Gabapentin for Relief of Immediate Postoperative Pain (GRIPP)

GRIPP: Gabapentin for Relief of Immediate Postoperative Pain

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.

Study Overview

• Status: Withdrawn
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Gabapentin 600mg; Drug: Placebo oral capsule

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 Type: Interventional
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one week
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.	48 hours
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	one week

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: David M Haas, MD, MS, IUSM, Dept OBGYN

Study record dates

Study Major Dates

• Study Start (Anticipated): July 2, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 1809661339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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