Efficacy of Two Doses of Epidural Morphine for Analgesia After Traumatic Vaginal Delivery: a Randomized, Double Blinded, Placebo-controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Total breakthrough opioid consumption
研究概览
简要总结
This pilot study intends to establish the efficacy of 2 different doses of epidural morphine for pain management after perineal trauma when using multimodal analgesia as well as the feasibility of conducting a larger randomized clinical trial. Women with traumatic vaginal delivery will be randomized into 3 groups with 10 patients each and receive 2.5 mg epidural morphine, 1.25 mg epidural morphine, or epidural saline. The primary outcome is total opioid consumption for breakthrough pain in the first 24 hours.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patient is 18 years or older
- •The patient is ASA 1-3
- •Gestation 37-42 weeks
- •The patient had a vaginal delivery
- •The patient received epidural analgesia for labor and delivery
排除标准
- •The patient has refused to participate
- •The patient cannot give informed consent
- •The investigator has significant concerns for maternal or neonatal welfare
- •The patient has a history of allergy to opioids
- •The patient has a history of chronic opioid consumption
- •The patient has a history of narcotic abuse
- •The patient has an allergy to local anesthetics
- •The patient has a contraindication to taking NSAIDs or acetaminophen
- •The patient received combined spinal-epidural analgesia
- •The patient has a history of chronic pain
研究组 & 干预措施
Low dose epidural morphine
One dose of 1.25 mg epidural morphine
干预措施: Morphine (Drug)
High dose epidural morphine
One dose of 2.5 mg epidural morphine
干预措施: Morphine (Drug)
Saline
One dose of 10 ml saline administered through an epidural catheter
干预措施: Placebo (Drug)
结局指标
主要结局
Total breakthrough opioid consumption
时间窗: First 24 hours after delivery
次要结局
- Severity of nausea/vomiting(At 6, 12, 24, and 36 h after delivery)
- Total opioid consumption(First 36 h after delivery)
- Pain scores at rest(At 6, 12, 24, and 36 h after delivery)
- Severity of pruritis(At 6, 12, 24, and 36 h after delivery)
- Antipruritic medication consumption(First 36 h after delivery)
- Pain scores with movement(At 6, 12, 24, and 36 h after delivery)
- Severity of sedation(At 6, 12, 24, and 36 h after delivery)
- Time to first request for additional analgesia(First 36 h after delivery)
- Patient satisfaction with pain control(At 24 and 36 h after delivery)
- Quality of Recovery(At 24 and 36 h after delivery)
- Antiemetic consumption(First 36 h after delivery)