跳至主要内容
临床试验/CTRI/2025/03/083164
CTRI/2025/03/083164尚未招募2 期

Evaluation of analgesic effect of continous caudal epidural levobupivacaine and ropivacaine in Infraumbilical paediatric surgeries

Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月24日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To study the analgesic effect and to compare the duration of postoperative pain relief achieved in continuous caudal epidural in infraumbilical pediatric surgeries

研究概览

简要总结

Caudal Epidural Anaesthesia will be administered under sedation with Ketamine or Midazolam in standard dose as per requirement of surgery. The patient will be positioned in the left lateral and under full aseptic precautions; a sterile 22 gauge needle will be introduced in the caudal epidural space. After confirming the position of the needle with Loss of resistance technique the allocated drug will be given slowly over 60sec. Epidural Catheter will be inserted and secured in caudal space. Intraoperatively bolus dose of levobupivacaine or ropivacaine will be administered. After 15 minutes infusion will be started. Then, the patient will be turned to supine position; anesthesia will be maintained with Midazolam/Ketamine and oxygen will be connected.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
30.00 Day(s) 至 4.00 Year(s)(—)
性别
All

入选标准

  • Either sex of age 30 days to 4 years undergoing infraumbilical surgeries.
  • ASA Grades I and II.

排除标准

  • Patients/Parent refusal Coagulation abnormalities/bleeding diathesis ASA Grades III and IV Patients having a history of significant neurological,psychiatric,neuromuscular disorders Any cardiac disease History of allergic reactions to local anaestheic agents.

结局指标

主要结局

To study the analgesic effect and to compare the duration of postoperative pain relief achieved in continuous caudal epidural in infraumbilical pediatric surgeries

时间窗: Assessment of post operative pain after completion of surgery at 2,4,6 hr after surgery and thereafter 6 hourly till 24 hours after surgery

次要结局

  • To asess the requirement of any add on analgesia in post operative period(Assessment of post operative pain after completion of surgery at 2,4,6 hr after surgery and thereafter 6 hourly till 24 hours after surgery)

研究者

发起方
Gandhi Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Rohit Raman

Gandhi Medical College

研究点 (1)

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