Gabapentin for Relief of Immediate Postoperative Pain (GRIPP)

• ClinicalTrials.gov Identifier: NCT03750773
• Recruitment Status: Withdrawn
• First Posted: November 23, 2018
• Last Update Posted: July 29, 2020
• Sponsor: Indiana University
• Information provided by (Responsible Party): David Haas, Indiana University

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: Gabapentin 600mg; Drug: Placebo oral capsule	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Masking Description: Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study
• Primary Purpose: Treatment
• Official Title: GRIPP: Gabapentin for Relief of Immediate Postoperative Pain
• Estimated Study Start Date: July 2, 2019
• Estimated Primary Completion Date: March 2020
• Estimated Study Completion Date: April 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Subjects receiving gabapentin drug; Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean	Drug: Gabapentin 600mg; Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
Placebo Comparator: Subjects receiving placebo oral capsule; Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean	Drug: Placebo oral capsule; Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.

Outcome Measures

Primary Outcome Measures :

1. Total morphine milligram equivalents consumed in the first 48 hours postoperatively [ Time Frame: 48 hours ]
   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 :

1. Total morphine milligram equivalents from hospital discharge to one week postoperatively [ Time Frame: one week ]
   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.
2. Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively [ Time Frame: 48 hours ]
   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.
3. Number and type of adverse events potentially associated with study drug (Safety and Tolerability) [ Time Frame: one week ]
   Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Indiana University

Investigators

• Principal Investigator: David M Haas, MD, MS; IUSM, Dept OBGYN

More Information

• Responsible Party: David Haas, Robert A. Munsick Professor of Obstetrics and Gynecology with Tenure, Indiana University
• ClinicalTrials.gov Identifier: NCT03750773
• Other Study ID Numbers: 1809661339
• First Posted: November 23, 2018
• Last Update Posted: July 29, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Gabapentin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antimanic Agents