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Gabapentin for Postoperative Pain (GPOP Trial)

Q: Does the trial include participants over 70 years of age?

This research is seeking to enrol participants who are at least 18 years old and no older than 99.

Q: Are participants still welcome to join this clinical experimentation?

According to the clinicaltrials.gov database, this medical trial is not currently searching for participants; it was initially posted on November 7th 2022 and has not been revised since then. Despite this, there are presently 484 other trials actively recruiting patients.

Q: Are there restrictions on who can participate in this scientific experiment?

This medical research is enrolling 40 eligible individuals aged 18 to 99 that are suffering from postoperative <a href="https://www.withpower.com/clinical-trials/pain">pain</a>, and have been diagnosed with uterovaginal prolapse, vaginal vault prolapse, or pelvic organ prolapse (as defined by the International Classification of Diseases [ICD]).

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks post-op

Awards & highlights

GPOP Trial 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.Check my eligibility

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.See study design

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.

GPOP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a type of pelvic organ prolapse.

GPOP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks post-op

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Examine the efficacy of gabapentin in changing postoperative pain scores

Secondary outcome measures

Somnolence

Patient satisfaction

Post-operative opioid consumption

GPOP 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,570 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the trial include participants over 70 years of age?

"This research is seeking to enrol participants who are at least 18 years old and no older than 99."

Answered by AI

Are participants still welcome to join this clinical experimentation?

"According to the clinicaltrials.gov database, this medical trial is not currently searching for participants; it was initially posted on November 7th 2022 and has not been revised since then. Despite this, there are presently 484 other trials actively recruiting patients."

Answered by AI

Are there restrictions on who can participate in this scientific experiment?

"This medical research is enrolling 40 eligible individuals aged 18 to 99 that are suffering from postoperative pain, and have been diagnosed with uterovaginal prolapse, vaginal vault prolapse, or pelvic organ prolapse (as defined by the International Classification of Diseases [ICD])."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Gabapentin on Post-Operative Pain in Minimally Invasive Sacrocolpopexy

2022. "Effect of Gabapentin on Post-Operative Pain in Minimally Invasive Sacrocolpopexy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05609682.

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