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临床试验/NCT03482947
NCT03482947已完成不适用

TAP vs Caudal Block Using Dexmedetomidine/Bupivacaine Combination for Postoperative Analgesia in Pediatric Patients Undergoing Unilateral Inguinal Hernia Repair

Assiut University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Postoperative analgesia.

研究概览

简要总结

Caudal epidural block is a well-established and commonly performed regional neuraxial technique for providing intraoperative and postoperative analgesia in children scheduled for lower abdomen/perineal surgical interventions. Although the efficacy and safety of Caudal epidural block are fairly high, the associated complications, such as inadvertent dural puncture, unwarranted motor blockade of the lower limbs, and disturbance of bladder function, limit its use. Furthermore, a major limitation of an uncomplicated Caudal epidural block when administered as a "single-shot" technique is its brief duration of action (up to 6 hours), which makes administration of additional analgesics necessary .

详细描述

Ultrasonography guidance, by virtue of real-time visualization of the muscle layers and fascial planes, has significantly facilitated practice of regional nerve blockade for it offers confirmation of the spread of the local anesthetic drug in the correct space. Interestingly, there has been a reinvigoration of interest in ultrasonography-guided transversus abdominis plane block in children since its emergence as a valid postoperative analgesia alternative in adults undergoing abdominal surgery. transversus abdominis plane block involves blockade of spinal afferent nerves in the neurofascial plane between the internal oblique and transversus abdominis muscle. Whereas the advantages (reduction in pain intensity/analgesic requirements) of ultrasonography-guided transversus abdominis plane block have been well documented in adults in the first 48 hours post surgery, in children, its use as a primary postoperative analgesia technique remains limited. Caudal anesthesia is easy to perform in younger children; however, its main disadvantage is the short duration of action. Even bupivacaine, along-acting local anesthetic drug, can provide only4-8 h of analgesia. Dexmedetomidine is a highly selective alfa2 agonist with sedative and analgesic properties. It has an alfa1/2 selectivity ratio of 1600 : 1, which is eight times more potent than clonidine (200 : 1)[16]. DEX has been used effectively in intensive care to aid weaning from mechanical ventilation and is being used increasingly 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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
2 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients 2-8 years

排除标准

  • 未提供

研究组 & 干预措施

Caudal

Experimental

Caudal epidural block administration of (1 mL/kg of bupivacaine 0.25% &1 μ/kg dexmedetomidine

干预措施: Caudal epidural block (Drug)

TAP

Experimental

ultrasonography-guided transversus abdominis plane block administration of (1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).

干预措施: ultrasonography-guided TAP block (Drug)

结局指标

主要结局

Postoperative analgesia.

时间窗: 24 hours

time for first analgesic request

次要结局

  • Postoperative analgesia(24 hours)
  • Postoperative pain(24 hours)

研究者

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

Ghada Mohammed AboelFadl

MD

Assiut University

研究点 (1)

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