Gabapentin as Adjunctive Treatment for Postoperative Pain Control

Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Drug Usage
• Intervention / Treatment: Drug: Placebo; Drug: gabapentin

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

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: Gabapentin Administration; gabapentin 600mg orally every 8 hours x 48 hours	Drug: gabapentin; gabapentin usage as adjunctive treatment for pain control
Placebo Comparator: Placebo; Placebo , 1 tablet, orally every 8 hours x 48 hours	Drug: Placebo; Identical placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of opioid equivalents consumed	48 hours after cesarean delivery

Secondary Outcome Measures

Outcome Measure	Time Frame
Amount of opioid equivalents consumed	one week after cesarean delivery
VAS pain scores	one week after cesarean delivery
Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions	one week after cesarean delivery

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: David Haas, MD, MS, Indiana School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): June 29, 2017
• Study Completion (Actual): June 29, 2017

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 21, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: gabapentin
• 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: 1507497375

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED