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临床试验/NCT03496740
NCT03496740已完成不适用

Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial

Kocaeli University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年4月15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
36
试验地点
1
主要终点
Time to first analgesic

研究概览

简要总结

Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 10 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • 1 to 10 years of age
  • Undergoing elective hypospadias surgery

排除标准

  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • ASA III-IV
  • Patients with neurological disorders

研究组 & 干预措施

Pudendal Block

Active Comparator

Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

干预措施: Pudendal Block (Procedure)

Penile Block

Active Comparator

Ultrasound guided dorsal penile nerve block will be administered after general anesthesia.

0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

干预措施: Penile Block (Procedure)

Penile Block

Active Comparator

Ultrasound guided dorsal penile nerve block will be administered after general anesthesia.

0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

干预措施: Bupivacaine (Block Drug) (Drug)

Pudendal Block

Active Comparator

Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

干预措施: Bupivacaine (Block Drug) (Drug)

结局指标

主要结局

Time to first analgesic

时间窗: postoperative 7 day

First need for rescue analgesic after the surgery will be recorded

次要结局

  • Pain Scores(postoperative 48 hour)

研究者

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

Can AKSU

Assistant Professor

Kocaeli University

研究点 (1)

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