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临床试验/NCT06545058
NCT06545058已完成不适用

Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision: a Large Cohort Study in Children

Universitair Ziekenhuis Brussel0 个研究点目标入组 2,086 人开始时间: 2000年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,086
主要终点
Safety profile of Ropivacaine

研究概览

简要总结

Dorsal penile nerve block (DPNB) according to Dalens' technique by using local anesthetics (LAs) is a fundamental part of a multimodal analgesic approach following circumcision. Ropivacaine has a favorable cardiovascular and neurological toxicity profile. However, its application in DPNB is limited because of the theoretical concerns about its vasoconstrictive properties and the potential risks of ischemia of the glans. The aim is to evaluate the incidence of necrosis of the glans penis and the safety profile of ropivacaine following its use in the DPNB in a large pediatric population.

详细描述

Circumcision is one of the most practiced surgical procedures in childhood causing significant postoperative pain in the infant. Perioperative and postoperative pain management at this age ideally should be managed by a combination of general anesthesia with regional anesthesia techniques such as caudal block, dorsal penile nerve block or subcutaneous ring block of the penis.

The dorsal nerves of the penis can be anesthetized at the level of the penile root through different approaches. Kirya and Wertgmann described for the first time dorsal penile nerve block. Since then, many studies have been realized and have been showed its benefits and safety in the clinical use.

Ring Blok is also known for its safety and low incidence of complications and has been used primarily for postoperative pain management in circumcision. This block is easy to perform but it has been identified that it has a greater failure compared to the dorsal penile block. In the study of Holder who compares dorsal penile block and ring block, most of the children who has had a ring block also received opioids postoperatively.

Implementation of local or regional anesthesia techniques is inevitably associated with risks and complications. For DPNB, this is estimated around 0.18%. Those complications may include urethral injuries, accidental injection of an incorrect drug or drug dose, accidental intravascular injection of local anesthetics, ischial osteomyelitis, hematoma, and ischemia and necrosis of the glans penis. The dorsal nerves of the penis also lies close to de corpora cavernosa and the Buck's fascia. Given the rich vascularized features of these structure, DNPB may increase the risk of intravascular injection, systemic absorption of local anesthetics or hematoma.

Ischemia or even necrosis of the glans due to the placement of a penile block is a very rare complication that is not seen in the daily practice. Endothelial injury and necrosis is a serious complication that can be caused due to vascular compression because of the mass effect of anesthetic solution or hematoma, perforation of a vein or artery, excessive cauterization, a very tight suture, veno/vasospasm at the glans; secondary to surgery or the dorsal penile nerve block.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 16 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • All male children aged up to 16 years
  • All circumcision made at UZ Brussel
  • All revision of circumcision made at UZ Brussel
  • All procedures between 1 January 2000 and 31 December 2021
  • All type ASA
  • Penile Block performed by anesthesiologist
  • All Penile Block performed with local anesthetics at diverse concentrations

排除标准

  • Canceled procedure
  • Missing anesthetic records
  • Children who received caudal block by anesthesiologist in charge
  • Children who received local infiltration of local anesthetics by the surgeon

结局指标

主要结局

Safety profile of Ropivacaine

时间窗: During time of surgery

To evaluate the safety profile of ropivacaine following its use in the Dorsal penile nerve block in a large pediatric population.

Incidence of necrosis of the glans penis

时间窗: During time of surgery

To evaluate the incidence of necrosis of the glans penis following the use of ropivacaine in the Dorsal penile nerve block in a large pediatric population.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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