Gabapentin as Adjunctive Treatment for Postoperative Pain Control
Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section
1 other identifier
interventional
13
1 country
2
Brief Summary
The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 3, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2017
CompletedAugust 23, 2017
August 1, 2017
1.7 years
July 1, 2015
August 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of opioid equivalents consumed
48 hours after cesarean delivery
Secondary Outcomes (3)
Amount of opioid equivalents consumed
one week after cesarean delivery
VAS pain scores
one week after cesarean delivery
Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions
one week after cesarean delivery
Study Arms (2)
Gabapentin Administration
ACTIVE COMPARATORgabapentin 600mg orally every 8 hours x 48 hours
Placebo
PLACEBO COMPARATORPlacebo , 1 tablet, orally every 8 hours x 48 hours
Interventions
Eligibility Criteria
You may qualify if:
- Pregnant women at least 18 years of age
- Singleton gestation
- Gestational age equal to or greater than 30 weeks
- Women undergoing a non-emergent (often scheduled) repeat cesarean delivery
- Spinal anesthesia utilized during cesarean
You may not qualify if:
- History of opiate abuse
- Women on opiates during pregnancy
- Women requiring treatment with magnesium sulfate postpartum
- Preexisting Fibromyalgia, chronic pain syndrome, or rheumatologic disorder
- General anesthesia required for cesarean
- Plans to breastfeed
- History of major depression or postpartum depression requiring medication
- Planned classical cesarean section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eskenazi Health
Indianapolis, Indiana, 46202, United States
Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Haas, MD, MS
Indiana School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- David Haas, MD, MS
Study Record Dates
First Submitted
July 1, 2015
First Posted
July 3, 2015
Study Start
October 1, 2015
Primary Completion
June 29, 2017
Study Completion
June 29, 2017
Last Updated
August 23, 2017
Record last verified: 2017-08