NCT03750773

Gabapentin for Relief of Immediate Postoperative Pain

GRIPP: Gabapentin for Relief of Immediate Postoperative Pain

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Gabapentin 600mg	Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
DRUG	Placebo oral capsule	Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.

Timeline

• Start date: 2019-07-02
• Primary completion: 2020-03-01
• Completion: 2020-04-01
• First posted: 2018-11-23
• Last updated: 2020-07-29