Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial
Overview
- Phase
- Early Phase 1
- Intervention
- Gabapentin
- Conditions
- Pain Control
- Sponsor
- University of Nevada, Las Vegas
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- Pain Score
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Adam Levy
Associate Professor, OB/GYN
University of Nevada, Las Vegas
Eligibility Criteria
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
Arms & Interventions
Gabapentin Arm
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Intervention: Gabapentin
Placebo Arm
Placebo (vit C) given 1-2 hours prior to surgical abortion
Intervention: Placebos
Outcomes
Primary Outcomes
Pain Score
Time Frame: 5 minutes postoperative
100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
Secondary Outcomes
- Nausea(24 hours postoperative)
- Pain Score 24(24 hours postop)
- Vomiting(24 hours postoperative)
- Pain Score at 30 Minutes Postoperative(30 minutes postoperative)