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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking gabapentin, a medication often used for nerve pain, before surgery can reduce the need for opioids after surgery for pelvic organ prolapse. Women scheduled for specific types of vaginal surgery will receive either gabapentin or a placebo (a pill with no active drug) before their procedure. The researchers aim to determine if gabapentin can better manage pain, thereby reducing opioid use after surgery. Women set for vaginal apical support surgery who do not regularly use opioids or gabapentinoids are ideal candidates for this trial. As a Phase 4 trial, this research examines how the already FDA-approved gabapentin might benefit more patients by potentially reducing opioid use post-surgery.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are a chronic user of opioids or gabapentinoids, you cannot participate in the trial.

What is the safety track record for preoperative gabapentin?

Research shows that gabapentin is usually well-tolerated, but some people may experience side effects. In earlier studies, participants reported feeling sleepy or dizzy after taking gabapentin. Some also experienced breathing problems and changes in vision. However, limited information exists about using gabapentin around the time of surgery, especially for pelvic organ prolapse, and the results are mixed.

This study is in a late phase, indicating that gabapentin has been considered safe enough for testing in larger groups. The FDA has already approved gabapentin for other uses, which can reassure about its safety. However, this does not mean it is completely risk-free for everyone. Participants should discuss any concerns with their healthcare provider before joining the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for pelvic organ prolapse focus on surgical repair or support devices. However, preoperative gabapentin is unique because it targets pain management before surgery, potentially reducing postoperative discomfort and improving recovery. Gabapentin works by calming nerve activity, which is different from traditional painkillers that primarily focus on reducing inflammation or blocking pain signals. Researchers are excited about gabapentin because it could offer a more comprehensive pain management strategy, making the surgical experience smoother and less painful for patients.

What evidence suggests that preoperative gabapentin might be an effective treatment for reducing postoperative opioid use in pelvic organ prolapse surgery?

Research suggests that taking gabapentin before surgery might reduce the need for opioids afterward. Although studies have shown mixed results, gabapentin can help manage pain for some surgeries. In this trial, participants will receive either preoperative gabapentin or a placebo to evaluate its effectiveness specifically for pelvic organ prolapse surgeries. Gabapentin has shown promise in reducing pain and, consequently, the amount of opioids needed after surgery. Researchers continue to study its effectiveness in this context, but it is believed to work by calming nerve activity, which can help control pain. ^{1 2 4 5 6}

Who Is on the Research Team?

Joseph Kowalski, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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

Chronic opioid user

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05658887

Preoperative Gabapentin vs Placebo for Vaginal Prolapse ... The data regarding perioperative use of gabapentin is currently mixed, and the data in gynecology (and especially urogynecology) is limited. Notably gabapentin ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/87/NCT05658887/Prot_SAP_000.pdf

A Double-Blind Randomized Placebo-Controlled Clinical ... 16 The data regarding perioperative gabapentin in surgery for pelvic organ prolapse is very limited. ... effects of perioperative gabapentin in ...

3. withpower.com withpower.com/trial/phase-4-prolapse-2023-f3a0c

Preoperative Gabapentin for Pelvic Organ Prolapse The primary outcome will be postoperative opioid use in the first 24 hours postoperatively measured in morphine milligram equivalents. Show more. Who Is on the ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05658887/preoperative-gabapentin-vs-placebo-for-vaginal-prolapse-surgery

Preoperative Gabapentin vs Placebo for Vaginal Prolapse ... The data regarding perioperative use of gabapentin is currently mixed, and the data in gynecology (and especially urogynecology) is limited.

5. ajog.org ajog.org/article/S0002-9378(21)00289-1/pdf

Impact of timing of preoperative gabapentin administration ... Our primary outcome was 30-day surgical site infection (superficial/incisional and deep/organ space infections). Demographic and clinical characteristics were ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7250460/

Pain and activity after vaginal reconstructive surgery ... Beyond these reported adverse events, there are few data available on the short- and long-term pain and functional activity after surgery for pelvic organ ...