MedTrace Logo

Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

NCT05494385 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-10-23

Study results available
· View outcomes & findings →

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Preoperative Gabapentin/Postoperative Placebo

Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.

DRUG

Preoperative Gabapentin/Postoperative Gabapentin

Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Douglass S Hale, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-27
Primary Completion
2023-06-17
Completion
2023-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05494385 on ClinicalTrials.gov