跳至主要内容
临床试验/NCT01974011
NCT01974011已完成不适用

Comparison of Dorsal Penile Nerve Block (DPNB According to Dalens' Technique) to Dorsale Penile Nerve Block With Ventromedial Infiltration

Claudia Spies2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2013年11月25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
发起方
Claudia Spies
入组人数
86
试验地点
2
主要终点
Need for opioid analgesics

研究概览

简要总结

Dorsal penile nerve block (DPNB) is a regional nerve block probably most often performed throughout the world. There are several different methods described in the literature. When compared to penile ring wall infiltration or caudal block, the Dorsal penile nerve block (DPNB) is more likely associated with the risk of failure of the block quality. The aim of this study is to compare the quality of the standard method of Dorsal penile nerve block (DPNB)(Dalens' technique) with that of a modified procedure (Dorsal penile nerve block (DPNB)with additional infiltration of the ventromedial penis at the transition between the penis and the scrotum.

详细描述

Male circumcision is the most often performed operation in male children throughout the world. In the western world it is not accepted to perform this procedure without adequate analgesic support. Hence the dorsal penile nerve block (DPNB), first described in the 70ies of the 20th century, is one of the most frequently performed regional anesthetic procedures in both children and adults. There are several methods described in the literature, of which the one described by Dalens et al in 1989 nowadays is the most often quoted and most frequently performed method. The reported rate of insufficient analgesia by DPNB is higher than caudal block or penile ring wall infiltration. It is known from neuroanatomic studies, that the penis is innervated mostly, but not only by the dorsal penile nerve, a final branch of the pudendal nerve. A varying amount of the ventral penile skin, especially of the preputium and the frenulum, is innervated by fine end branches of the perineal nerve, which otherwise gives sensoric innervation to the scrotum and motor innervation to the bulbospongiosus muscle. An injection of local anesthetic underneath Buck's fascia is unable to reach the perineal nerve, which may be the explanation for these failures.

In this study we compare two different techniques of performing the dorsal penile nerve block (DPNB): the technique according to Dalens, and a modification, where a small amount of the local anesthetic for the dorsal penile nerve block (DPNB) is withheld, and then injected subcutaneously at the ventral transition between the penis and the scrotum in the midline. The latter injection at the site of perineal innervation is a relic of the penile ring wall infiltration, which surely blocks all skin fibres of both the dorsal penile nerve and the perineal nerve.

All patients included randomly receive either two injections at the dorsum penis according to Dalens' technique, or two injections at the dorsum penis according to Dalens' technique plus on subcutaneous injection in the ventral midline of the penis at the transition between the penis and the scrotum. The amount of local anesthetic (bupivacaine 0,75%, 0,2 ml/kg of body weight) and dosing of narcotics (Sevoflurane 2,2 Vol% end-expiratory gas in an oxygen-air mixture) is the same in both groups.

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
None

入排标准

年龄范围
1 Year 至 17 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Male infant
  • Aged 1-17 years
  • Elective surgery for circumcision, meatotomy or distal coronary correction of hypospadia

排除标准

  • Allergy to local anaesthetics
  • Congenital or acquired bleeding disorders
  • Neurological disease
  • Significant damage of central nervous system
  • Other malformation of urethra

研究组 & 干预措施

Dorsal penile nerve block according to Dalens' technique

Experimental

Two injections at the dorsum penis according to Dalens' technique.

干预措施: Performing dorsal penile nerve block (DPNB) (Procedure)

DPNB with additional infiltration of the ventromedial penis

Active Comparator

Modified procedure:

Two injections at the dorsum penis according to Dalens' technique plus on subcutaneous injection in the ventral midline of the penis at the transition between the penis and the scrotum.

干预措施: Performing dorsal penile nerve block (DPNB) (Procedure)

结局指标

主要结局

Need for opioid analgesics

时间窗: On the day of surgery

次要结局

  • Pain(perioperatively up to the seventh postoperative day)
  • Postoperative complications and infections(Perioperatively up to the seventh postoperative day)
  • Need for analgesics(Perioperatively up to the seventh postoperative day)
  • Hospital length of stay(Up to hospital discharge, an exspected average of one day)
  • Length of stay within post-anesthesia recovery unit(Up to post-anesthesia recovery unit discharge, an exspected average of six hours)

研究者

发起方
Claudia Spies
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Claudia Spies

Department of Anesthesiology and Intensive Care - Medicine CVK/CCM

Charite University, Berlin, Germany

研究点 (2)

Loading locations...

相似试验