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临床试验/NCT06500286
NCT06500286尚未招募1 期

Comparison Between Dorsal Nerve Block and Caudal Block Effect in Post Operative Pain in Hypospedius Repair in Children

Assiut University0 个研究点目标入组 103 人开始时间: 2024年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
入组人数
103
主要终点
Efficacy of dorsal penile block

研究概览

简要总结

Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial

详细描述

• Group A receive caudal block placing the patient into the left lateral decubitus position. Povidone iodine was used to sterilize the skin. The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal membrane by using the loss of resistance method, the caudal epidural space was entered. Negative aspiration was used to make sure there was no blood or cerebrospinal fluid present and 0.25% bupivacaine was administered at a dose of 0.2 ml/kg. Once the procedure was completed, the patient was placed into the supine Position.

Group B US guided Dorsal penil block. General anesthesia induction was followed by skin sterilization using 70% alcohol in 2% chlorhexidine. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis.

研究设计

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

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • aged 2-12 years
  • ASA physical status I or II

排除标准

  • asthmatic patients
  • emergency surgery
  • intellectual disability
  • neurological diseases with agitation-like symptoms
  • renal or hepatic disease,
  • cardiac or respiratory disease
  • allergy to the study drugs
  • parent refusal
  • psychiatric diseases

研究组 & 干预措施

Group A

Experimental

• Group A receive caudal block placing the patient into the left lateral decubitus position. . The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal 0.25% bupivacaine was administered at a dose of 0.2 ml/kg.the procedure was completed, the patient was placed into the supine Position.

干预措施: Marciane (Drug)

Group B

Experimental

Group B US guided Dorsal penil block. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis.

干预措施: Marcaine (Drug)

结局指标

主要结局

Efficacy of dorsal penile block

时间窗: 1year

Score of pain visual Analougue Score

次要结局

  • Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block(1year)

研究者

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

Soha Abd Elhamid Fawzy

Resident doctor in assiut university hospitals

Assiut University

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