NCT05494385

Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-07-27
• Primary completion: 2023-06-17
• Completion: 2023-07-05
• First posted: 2022-08-10
• Last updated: 2024-10-23
• Results posted: 2024-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study