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

June 12, 2019 updated by: Duke University

Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Placebo
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Drug: Placebo
Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
Other Names:
  • sugar pill
Active Comparator: Group 2: Gabapentin
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Drug: Gabapentin
600mg Gabapentin administered orally 1-2 hours prior to procedure
Other Names:
  • Neurontin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
Time Frame: 5 minutes
Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score on the 100-mm VAS
Time Frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute
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.
Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute
Perioperative Nausea as Measured by 100-mm VAS
Time Frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.
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
Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Perioperative Anxiety as Measured by the 100-mm VAS
Time Frame: 5 minutes, 10 minutes, 30 minutes, discharge
Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.
5 minutes, 10 minutes, 30 minutes, discharge
Number of Subjects Using Pain Medications
Time Frame: 24 hours post-operatively
Pain medications included ibuprofen and oxycodone.
24 hours post-operatively
Number of Subjects Experiencing Side Effects
Time Frame: 10 minutes post-procedure
Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.
10 minutes post-procedure
Pain (on a 5-point Scale)
Time Frame: Post-operative day 1
Post-operative day 1
Nausea (on a 5-point Scale)
Time Frame: Post-operative day 1
Post-operative day 1
Vomiting (on a 5-point Scale)
Time Frame: Post-operative day 1
Post-operative day 1
Side Effects (on a 5-point Scale)
Time Frame: Post-operative day 1
Post-operative day 1
General Satisfaction With the Procedure (on a 5-point Scale)
Time Frame: Post-operative day 1
Post-operative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Beverly Gray, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

June 13, 2018

Study Completion (Actual)

June 14, 2018

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (Estimate)

April 1, 2016

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 12, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00063872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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