Two Dose Epidural Morphine for Post-cesarean Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery
研究概览
简要总结
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.
详细描述
This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.
The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing cesarean section under epidural anesthesia.
排除标准
- •Emergent cesarean section
- •Coagulopathy
- •Failed epidural anesthesia or patchy block
- •General anesthesia
- •Use of epidural chloroprocaine
- •Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
- •Severe opioid side effects
- •History of chronic opioid use
- •History of chronic pain
- •History of obstructive sleep apnea
- •Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
- •Height under 4' 10" (147 cm)
- •Documented dural puncture by the epidural (Tuohy) needle
- •Preeclampsia
- •Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
研究组 & 干预措施
Epidural Morphine
Group receiving 3mg epidural morphine, 24 hours after the initial dose
干预措施: Epidural Morphine (Drug)
Epidural Saline
Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
干预措施: Epidural Saline (Drug)
结局指标
主要结局
The Average Amount of Intravenous Morphine Patients Self-administered in the Second 24 Hours Post-surgery
时间窗: Up to 48 hours post-operatively
The primary outcome of this study is the amount (mg) of morphine self-administered by PCA pump during the second 24 hours after surgery. This will be compared by unpaired t-test for two groups.
次要结局
未报告次要终点
研究者
Allison Lee
Assistant Professor of Anesthesiology
Columbia University