NCT04292171

Gabapentin for Perioperative Pain Relief in Surgical Abortion

Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: University of Nevada, Las Vegas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.

Detailed description

A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.

Conditions

• Pain Control

Interventions

Type	Name	Description
DRUG	Gabapentin	Preoperative treatment with Gabapentin
DRUG	Placebos	Preoperative treatment with Placebo

Timeline

• Start date: 2017-05-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2020-03-02
• Last updated: 2020-12-02
• Results posted: 2020-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study