Gabapentin as Adjunctive Treatment for Postoperative Pain Control

NCT ID: NCT02490345

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-06-29

Brief Summary

The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control.

Detailed Description

After consent has been obtained for the study and the cesarean has been completed, when the participant is in the recovery room, she will take the first pill of the study drug. This will occur approximately 30-60 minutes after the cesarean is completed. The time of first dose will be noted on the data capture form. The following will then occur:

• Participants will take study capsules (either 600 mg gabapentin or placebo) every 8 hours for the first 48 hours after beginning the study. The nurse on the unit will be sent the study drug in a blinded capsule by the Investigational Pharmacy.
• Participants will be asked about postoperative pain on a Visual Analog Scale by the care nurses or study personnel before each dose of study drug, before receiving any opioid medication, 2-4 hours after study drugs are consumed, at 24, 36 and 48 hours post surgery, and any other times during routine postoperative clinical care would warrant. Women record pain postoperatively on a similar scale as part of routine clinical care. Prescription pain medication will be given per clinical routine care. Study personnel will note how many pills were sent home.
• One week (6-9 days) after the cesarean delivery, participants will be contacted by phone or other preferred method and asked about pain score, somnolence scores, dizziness, nausea, depression, any problems they are experiencing, and asked how many pain pills are left in their prescriptions given when they went home. These data will be recorded.

An Edinburgh Depression Scale will also be administered upon consent, at 48 hours, and again at one week after delivery. If the scores meet the specified criteria, the provider will by notified or if the subject has already been discharged from the hospital, she will be given contact information for follow up care.

Conditions

Drug Usage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gabapentin Administration

gabapentin 600mg orally every 8 hours x 48 hours

Group Type: ACTIVE_COMPARATOR

gabapentin

Intervention Type: DRUG

gabapentin usage as adjunctive treatment for pain control

Placebo

Placebo , 1 tablet, orally every 8 hours x 48 hours

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical placebo

Interventions

gabapentin

gabapentin usage as adjunctive treatment for pain control

Intervention Type: DRUG

Placebo

Identical placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pregnant women at least 18 years of age
• Singleton gestation
• Gestational age equal to or greater than 30 weeks
• Women undergoing a non-emergent (often scheduled) repeat cesarean delivery
• Spinal anesthesia utilized during cesarean

Exclusion Criteria

• History of opiate abuse
• Women on opiates during pregnancy
• Women requiring treatment with magnesium sulfate postpartum
• Preexisting Fibromyalgia, chronic pain syndrome, or rheumatologic disorder
• General anesthesia required for cesarean
• Plans to breastfeed
• History of major depression or postpartum depression requiring medication
• Planned classical cesarean section

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

David Haas

David Haas, MD, MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Haas, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana School of Medicine

Locations

Eskenazi Health

Indianapolis, Indiana, United States

Eskenazi Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1507497375

Identifier Type: -

Identifier Source: org_study_id