Gabapentin as Adjunctive Treatment for Postoperative Pain Control



Status:Active, not recruiting
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/4/2017
Start Date:October 2015
End Date:December 2017

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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.

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.

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
We found this trial at
2
sites
650 Eskenazi Avenue
Indianapolis, Indiana 46202
Phone: 317-880-3960
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Indianapolis, Indiana 46202
Phone: 317-880-3960
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials