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Gabapentin for Postoperative Pain (GPOP Trial)

Phase < 1
Recruiting
Led By Lieschen Quiroz, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients have a diagnosis of uterovaginal prolapse, vaginal vault prolapse, or pelvic organ prolapse (based on International Classification of Diseases [ICD]).
Be older than 18 years old
Must not have
Current gabapentin or pregabalin use
Renal failure or glomerular filtration rate of < 30mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks post-op

Summary

This trial seeks to investigate if using gabapentin as part of post-op care helps reduce pain from minimally invasive surgery for prolapse.

Who is the study for?
This trial is for patients with different types of pelvic organ prolapse who are undergoing minimally invasive sacrocolpopexy. It's not for those currently on gabapentin or pregabalin, dependent on oxygen, with renal failure, or using daily narcotics for over two months.
What is being tested?
The study tests if Gabapentin can help manage pain after minimally invasive surgery to correct pelvic organ prolapse. Patients will either receive Gabapentin or a placebo to see which is more effective in reducing post-operative pain.
What are the potential side effects?
Gabapentin may cause side effects like dizziness, fatigue, visual changes and swelling in the extremities. Some people might also experience gastrointestinal issues such as diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of pelvic organ prolapse.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently taking gabapentin or pregabalin.
Select...
My kidney function is severely reduced.
Select...
I am having or have had surgery for sphincter/fistula repair, urethral issues, or mesh removal.
Select...
I need oxygen support.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Examine the efficacy of gabapentin in changing postoperative pain scores
Secondary study objectives
Somnolence
Patient satisfaction
Post-operative opioid consumption

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Gabapentin ArmActive Control1 Intervention
Standard ERAS protocol with scheduled postoperative gabapentin
Group II: Placebo ArmPlacebo Group1 Intervention
Standard ERAS protocol post-operative care with placebo

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
471 Previous Clinical Trials
93,413 Total Patients Enrolled
Lieschen Quiroz, MDPrincipal InvestigatorUniversity of Oklahoma
4 Previous Clinical Trials
333 Total Patients Enrolled

Media Library

Placebo (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05609682 — Phase < 1
Postoperative Pain Research Study Groups: Placebo Arm, Gabapentin Arm
Postoperative Pain Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05609682 — Phase < 1
Placebo (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05609682 — Phase < 1
~14 spots leftby Nov 2025
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