admitted
Time to discharge	After surgery, at the time the patient is discharged	Time (in hours) to discharge after surgery
Anti-emetic use	After surgery, max of 24 hours	Postoperative anti-emetic use
Number of patients that had an adverse event	After surgery until 24 hours postoperative	Adverse events
Mean postoperative pain score	After surgery, max of 24 hours	Mean postoperative pain score (using the validated numerical rating scale, minimum score 0, maximum score 10, higher scores mean worse pain/worse outcome) while admitted
Number of patients who report postoperative dizziness	24 hours postoperative	Patient reported postoperative dizziness
Number of patients who report sedation	24 hours postoperative	Patient reported sedation
Number of patients who report visual changes	24 hours postoperative	Patient reported visual changes
Number of patients who report postoperative nausea and vomiting	24 hours postoperative	Patient reported postoperative nausea and vomiting
Number of patients who report postoperative pain adequacy	24 hours postoperative	Patient reported postoperative pain adequacy

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States