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临床试验/CTRI/2019/08/020801
CTRI/2019/08/020801招募中2/3 期

Comparison of post-operative analgesia with caudal ropivacaine and levobupivacaine in paediatric patients undergoing infraumbilical surgery under general anaesthesia

Department of anaesthesia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月9日最近更新:

试验速览

阶段
2/3 期
状态
招募中
入组人数
60
试验地点
1
主要终点
1. Quality of analgesia by MOPS Score after administration of 0.25% caudal levobupivacaine

研究概览

简要总结

caudal epidural anaesthesia is a widely used technique in pediatric infraumbilical surgery . use of postoperative analgesia via the caudal epidural route with bupivacaine in pediatric patient is established in infraumbilical surgery . levobupivacaine and ropivacaine provide wider margine of safety , same analgesic effect and less post operative motor block than racemic mixture of bupivacaine in epidural block and both are well tolerated . so we proposed to evaluate the quality and duration of post operative analgesia and any side effects while using caudal block with ropivacaine and levobupivacaine

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • pediatric patients of either sex with ASA physical status I&II, 2 to 6 yrs of age undergoing infraumbilical surgery.

排除标准

  • local infection at injection site, Neurological disorders, allergy to local anaesthetic drug, sacral or vertebral abnormality, coagulopathy or anti-coagulation.

结局指标

主要结局

1. Quality of analgesia by MOPS Score after administration of 0.25% caudal levobupivacaine

时间窗: MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given

2. Quality of analgesia by MOPS Score after administration of 0.25% caudal ropivacaine

时间窗: MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given

3. Duration of post operative analgesia by time to first rescue analgesia.

时间窗: MOPS scoring will be done every 30 minutes for 2 hours after reversal of anesthesia, then hourly till the time first rescue analgesia given

次要结局

未报告次要终点

研究者

申办方类型
Government medical college

研究点 (1)

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