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临床试验/CTRI/2025/10/096515
CTRI/2025/10/096515尚未招募2/3 期

A randomized controlled study to compare effectiveness of Erector spinae plane block versus caudal block for postoperative analgesia in pediatric inguinal hernia surgery under general anesthesia

Department of anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年11月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
105
试验地点
1
主要终点
Mean FLACC pain score in first 24 hrs

研究概览

简要总结

Inguinal herniotomy is a commonly performed day care procedure in pediatric patients and post operative analgesia is crucial for peri operative care. Failure to adequately control post operative pain can lead to negative behavioral changes and parental dissatisfaction.

Caudal block is the gold standard for pain management in children undergoing lower abdominal surgeries due to its enhanced reliability and safety profile. However a notable drawback of this technique is its limited duration of action following single injection. Thus several interfacial plane blocks have been suggested as alternatives for postoperative analgesia in children including quadratus lumborum block, transverse abdominis plane block,rectus sheath block and Erector spinae plane block

The USG guided Erector spinae plane block is gaining popularity in pediatrics due to its potential for managing post operative pain in various surgeries as it is relatively easy to perform with no complications.

We plan to conduct this double blind randomised controlled study to compare the effectiveness of Erector spinae plane block versus Caudal block for post-operative analgesia in children undergoing inguinal hernia repair.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

年龄范围
2.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

  • Children undergoing elective unilateral hernia repair Patients belonging to ASA grade I and II Children of either sex children of 10 to 25 kg body weight Guardian willing to give consent.

排除标准

  • Children with a history of allergy to local anaesthetics Children undergoing bilateral inguinal hernia surgeries Local infection at the proposed site of block Children with bleeding or coagulation disorders Children with anatomical abnormalities of the spine.

结局指标

主要结局

Mean FLACC pain score in first 24 hrs

时间窗: 30 minutes | 1 hour | 2 hours | 4 hours | 6 hours | 8 hours | 12 hours | 24 hours

Mean Time to first rescue analgesia

时间窗: 30 minutes | 1 hour | 2 hours | 4 hours | 6 hours | 8 hours | 12 hours | 24 hours

Mean number of rescue analgesia in first 24 hours

时间窗: 30 minutes | 1 hour | 2 hours | 4 hours | 6 hours | 8 hours | 12 hours | 24 hours

Mean change in hemodyanamic parameters

时间窗: 30 minutes | 1 hour | 2 hours | 4 hours | 6 hours | 8 hours | 12 hours | 24 hours

Side effects if any

时间窗: 30 minutes | 1 hour | 2 hours | 4 hours | 6 hours | 8 hours | 12 hours | 24 hours

次要结局

未报告次要终点

研究者

发起方
Department of anaesthesiology SMS MEDICAL COLLEGE AND HOSPITAL
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Neelam Dogra

SMS MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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