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临床试验/CTRI/2025/09/094973
CTRI/2025/09/094973尚未招募2 期

Comparison of Post Operative Analgesic Efficacy of Quadratus Lumborum Block With Bupivacaine of Same Dose and Different Concentrations in Paediatric Patients Undergoing Unilateral Open Inguinal Hernia Repair

VMMC and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年10月1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
76
试验地点
1
主要终点
To compare post operative analgesic efficacy of Quadratus lumborum block with bupivacaine

研究概览

简要总结

This study is a prospective, interventional trial designed to assess the effectiveness of ultrasound-guided Quadratus Lumborum Block (QLB) for postoperative pain relief in children aged 1 to 7 years undergoing unilateral open inguinal hernia surgery. The research compares two groups receiving the same total dose of bupivacaine (0.75 mg/kg) but at different concentrations and volumes: Group A receives 0.3 ml/kg of 0.25% bupivacaine, while Group B receives 0.6 ml/kg of 0.125% bupivacaine. The primary outcome is pain score measured using the CHEOPS scale at 6 hours post-surgery. Secondary outcomes include pain scores at additional time intervals, time to first rescue analgesia, total analgesic consumption over 24 hours, and intraoperative fentanyl usage. The goal is to determine whether a lower concentration with higher volume offers pain relief comparable to a higher concentration with lower volume, while remaining within safe limits for pediatric patients.

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
1.00 Year(s) 至 7.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 1 – 7 years with American Society of Anesthesiologists physical status I-II scheduled for unilateral open inguinal hernia surgery.

排除标准

  • EXCLUSION CRITERIA
  • Infection at the site of block
  • Coagulopathy
  • Pre-existing neurological disease
  • Allergy to local anesthetics.

结局指标

主要结局

To compare post operative analgesic efficacy of Quadratus lumborum block with bupivacaine

时间窗: CHEOPS score at 6 hours.

of same dose and different concentrations in paediatric patients undergoing open inguinal

时间窗: CHEOPS score at 6 hours.

hernia repair using the CHEOPS score at 6 hours.

时间窗: CHEOPS score at 6 hours.

次要结局

  • 1.To compare CHEOPS score at 0,3,8,18 and 24 hours.(2.To compare time to first rescue analgesia)

研究者

发起方
VMMC and Safdarjung Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Mayank Singh

VMMC and Safdarjung Hopital

研究点 (1)

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