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 consumedVAS 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
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