Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration (GABA)

Duke University

Status and phase: Completed; Phase 2

Conditions: Other Abortion; Spontaneous Abortion

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT02725710

Pro00063872

Details and patient eligibility

About

This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women >=18 years-old
• Presenting for a surgical abortion
• No contraindication to outpatient abortion
• No contraindication to gabapentin
• Fluency in English and able to provide informed consent

Exclusion criteria

• Allergy, sensitivity or contraindication to gabapentin
• Severe renal disease
• Currently using gabapentin or pregalabin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Group 1: Placebo

Active Comparator group

Description:

Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.

Treatment:

Drug: Placebo

Group 2: Gabapentin

Active Comparator group

Description:

Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.

Treatment:

Drug: Gabapentin