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

Duke University96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Other Abortion Spontaneous Abortion

Interventions

GabapentinDRUG

600mg Gabapentin administered orally 1-2 hours prior to procedure

PlaceboDRUG

Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure

Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.

Time frame: 5 minutes

Secondary Outcomes

Pain Score on the 100-mm VAS

Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.

Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute

Perioperative Nausea as Measured by 100-mm VAS

Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.

Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

Number of Subjects Experiencing Perioperative Vomiting

Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

Perioperative Anxiety as Measured by the 100-mm VAS

Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.

Time frame: 5 minutes, 10 minutes, 30 minutes, discharge

Number of Subjects Using Pain Medications

Pain medications included ibuprofen and oxycodone.

Time frame: 24 hours post-operatively

Number of Subjects Experiencing Side Effects

Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.

Time frame: 10 minutes post-procedure

Data from ClinicalTrials.gov

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