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

NCT01974011 | Completed

• 1 other identifier: DPNB vs. Modified DPNB
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia

Outcome Measures

Primary Outcomes (1)

• Need for opioid analgesics

  On the day of surgery

Secondary Outcomes (5)

• Need for analgesics

  Perioperatively up to the seventh postoperative day

• 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

Study Arms (2)

Dorsal penile nerve block according to Dalens' technique

EXPERIMENTAL

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

Procedure: Performing dorsal penile nerve block (DPNB)

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.

Procedure: Performing dorsal penile nerve block (DPNB)

Interventions

Performing dorsal penile nerve block (DPNB) PROCEDURE

DPNB with additional infiltration of the ventromedial penis; Dorsal penile nerve block according to Dalens' technique

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Related 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.

  PMID: 2742166 BACKGROUND

• 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.

  PMID: 19889061 BACKGROUND

• 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.

  PMID: 8010422 BACKGROUND

• 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.

  PMID: 8528302 BACKGROUND

• 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.

  PMID: 7867113 BACKGROUND

• 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.

  PMID: 15674514 BACKGROUND

• 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.

  PMID: 14511049 BACKGROUND

Study Officials

• Claudia Spies, MD, Prof.

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care - Medicine CVK/CCM

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 1, 2013
• Study Start: November 25, 2013
• Primary Completion: January 5, 2016
• Study Completion: January 6, 2016
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

DE (1)