The purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery.
This is a randomized, placebo controlled, double blind study. After consent, the subject will complete a Depression Screening to establish a baseline score. Within 2 hours following completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin) or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have the option to take routine opioid pain medication if her pain is uncontrolled. She will be asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For breastfeeding infants, data will be collected regarding overall feeding quality, somnolence levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin level while inpatient and any treatment for this as applicable. The subject will complete the Depression Scale again at 48 hours following delivery. At one week postpartum, they will receive a phone call and the following will be addressed: a final pain survey, a Depression survey, nausea level, number of pain pills left in their prescription, adverse events, whether or not they would take the study drug again if they should happen to have another cesarean section, and infant well-being if breastfeeding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.
Total morphine milligram equivalents consumed in the first 48 hours postoperatively
The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.
Time frame: 48 hours
Total morphine milligram equivalents from hospital discharge to one week postoperatively
The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms.
Time frame: one week
Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively
Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively.
Time frame: 48 hours
Number and type of adverse events potentially associated with study drug (Safety and Tolerability)
Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded
Time frame: one week
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