Clinical trial NCT03750773: Gabapentin for Relief of Immediate Postoperative Pain
Official title: GRIPP: Gabapentin for Relief of Immediate Postoperative Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Postoperative Pain
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women at least 18 years of age
2. Gestational age \> or = to 30 weeks
3. Singleton gestation
4. Women undergoing a non-emergent cesarean delivery
5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
6. Ability to undergo the informed consent process in English

Exclusion Criteria:

1. Vertical skin incision
2. General anesthesia for cesarean
3. History of major depression or postpartum depression requiring medication
4. Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not include opioids given for labor anesthesia.
5. Magnesium sulfate treatment postpartum
6. Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder

Primary outcomes:
measure: Total morphine milligram equivalents consumed in the first 48 hours postoperatively
timeFrame: 48 hours
Secondary outcomes:
measure: Total morphine milligram equivalents from hospital discharge to one week postoperatively
timeFrame: one week
measure: Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively
timeFrame: 48 hours
measure: Number and type of adverse events potentially associated with study drug (Safety and Tolerability)
timeFrame: one week
Other outcomes:
Locations:
Study officials:
affiliation: IUSM, Dept OBGYN
name: David M Haas, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: