NCT02711072Unknown不适用
Comparaison of Continuous Infusion of Local Anesthetic and Intrathecal Morphine for Pain Management in Elective Caeserean Section
Tunisian Military Hospital0 个研究点目标入组 60 人开始时间: 2016年3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
- 发起方
- 入组人数
- 60
- 主要终点
- Visual Analogic Scale
研究概览
简要总结
SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?
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
- •ASA physical status I-II
- •18-45 years of age, inclusive
- •elective caeserean section under spinal anesthesia
排除标准
- •- contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
- •existing neurological deficit
- •inability to understand the informed consent and demands of the study
研究组 & 干预措施
control group
Placebo Comparator
干预措施: control group (Drug)
control group
Placebo Comparator
干预措施: infiltration group (Drug)
infiltration group
Active Comparator
干预措施: control group (Drug)
infiltration group
Active Comparator
干预措施: infiltration group (Drug)
结局指标
主要结局
Visual Analogic Scale
时间窗: until 48 hours postoperative
quality of postoperative analgesia
次要结局
- total dose of morphine consumption in mg(during 48 hours post operative)
- occurrence of complications(48 hours post operative)
研究者
Dr trabelsi walid
associate professor, MD
Tunisian Military Hospital
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