GRIPP: Gabapentin for Relief of Immediate Postoperative Pain
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Total morphine milligram equivalents consumed in the first 48 hours postoperatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at least 18 years of age
- •Gestational age > or = to 30 weeks
- •Singleton gestation
- •Women undergoing a non-emergent cesarean delivery
- •Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
- •Ability to undergo the informed consent process in English
排除标准
- •Vertical skin incision
- •General anesthesia for cesarean
- •History of major depression or postpartum depression requiring medication
- •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.
- •Magnesium sulfate treatment postpartum
- •Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder
研究组 & 干预措施
Subjects receiving gabapentin drug
Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean
干预措施: Gabapentin 600mg (Drug)
Subjects receiving placebo oral capsule
Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Total morphine milligram equivalents consumed in the first 48 hours postoperatively
时间窗: 48 hours
The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.
次要结局
- Total morphine milligram equivalents from hospital discharge to one week postoperatively(one week)
- Number and type of adverse events potentially associated with study drug (Safety and Tolerability)(one week)
- Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively(48 hours)
研究者
David Haas
Robert A. Munsick Professor of Obstetrics and Gynecology with Tenure
Indiana University