NCT00762554撤回不适用
A Comparison of Single Dose Depodur With Fentanyl Infusion for Post-Cesarean Section Analgesia
Goodman, Evan, M.D.1 个研究点 分布在 1 个国家开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Degree of analgesia (measured on a 10-point scale)
研究概览
简要总结
Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.
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
- Single (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
- 是
入选标准
- •Healthy pregnant women (ASA I or II) who are scheduled for an elective cesarean section
- •Patient appropriate for regional anesthesia
- •Patient agrees to receive regional anesthesia
- •Patient willing to have an epidural infusion of medication for two days postoperatively
排除标准
- •Morbid obesity
- •History of sleep apnea
- •Allergy to opioids medications
- •History of opioids use during week prior to procedure
- •Emergency cesarean section
- •Significant surgical complications
- •Contraindication or refusal to have regional anesthesia
- •Age less than 18
研究组 & 干预措施
1
Active Comparator
Epidural Depodur after spinal bupivacaine
干预措施: Depodur (Drug)
2
Active Comparator
Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine
干预措施: Fentanyl (Drug)
结局指标
主要结局
Degree of analgesia (measured on a 10-point scale)
时间窗: 48 hours post-operatively
次要结局
- Frequency of minor side effects, such as pruritis or nausea.(48 hours postoperatively)
研究者
Dr. Evan Goodman, MD
Anesthesiologist
Goodman, Evan, M.D.
研究点 (1)
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