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Gabapentin as Adjunctive Treatment for Postoperative Pain Control

Information source: Indiana University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Drug Usage

Intervention: gabapentin (Drug); Placebo (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Indiana University

Official(s) and/or principal investigator(s):
David Haas, MD, MS, Principal Investigator, Affiliation: Indiana School of Medicine

Overall contact:
David Haas, MD, MS, Phone: 317-880-3960, Email: dahaas@iu.edu

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.

Clinical Details

Official title: Effect of Gabapentin on Pain Control After a Cesarean Section

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Amount of opioid equivalents consumed

Secondary outcome:

Amount of opioid equivalents consumed

VAS pain scores

Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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 with

history of ONE prior cesarean section

- 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

Locations and Contacts

David Haas, MD, MS, Phone: 317-880-3960, Email: dahaas@iu.edu

Eskenazi Health, Indianapolis, Indiana 46202, United States

Eskenazi Hospital, Indianapolis, Indiana 46202, United States

Additional Information

Starting date: September 2015
Last updated: August 20, 2015

Page last updated: August 20, 2015

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