Preoperative Gabapentin/Postoperative Gabapentin for Postoperative Pain

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Indiana University School of Medicine, Indianapolis, IN
Postoperative Pain+1 More
Preoperative Gabapentin/Postoperative Gabapentin - Drug
Eligibility
18+
Female
What conditions do you have?
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Study Summary

The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.

Eligible Conditions

  • Postoperative Pain

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Length of postoperative hospital stay (typically less than 48 hours)

6 weeks
Opioid Refill Requests
Hour 48
Inpatient Morphine Milligram Equivalents
Inpatient Pain Scores
Length of Stay
Nausea
Opioid Prescription at Discharge
Sedation

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Preoperative Gabapentin/Postoperative Gabapentin
1 of 2
Preoperative Gabapentin/Postoperative Placebo
1 of 2
Active Control
Non-Treatment Group

130 Total Participants · 2 Treatment Groups

Primary Treatment: Preoperative Gabapentin/Postoperative Gabapentin · Has Placebo Group · Phase 4

Preoperative Gabapentin/Postoperative Placebo
Drug
PlaceboComparator Group · 1 Intervention: Preoperative Gabapentin/Postoperative Placebo · Intervention Types: Drug
Preoperative Gabapentin/Postoperative Gabapentin
Drug
ActiveComparator Group · 1 Intervention: Preoperative Gabapentin/Postoperative Gabapentin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: length of postoperative hospital stay (typically less than 48 hours)
Closest Location: Indiana University School of Medicine · Indianapolis, IN
Photo of indianapolis 1Photo of indianapolis 2Photo of indianapolis 3
2001First Recorded Clinical Trial
2 TrialsResearching Postoperative Pain
147 CompletedClinical Trials

Who is running the clinical trial?

Indiana UniversityLead Sponsor
858 Previous Clinical Trials
543,452 Total Patients Enrolled
4 Trials studying Postoperative Pain
1,770 Patients Enrolled for Postoperative Pain
Douglass S Hale, MDPrincipal InvestigatorIndiana University School of Medicine

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are undergoing a pelvic organ prolapse procedure.
You must be a woman > 18 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.