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临床试验/CTRI/2024/12/078491
CTRI/2024/12/078491尚未招募4 期

Comparison of Analgesic Efficacy of Ultrasound Guided Retrolaminar Block vs Caudal Block for Paediatric Patients Undergoing Open Inguinal Surgeries: A Non-Inferiority Randomised Controlled Trial

All India Institute of Medical Sciences, Patna1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年12月24日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Time to first rescue analgesia

研究概览

简要总结

Regional anaesthesia for inguinal surgeries in children has attracted increasing interest and different technique like like subarachnoid,caudal,epidural block,wound infiltration,ilioinguinal and paravertebral block have been used with varying success.

In Paediatric surgery caudal block is a low cost,simple and effective procedure for post operative analgesia.

Retrolaminar Block is one of the newer and simpler alternative technique to the traditional caudal block.Drug is deposited into the retrolaminar spacebetween the lamina of T12 and paraspinal muscle.

Caudal block is most common regional anaesthesia technique used for inguinal surgeries in paediatric patients. Caudal block is not free of complications and can include side effects and complications like hypotension,motor blockage,urinary retension,subdural,intravascular or intraosseus injections of the drug,injury to nerve roots and spinal cord infections etc.Retrolaminar block in other hand is less invasive and the target is away from neuroaxis,rendering it potentially safe.

Through this study,we are trying to explorean alternative regional anaesthesia technique that is less invasive with non-inferior analgesic benefit compared to Caudal block.

No RCT has been conducted till date comparing Retrolaminar Block to Caudal block in paediatric patients.

We expect that Retrolaminar Block will provide analgesia non inferior to Caudal block in Paediatric patients undergoing inguinal surgeries.This will help us to inculcate this block as routine practice in our setup in this subset of patients.

研究设计

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

入排标准

年龄范围
1.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • Age 1-6years ASA I and II patients scheduled for inguinal surgeries.

排除标准

  • Patients with coagulation disorders Patients hypertensive to study medications Patients with developmental or mental delay Skin lesions or infection at the planned site of needle insertion Congenital vertebral anomalies.

结局指标

主要结局

Time to first rescue analgesia

时间窗: assessment within 24 hours post surgery estimated at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours.

次要结局

  • Intraoperative fentanyl use(Number of patients requiring rescue analgesia in 24hours/till the time of discharge)

研究者

发起方
All India Institute of Medical Sciences, Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Suman Das

AIIMS Patna

研究点 (1)

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