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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01974011
First received: October 28, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia
Procedure: Performing dorsal penile nerve block (DPNB)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Dorsal Penile Nerve Block (DPNB According to Dalens' Technique) to Dorsale Penile Nerve Block With Ventromedial Infiltration

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Need for opioid analgesics [ Time Frame: On the day of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Need for analgesics [ Time Frame: Perioperatively up to the seventh postoperative day ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: perioperatively up to the seventh postoperative day ] [ Designated as safety issue: No ]
    Incidence and severity of pain

  • Hospital length of stay [ Time Frame: Up to hospital discharge, an exspected average of one day ] [ Designated as safety issue: No ]
  • Length of stay within post-anesthesia recovery unit [ Time Frame: Up to post-anesthesia recovery unit discharge, an exspected average of six hours ] [ Designated as safety issue: No ]
  • Postoperative complications and infections [ Time Frame: Perioperatively up to the seventh postoperative day ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974011

Contacts
Contact: Claudia Spies, MD, Prof. +49 30 450 551001 claudia.spies@charite.de

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin Recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, MD Prof.    +49 30 450 551001    claudia.spies@charite.de   
Principal Investigator: Claudia Spies, MD, Prof.         
Sub-Investigator: Lutz Müller-Lobeck, MD         
Sub-Investigator: Sylvia Kramer, MD, DESA         
Sponsors and Collaborators
Claudia Spies
Investigators
Study Director: Claudia Spies, MD, Prof. Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
  More Information

Publications:
Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care - Medicine CVK/CCM, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01974011     History of Changes
Other Study ID Numbers: DPNB vs. Modified DPNB
Study First Received: October 28, 2013
Last Updated: May 14, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014