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

Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974011
• Other study ID #: DPNB vs. Modified DPNB
• Status: Completed
• Phase: N/A
• Start date: November 25, 2013
• Est. completion date: January 6, 2016

Study information

• Verified date: February 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 6, 2016
• Est. primary completion date: January 5, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 1 Year to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia
• Hypospadias

Intervention

Procedure:
• Performing dorsal penile nerve block (DPNB)

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Claudia Spies

Country where clinical trial is conducted

Germany, 

References & Publications (7)

Dalens B, Vanneuville G, Dechelotte P. Penile block via the subpubic space in 100 children. Anesth Analg. 1989 Jul;69(1):41-5. — View Citation

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. — View Citation

Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Yucel S, Baskin LS. Neuroanatomy of the male urethra and perineum. BJU Int. 2003 Oct;92(6):624-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for opioid analgesics		On the day of surgery
Secondary	Need for analgesics		Perioperatively up to the seventh postoperative day
Secondary	Pain	Incidence and severity of pain	perioperatively up to the seventh postoperative day
Secondary	Hospital length of stay		Up to hospital discharge, an exspected average of one day
Secondary	Length of stay within post-anesthesia recovery unit		Up to post-anesthesia recovery unit discharge, an exspected average of six hours
Secondary	Postoperative complications and infections		Perioperatively up to the seventh postoperative day