CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 114 enrolled
Drug / intervention
Preoperative Gabapentin/Postoperative Placebo +1 moredrug
Likely dose
Preoperative and postoperative gabapentin (encapsulated, dosage not specified); postoperative acetaminophen and ibuprofen every 6 hours; oxycodone 5 mg every 6 hours as neededAI-extracted
Key inclusion· 5
  • Women older than 18 years
  • English-speaking
  • Stage greater than 2 pelvic organ prolapse
  • Undergoing pelvic organ prolapse surgery (vaginal, laparoscopic, mesh-augmented, or obliterative procedure)
Key exclusion· 4
  • Renal dysfunction with creatinine clearance less than 60 mL/min
  • Allergy to acetaminophen or ibuprofen
  • Allergy to gabapentin
  • Currently on a Controlled Substance Agreement or Opioid Contract from another provider

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05494385
NCT05494385Phase 4Completed

Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Indiana University·interventional·Posted Aug 10, 2022·Updated Oct 23, 2024

In Brief

A Phase 4 clinical trial evaluating Preoperative Gabapentin/Postoperative Placebo and Preoperative Gabapentin/Postoperative Gabapentin for Postoperative Pain. Completed, enrolled 114 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedAug 10, 2022
Enrollment StartJul 27, 2021
Primary CompletionJun 17, 2023
Study CompletionJul 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 3.9 years ago

Interventions

Preoperative Gabapentin/Postoperative Placebodrug

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.

Preoperative Gabapentin/Postoperative Gabapentindrug

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.