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临床试验/NCT06561269
NCT06561269已完成不适用

Ultrasound_guided Multifidus Plane Block Versus Ultrasound_guided Caudal Block for Pediatric Hypospadias Surgery: a Randomized Controlled Clinical Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
is to measure the first time to rescue analgesia postoperative (24 hours).

研究概览

简要总结

This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia

详细描述

Peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. The usage of regional anesthesia in association with general anesthesia (GA) is a simple intraoperative way that reduces (GA) requirements and side effects. Recently, paraspinal fascial plane block, the sacral multifidus plane block (MPB), was used successfully in infants. The study has been designed to determine the effect of MPB versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • ⦁ Children aged (1 -7) years old.
  • All patients will be of ASA classification I, II physical status

排除标准

  • ⦁ Parents refusing to participate are excluded from the trial.
  • Children who had spinal anomalies, altered mental status.
  • A history of developmental delay.
  • Blood diseases: Coagulopathy or anaemia.
  • Infection at the site of injection.
  • Drug allergy.

研究组 & 干预措施

Multifidus plane block (MPB) group

Experimental

Participants will be injected bupivacaine at the fascial plane between the multifidus muscle and the median sacral crests of S2 and S3

干预措施: Multifidus plane block (Procedure)

Caudal block (CB) group

Experimental

Participants will be injected by bupivacaine, between the two sacral cornua

干预措施: caudal block (Procedure)

结局指标

主要结局

is to measure the first time to rescue analgesia postoperative (24 hours).

时间窗: 24 hours postoperative

Measure the first time to rescue analgesia post operative

次要结局

  • Heart rate(start to end of surgery)
  • Blood pressure(start to end of the surgery.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Radwa Tarek

Dr.

Ain Shams University

研究点 (1)

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