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临床试验/CTRI/2024/08/072809
CTRI/2024/08/072809已完成3 期

Comparison of Analgesic Efficacy of Ultrasound Guided Sacral Erector Spinae Block vs Caudal Block for Paediatric Patients Undergoing Lower Limb Orthopaedic Surgery: A Randomised Controlled Trial

AIIMS Patna1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
To compare time to first rescue analgesia in sacral ESP block with caudal epidural block

研究概览

简要总结

The erector spinae plane block (ESPB) is an interfascial plane block, which appears to be increasing in popularity. Introduced in 2016, primarily to alleviate thoracic neuropathic pain, the indications for the block have been expanding since then.In pediatric surgery, caudal block is a low-cost, simple, and effective procedure for postoperative analgesia and as the only anaesthetic strategy . Caudal block is recommended for most surgical operations in the lower body, primarily below the umbilicus, including lower limb surgeries, inguinal hernia repair, urinary and digestive system surgery. Lower limb is supplied from nerve terminals arising from both sacral (sciatic L4-S3) and lumber (femoral (L2-L4) plexus. Erector spinae muscles overlay on the sacral lamina and continue over the transverse processes of lumbar vertebrae, thus a sacral ESP block performed with an adequate volume will spread in interfacial plane and through sacral foramina blocking both femoral and sciatic nerve, thus providing adequate analgesia for paediatric lower limb surgeries. Caudal block has been successfully used as a part of multimodal analgesic regime in surgeries in paediatric patients. There is a lack of comprehensive research on Sacral erector spinae block in paediatric patients. Effectiveness of sacral ESPB determined by our study will add to the existing body of scientific literature supporting its use as analgesic technique in current practice.No randomised controlled trial has been conducted till date comparing sacral ESPB block to caudal block in paediatric patients. We expect that sacral ESP block will provide analgesia noninferior to caudal block in paediatric patients undergoing lower limb surgeries.

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 8.00 Year(s)(—)
性别
All

入选标准

  • Age 1-8 years
  • ASA I and II patients scheduled for unilateral lower limb orthopaedic surgery.

排除标准

  • Parent refusal to participate in the study.
  • Patients with coagulation disorders.
  • Patients hypersensitive 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

To compare time to first rescue analgesia in sacral ESP block with caudal epidural block

时间窗: at 30 minutes,2,4,6,8,12 | and 24 hours

in paediatric lower limb orthopaedic surgery.

时间窗: at 30 minutes,2,4,6,8,12 | and 24 hours

次要结局

  • 1. To compare postoperative pain scores using the FLACC scale at 30 minutes,2,4,6,8,12(and 24 hours)

研究者

发起方
AIIMS Patna
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Vikram Chandra

AIIMS, patna

研究点 (1)

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