Gabapentin for Relief of Immediate Postoperative Pain

NCT03750773 | Withdrawn Phase 1 DMC

• 1 other identifier: 1809661339
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Total morphine milligram equivalents from hospital discharge to one week postoperatively

  one week

• Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively

  48 hours

• Number and type of adverse events potentially associated with study drug (Safety and Tolerability)

  one week

Study Arms (2)

Subjects receiving gabapentin drug

ACTIVE COMPARATOR

Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean

Drug: Gabapentin 600mg

Subjects receiving placebo oral capsule

PLACEBO COMPARATOR

Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean

Drug: Placebo oral capsule

Interventions

Gabapentin 600mg DRUG

Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.

Subjects receiving gabapentin drug

Placebo oral capsule DRUG

Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.

Subjects receiving placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• David M Haas, MD, MS

  IUSM, Dept OBGYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Robert A. Munsick Professor of Obstetrics and Gynecology with Tenure

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 23, 2018
• Study Start: July 2, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share