Back to resultsGabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration (GABA)
Primary Purpose
Other Abortion, Spontaneous Abortion
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Other Abortion focused on measuring uterine aspiration
Eligibility Criteria
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1: Placebo
Group 2: Gabapentin
Arm Description
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Number of Subjects Experiencing Perioperative Vomiting
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.
Number of Subjects Using Pain Medications
Pain medications included ibuprofen and oxycodone.
Number of Subjects Experiencing Side Effects
Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.
Pain (on a 5-point Scale)
Nausea (on a 5-point Scale)
Vomiting (on a 5-point Scale)
Side Effects (on a 5-point Scale)
General Satisfaction With the Procedure (on a 5-point Scale)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02725710
Brief Title
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration
Acronym
GABA
Official Title
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Other Abortion, Spontaneous Abortion
Keywords
uterine aspiration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Placebo
Arm Type
Active Comparator
Arm Description
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Arm Title
Group 2: Gabapentin
Arm Type
Active Comparator
Arm Description
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Neurontin
Intervention Description
600mg Gabapentin administered orally 1-2 hours prior to procedure
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
Primary Outcome Measure Information:
Title
Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
Description
Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Pain Score on the 100-mm VAS
Description
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
Title
Perioperative Nausea as Measured by 100-mm VAS
Description
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
Title
Number of Subjects Experiencing Perioperative Vomiting
Time Frame
Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Title
Perioperative Anxiety as Measured by the 100-mm VAS
Description
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
Title
Number of Subjects Using Pain Medications
Description
Pain medications included ibuprofen and oxycodone.
Time Frame
24 hours post-operatively
Title
Number of Subjects Experiencing Side Effects
Description
Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.
Time Frame
10 minutes post-procedure
Title
Pain (on a 5-point Scale)
Time Frame
Post-operative day 1
Title
Nausea (on a 5-point Scale)
Time Frame
Post-operative day 1
Title
Vomiting (on a 5-point Scale)
Time Frame
Post-operative day 1
Title
Side Effects (on a 5-point Scale)
Time Frame
Post-operative day 1
Title
General Satisfaction With the Procedure (on a 5-point Scale)
Time Frame
Post-operative day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Gray, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31403587
Citation
Gray BA, Hagey JM, Crabtree D, Wynn C, Weber JM, Pieper CF, Haddad LB. Gabapentin for Perioperative Pain Management for Uterine Aspiration: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):611-619. doi: 10.1097/AOG.0000000000003398.
Results Reference
derived
Learn more about this trial
Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration
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