DPNB vs. Modified DPNB With Ventromedial Infiltration (DPNB According to Dalens' Technique)

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

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.

Study Overview

• Status: Completed
• Conditions: Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia
• Intervention / Treatment: Procedure: Performing dorsal penile nerve block (DPNB)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dorsal penile nerve block according to Dalens' technique; Two injections at the dorsum penis according to Dalens' technique.	Procedure: Performing dorsal penile nerve block (DPNB)
Active Comparator: DPNB with additional infiltration of the ventromedial penis; 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.	Procedure: Performing dorsal penile nerve block (DPNB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Need for opioid analgesics	On the day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for analgesics		Perioperatively up to the seventh postoperative day
Pain	Incidence and severity of pain	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
Postoperative complications and infections		Perioperatively up to the seventh postoperative day

Collaborators and Investigators

• Sponsor: Claudia Spies
• Investigators: Study Director: Claudia Spies, MD, Prof., Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Publications and helpful links

General Publications

• Dalens B, Vanneuville G, Dechelotte P. Penile block via the subpubic space in 100 children. Anesth Analg. 1989 Jul;69(1):41-5.
• Long RM, McCartan D, Cullen I, Harmon D, Flood HD. A preliminary study of the sensory distribution of the penile dorsal and ventral nerves: implications for effective penile block for circumcision. BJU Int. 2010 Jun;105(11):1576-8. doi: 10.1111/j.1464-410X.2009.09044.x. Epub 2009 Nov 4.
• Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. doi: 10.1213/00000539-199407000-00024.
• Stav A, Gur L, Gorelik U, Ovadia L, Isaakovich B, Sternberg A. Modification of the penile block. World J Urol. 1995;13(4):251-3. doi: 10.1007/BF00182973.
• Szmuk P, Ezri T, Ben Hur H, Caspi B, Priscu L, Priscu V. Regional anaesthesia for circumcision in adults: a comparative study. Can J Anaesth. 1994 Dec;41(12):1181-4. doi: 10.1007/BF03020658.
• Weksler N, Atias I, Klein M, Rosenztsveig V, Ovadia L, Gurman GM. Is penile block better than caudal epidural block for postcircumcision analgesia? J Anesth. 2005;19(1):36-9. doi: 10.1007/s00540-004-0287-8.
• Yucel S, Baskin LS. Neuroanatomy of the male urethra and perineum. BJU Int. 2003 Oct;92(6):624-30. doi: 10.1046/j.1464-410x.2003.04435.x.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2013
• Primary Completion (Actual): January 5, 2016
• Study Completion (Actual): January 6, 2016

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: October 28, 2013
• First Posted (Estimate): November 1, 2013

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Hypospadias
• Other Study ID Numbers: DPNB vs. Modified DPNB