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临床试验/CTRI/2025/08/093685
CTRI/2025/08/093685尚未招募3 期

Comparison of sacral erector spinae plane block with caudal block for post-operative analgesia in paediatric patients undergoing penoscrotal surgery.

Vardhman Mahavir Medical college and Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare duration of analgesia (time to first rescue analgesia) in Sacral erector spinae plane

研究概览

简要总结

This study will compare two different anaesthesia techniques, the sacral erector spinae plane block and the caudal block  for controlling pain after genital surgery in children. Children undergoing surgery for conditions like hypospadias or circumcision under general anaesthesia will be randomly assigned to receive one of these blocks. Pain scores, duration of pain relief, and the amount of additional pain medicine needed in the first 24 hours after surgery will be recorded and compared between the two groups.

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 7.00 Year(s)(—)
性别
Male

入选标准

  • Paediatric male patients, aged 1–7 years, with American Society of Anesthesiologists (ASA) physical status I or II, scheduled to undergo elective penoscrotal surgery under general anaesthesia.

排除标准

  • Patients with spinal anomalies, altered mental status, history of developmental delay
  • Infection at the site of injection
  • Documented allergy to local anaesthetic agents
  • Additional surgical procedures at different surgical sites.

结局指标

主要结局

To compare duration of analgesia (time to first rescue analgesia) in Sacral erector spinae plane

时间窗: From completion of block until first administration of rescue analgesia within 24 hours postoperatively.

block group and Caudal block group in paediatric patients undergoing penoscrotal surgery

时间窗: From completion of block until first administration of rescue analgesia within 24 hours postoperatively.

under general anaesthesia.

时间窗: From completion of block until first administration of rescue analgesia within 24 hours postoperatively.

次要结局

  • Postoperative pain scores using FLACC scale(At 0h(Immediate postoperative period),1h, 2h, 4h, 6h, 12h and 24h.)
  • Total postoperative oral Ibuprofen Consumption(mg) in 24 hours(Cumulative dose from 0-24 hours postoperatively)

研究者

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

Prasanth R

Vardhman Mahavir Medical college and Safdarjung Hospital

研究点 (1)

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