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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Withdrawn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
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pregnant women at least 18 years of age
  2. Gestational age > or = to 30 weeks
  3. Singleton gestation
  4. Women undergoing a non-emergent cesarean delivery
  5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
  6. Ability to undergo the informed consent process in English

Exclusion Criteria:

  1. Vertical skin incision
  2. General anesthesia for cesarean
  3. History of major depression or postpartum depression requiring medication
  4. 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.
  5. Magnesium sulfate treatment postpartum
  6. 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

    First Posted
    November 16, 2018
    Last Updated
    July 27, 2020
    Sponsor
    Indiana University
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    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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