Gabapentin for Perioperative Pain Relief in Surgical Abortion

Early Phase 1

Completed

• Conditions: Pain Control
• Interventions: Drug: Placebos; Drug: Gabapentin

• Registration Number: NCT04292171
• Lead Sponsor: University of Nevada, Las Vegas

Brief 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.

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-28
• Study First Posted: 2020-03-02
• Results First Submitted: 2020-04-10
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-06
• Last Update Submitted: 2020-11-06
• Results First Posted: 2020-12-02
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 219

Inclusion Criteria

• Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age.
• English or Spanish speaking
• eligible for office-based surgical pregnancy termination

Exclusion Criteria

• present use of gabapentin or pregabalin,
• renal disease
• sensitivity or allergy to gabapentin
• Missed abortion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebos	Placebo (vit C) given 1-2 hours prior to surgical abortion
Gabapentin Arm	Gabapentin	Gabapentin 600 mg given 1-2 hours prior to surgical abortion

Primary Outcome Measures

Name	Time	Method
Pain Score	5 minutes postoperative	100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain

Secondary Outcome Measures

Name	Time	Method
Nausea	24 hours postoperative	Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme
Pain Score 24	24 hours postop	Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain
Vomiting	24 hours postoperative	Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme
Pain Score at 30 Minutes Postoperative	30 minutes postoperative	100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain

Trial Locations

Locations (1)

Birth Control Care Center; 🇺🇸 Las Vegas, Nevada, United States