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临床试验/CTRI/2025/06/089644
CTRI/2025/06/089644招募中3 期

Comparison of ultrasound-guided sacral multifidus plane block versus caudal epidural block (CEB) for analgesia in children undergoing penile surgery: a randomized controlled study.

AIIMS, Bhubaneswar1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年7月7日最近更新:

试验速览

阶段
3 期
状态
招募中
入组人数
68
试验地点
1
主要终点
To identify, the time to first rescue analgesia measured from the end to surgery till first dose of analgesics administrated in paediatric patient measured with Modified Objective Pain Scale (MOPS). The adequate pain control is defined as MOPS score less than or equal to 4 after surgery

研究概览

简要总结

The sacral multifidus plane (SMPB) blockis a regional block that targets both the dorsal and ventral roots of the spinal nerve, offering analgesia for both somatic and visceral pain. This technique facilitates the extensive distribution of local anaesthetics in a craniocaudal direction, effectively blocking multiple dermatomes From S1-S4. [4] Recently, some case reports suggested that the sacral multifidus plane block, was found to be an effective technique for providing postoperative pain relief in patients undergoing hypospadias surgery.

Hence, we hypothesize that the sacral multifidus plane block may provide equivalent analgesia compared to CEB in penile surgery.

研究设计

研究类型
Interventional

入排标准

年龄范围
3.00 Year(s) 至 12.00 Year(s)(—)
性别
Male

入选标准

  • ASA grade I and II patients
  • Male children aged between 3-12 years of age scheduled for hypospadias repair.

排除标准

  • Children with a bleeding disorder
  • Redo urethroplasty
  • Contraindication to CEB
  • Vertebral column anomaly
  • Neurological disorders
  • Refusal of the parents for regional blocks.

结局指标

主要结局

To identify, the time to first rescue analgesia measured from the end to surgery till first dose of analgesics administrated in paediatric patient measured with Modified Objective Pain Scale (MOPS). The adequate pain control is defined as MOPS score less than or equal to 4 after surgery

时间窗: the time to first rescue analgesia measured from the end to surgery till first dose of analgesics

次要结局

  • • Intraoperative haemodynamic parameters (heart rate, MAP) between groups.(• Modified Objective Pain Scale (MOPS) on arrival in post anaesthesia care unit at 1, 2, and 6 hours after surgery.)

研究者

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

Dr Alok Kumar Sahoo

AIIMS, Bhubaneswar

研究点 (1)

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