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临床试验/CTRI/2025/09/094533
CTRI/2025/09/094533尚未招募不适用

To compare injection bupivacaine(0.75mg/kg) and injection bupivacaine (0.5mg/kg)+ injection lignocaine (2mg/kg) in transversus abdominis plane block for postoperative analgesia in infants undergoing abdominal surgery.

Sapthagiri Institute of Medical Science and Research Center1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年9月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
54
试验地点
1
主要终点
postoperative analgesia using Neonatal Infant Pain Scale (NIPS) and total rescue analgesic requirement within 24 hours after surgery.

研究概览

简要总结

A prospective randomized controlled study comparing injection bupivacaine 0.75 mg per kg with injection bupivacaine 0.5 mg per kg plus injection lignocaine 2 mg per kg for postoperative analgesia in surgeon-administered Transversus Abdominis Plane block in infants undergoing abdominal surgery.

.The primary outcome is to compare postoperative pain scores using NIPS and total rescue analgesic requirement within 24 hours. This trial is registered to promote safe and effective pain management strategies in infants undergoing surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
1.00 Day(s) 至 12.00 Month(s)(—)
性别
All

入选标准

  • Infants aged from birth to 12 months undergoing abdominal surgery.
  • ASA physical status I and II.
  • Parents or guardians willing to provide informed written consent.

排除标准

  • Local infection at the block site.
  • Known hypersensitivity or allergy to bupivacaine or lignocaine.

结局指标

主要结局

postoperative analgesia using Neonatal Infant Pain Scale (NIPS) and total rescue analgesic requirement within 24 hours after surgery.

时间窗: 24hours

次要结局

未报告次要终点

研究者

发起方
Sapthagiri Institute of Medical Science and Research Center
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shreya M S

Sapthagiri Institute Of Medical Sciences And Research Centre

研究点 (1)

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