Preoperative Gabapentin for Pelvic Organ Prolapse

Overseen By Joseph Kowalski, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Joseph Kowalski

Must not be taking: Opioids, Gabapentinoids

Disqualifiers: Non-English, Incarcerated, Cognitive impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph Kowalski, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for women over 18 who are scheduled for vaginal prolapse surgery (sacrospinous ligament fixation or uterosacral ligament suspension). It's not open to chronic users of gabapentinoids, opioids, those with cognitive impairments, non-English speakers, incarcerated individuals, or anyone with a contraindication to acetaminophen, celecoxib, or gabapentinoids.

Inclusion Criteria

I am scheduled for a surgery to support the top of my vagina.

I am female.

Exclusion Criteria

Incarcerated

I am able to understand and give consent for my treatment.

Chronic opioid user

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive preoperative medication including gabapentin or placebo as part of the ERAS protocol

1 day

1 visit (in-person)

Surgery

Participants undergo vaginal apical suspension surgery

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for postoperative opioid use, pain, and adverse events

24 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Preoperative Gabapentin
• Preoperative Gabapentin Placebo

Trial Overview The study tests if preoperative Gabapentin reduces post-surgery opioid use compared to a placebo. Women will be randomly assigned either Gabapentin or a placebo in addition to standard pain management before their prolapse surgery. Both the patients and researchers won't know who receives which treatment.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin

Group II: Placebo Placebo Group 1 Intervention

Preoperative tylenol, preoperative celecoxib, preoperative gabapentin placebo

Who Is Running the Clinical Trial?

Joseph Kowalski

Lead Sponsor

Trials

2

Recruited

150+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+