Gabapentin for Relief of Immediate Postoperative Pain (GRIPP)
Primary Purpose
Postoperative Pain
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Gabapentin 600mg
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Pregnant women at least 18 years of age
- Gestational age > or = to 30 weeks
- Singleton gestation
- Women undergoing a non-emergent cesarean delivery
- Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
- Ability to undergo the informed consent process in English
Exclusion Criteria:
- Vertical skin incision
- General anesthesia for cesarean
- History of major depression or postpartum depression requiring medication
- Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not include opioids given for labor anesthesia.
- Magnesium sulfate treatment postpartum
- Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Subjects receiving gabapentin drug
Subjects receiving placebo oral capsule
Arm Description
Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean
Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean
Outcomes
Primary Outcome Measures
Total morphine milligram equivalents consumed in the first 48 hours postoperatively
The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.
Secondary Outcome Measures
Total morphine milligram equivalents from hospital discharge to one week postoperatively
The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms.
Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively
Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively.
Number and type of adverse events potentially associated with study drug (Safety and Tolerability)
Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03750773
Brief Title
Gabapentin for Relief of Immediate Postoperative Pain
Acronym
GRIPP
Official Title
GRIPP: Gabapentin for Relief of Immediate Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
July 2, 2019 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery.
Detailed Description
This is a randomized, placebo controlled, double blind study. After consent, the subject will complete a Depression Screening to establish a baseline score. Within 2 hours following completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin) or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have the option to take routine opioid pain medication if her pain is uncontrolled. She will be asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For breastfeeding infants, data will be collected regarding overall feeding quality, somnolence levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin level while inpatient and any treatment for this as applicable. The subject will complete the Depression Scale again at 48 hours following delivery. At one week postpartum, they will receive a phone call and the following will be addressed: a final pain survey, a Depression survey, nausea level, number of pain pills left in their prescription, adverse events, whether or not they would take the study drug again if they should happen to have another cesarean section, and infant well-being if breastfeeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving gabapentin drug
Arm Type
Active Comparator
Arm Description
Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean
Arm Title
Subjects receiving placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean
Intervention Type
Drug
Intervention Name(s)
Gabapentin 600mg
Intervention Description
Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.
Primary Outcome Measure Information:
Title
Total morphine milligram equivalents consumed in the first 48 hours postoperatively
Description
The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Total morphine milligram equivalents from hospital discharge to one week postoperatively
Description
The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms.
Time Frame
one week
Title
Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively
Description
Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively.
Time Frame
48 hours
Title
Number and type of adverse events potentially associated with study drug (Safety and Tolerability)
Description
Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded
Time Frame
one week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women at least 18 years of age
Gestational age > or = to 30 weeks
Singleton gestation
Women undergoing a non-emergent cesarean delivery
Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
Ability to undergo the informed consent process in English
Exclusion Criteria:
Vertical skin incision
General anesthesia for cesarean
History of major depression or postpartum depression requiring medication
Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not include opioids given for labor anesthesia.
Magnesium sulfate treatment postpartum
Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Haas, MD, MS
Organizational Affiliation
IUSM, Dept OBGYN
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gabapentin for Relief of Immediate Postoperative Pain
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