跳至主要内容
临床试验/CTRI/2024/07/071128
CTRI/2024/07/071128尚未招募Unknown

Comparison of caudal bupivacaine alone and caudal bupivacaine- dexamethasone combination for pediatric patients undergoing elective infraumbilical surgery

Vardhman Mahavir medical college and Safdarjung hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
To compare the duration of postoperative analgesia in caudal block using bupivacaine and bupivacaine with dexamethasone by time taken to first rescue analgesia in paediatric patients undergoing elective infraumbilical surgery

研究概览

简要总结

This study is a randomised comparative study to compare the postoperative analgesia between caudal bupivacaine alone and caudal bupivacaIne-dexamethasone in pediatric patients undergoing elective infraumbilical surgery under general anaesthesia, with the hypothesis that the bupivacaine-dexamethasone combination provides better postoperative analgesia than bupivacaine alone in caudal block. Primarily postoperative pain scores (FLACC score) will be recorded at 0hr, 1hr, 2hrs, 4hrs, 8hrs, 12hrs and 24 hrs. Secondarily intraoperative hemodynamic parameters and total analgesic requirement in 24 hrs will be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • All patients aged 2-10 years with American society of Anesthesiologists physical status I, II scheduled for elective infraumbilical surgeries.

排除标准

  • 1.Infection at the site of the block.
  • 2.Coagulopathy.
  • 3.Allergy to local anesthetics.
  • 4.Pre-existing neurological or spinal disease and abnormalities of the sacrum.

结局指标

主要结局

To compare the duration of postoperative analgesia in caudal block using bupivacaine and bupivacaine with dexamethasone by time taken to first rescue analgesia in paediatric patients undergoing elective infraumbilical surgery

时间窗: To compare the duration of postoperative analgesia in caudal block using bupivacaine and bupivacaine with dexamethasone by time taken to first rescue analgesia in paediatric patients undergoing elective infraumbilical surgery

次要结局

  • 1. Intraoperative haemodynamic parameters.(2. Total analgesia requirement in the first 24 hours.)

研究者

发起方
Vardhman Mahavir medical college and Safdarjung hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Bharath T

Department of Anesthesia and Intensive Care

研究点 (1)

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