Gabapentin as Adjunctive Treatment for Postoperative Pain Control
Primary Purpose
Drug Usage
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Drug Usage focused on measuring gabapentin
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Eskenazi Health
- Eskenazi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Gabapentin Administration
Placebo
Arm Description
gabapentin 600mg orally every 8 hours x 48 hours
Placebo , 1 tablet, orally every 8 hours x 48 hours
Outcomes
Primary Outcome Measures
Amount of opioid equivalents consumed
Secondary Outcome Measures
Amount of opioid equivalents consumed
VAS pain scores
Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02490345
Brief Title
Gabapentin as Adjunctive Treatment for Postoperative Pain Control
Official Title
Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 29, 2017 (Actual)
Study Completion Date
June 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
After consent has been obtained for the study and the cesarean has been completed, when the participant is in the recovery room, she will take the first pill of the study drug. This will occur approximately 30-60 minutes after the cesarean is completed. The time of first dose will be noted on the data capture form. The following will then occur:
Participants will take study capsules (either 600 mg gabapentin or placebo) every 8 hours for the first 48 hours after beginning the study. The nurse on the unit will be sent the study drug in a blinded capsule by the Investigational Pharmacy.
Participants will be asked about postoperative pain on a Visual Analog Scale by the care nurses or study personnel before each dose of study drug, before receiving any opioid medication, 2-4 hours after study drugs are consumed, at 24, 36 and 48 hours post surgery, and any other times during routine postoperative clinical care would warrant. Women record pain postoperatively on a similar scale as part of routine clinical care. Prescription pain medication will be given per clinical routine care. Study personnel will note how many pills were sent home.
One week (6-9 days) after the cesarean delivery, participants will be contacted by phone or other preferred method and asked about pain score, somnolence scores, dizziness, nausea, depression, any problems they are experiencing, and asked how many pain pills are left in their prescriptions given when they went home. These data will be recorded.
An Edinburgh Depression Scale will also be administered upon consent, at 48 hours, and again at one week after delivery. If the scores meet the specified criteria, the provider will by notified or if the subject has already been discharged from the hospital, she will be given contact information for follow up care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Usage
Keywords
gabapentin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin Administration
Arm Type
Active Comparator
Arm Description
gabapentin 600mg orally every 8 hours x 48 hours
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo , 1 tablet, orally every 8 hours x 48 hours
Intervention Type
Drug
Intervention Name(s)
gabapentin
Intervention Description
gabapentin usage as adjunctive treatment for pain control
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Identical placebo
Primary Outcome Measure Information:
Title
Amount of opioid equivalents consumed
Time Frame
48 hours after cesarean delivery
Secondary Outcome Measure Information:
Title
Amount of opioid equivalents consumed
Time Frame
one week after cesarean delivery
Title
VAS pain scores
Time Frame
one week after cesarean delivery
Title
Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions
Time Frame
one week after cesarean delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Haas, MD, MS
Organizational Affiliation
Indiana School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Gabapentin as Adjunctive Treatment for Postoperative Pain Control
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