Title
Gabapentin for Perioperative Pain Relief in Surgical Abortion
Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial
Phase
Early Phase 1Lead Sponsor
University of Nevada, Las VegasStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Pain ControlIntervention/Treatment
Gabapentin ...Study Participants
219Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.
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.
Preoperative treatment with Gabapentin
Preoperative treatment with Placebo
Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Placebo (vit C) given 1-2 hours prior to surgical abortion
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
| Event Type | Organ System | Event Term |
|---|
100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain
Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme
Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme
100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain
