Gabapentin for Perioperative Pain Relief in Surgical Abortion

Nevada System of Higher Education (NSHE)

Status and phase: Completed; Early Phase 1

Conditions: Pain Control

Treatments: Drug: Placebos; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT04292171

734275-7

Details and patient eligibility

About

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

Full 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.

Enrollment: 219 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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219 participants in 2 patient groups, including a placebo group

Gabapentin Arm

Active Comparator group

Description:

Gabapentin 600 mg given 1-2 hours prior to surgical abortion

Treatment:

Drug: Gabapentin

Placebo Arm

Placebo Comparator group

Description:

Placebo (vit C) given 1-2 hours prior to surgical abortion

Treatment:

Drug: Placebos