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临床试验/CTRI/2019/02/017421
CTRI/2019/02/017421已完成不适用

A RANDOMIZED CONTROLLED TRIAL COMPARING ULTRASOUND GUIDED VERSUS CONVENTIONAL INJECTION FOR CAUDAL BLOCK IN CHILDREN UNDERGOING INFRA UMBILICAL SURGERIES

Sri Ramachandra University1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2019年12月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
First puncture success rate

研究概览

简要总结

·       Regional anaesthetic techniques are known to  reduce the post-operative morbidity, provide early mobilisation and reduce opioid requirements. Caudal epidural block is a widely used regional anaesthetic technique especially in paediatric surgery to provide intraoperative and post-operative analgesia in surgeries below umbilical level(T10-S5 dermatomes). Conventional single shot caudal block technique involves the risk of dural or vascular puncture, intra osseous injection, soft tissue bulging and systemic toxicity. Many anatomic variations have been reported for sacral hiatus and sacral cornua. Therefore, success rate of classic caudal epidural technique has been reported to be about 75%. Ultrasonography is helpful for visualisation of the sacral hiatus, sacrococcygeal ligament, duramater, epidural space and distribution of local anaesthetic agent within the epidural space therefore significantly increases the block success rate. Indian data on caudal epidural block has been scarce and world over, the number of studies on ultrasound guided caudal epidural block is minimal. Hence we wish to conduct a randomised control study comparing ultrasound guided caudal block versus conventional caudal block in children undergoing elective infraumbilical surgeries. The primary outcome would be the first puncture success rate comparing both the arms. Other outcomes such as  block performing time, success of the block and complications would also be assessed. The study would be conducted over a period of 6 months in the department of anaesthesia at a tertiary care centre hospital in southern India.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant Blinded

入排标准

年龄范围
6.00 Month(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • patients undergoing elective infra-umbilical surgeries with ASA physical status I and II.

排除标准

  • ASA physical status III and above Emergency surgeries Infection at the site of caudal injection Sacral bone abnormalities Bleeding disorders Allergy to local anaesthetics.

结局指标

主要结局

First puncture success rate

时间窗: Reaching sacral canal or sacral hiatus with a single needle orientation on 1st puncture without withdrawal from skin.

次要结局

  • Block performing time(Time from needle insertion to termination of local anaesthetic administration)
  • Successful block(Defined as absence of limb movements and no increase in heart rate or mean arterial pressure above 15% from baseline on skin incision)
  • Complications(if any)(Vascular puncture, subcutaneous tissue bulging,Dural puncture and local anaesthetic toxicity)

研究者

发起方
Sri Ramachandra University
申办方类型
Research institution and hospital

研究点 (1)

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