Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Amount of opioid equivalents consumed
研究概览
简要总结
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.
详细描述
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.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Gabapentin Administration
gabapentin 600mg orally every 8 hours x 48 hours
干预措施: gabapentin (Drug)
Placebo
Placebo , 1 tablet, orally every 8 hours x 48 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Amount of opioid equivalents consumed
时间窗: 48 hours after cesarean delivery
次要结局
- VAS pain scores(one week after cesarean delivery)
- Amount of opioid equivalents consumed(one week after cesarean delivery)
- Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions(one week after cesarean delivery)
研究者
David Haas
David Haas, MD, MS
Indiana University