DPNB vs. Modified DPNB With Ventromedial Infiltration (DPNB According to Dalens' Technique)
Primary Purpose
Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Performing dorsal penile nerve block (DPNB)
Sponsored by
About this trial
This is an interventional treatment trial for Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia
Eligibility 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
Sites / Locations
- Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dorsal penile nerve block according to Dalens' technique
DPNB with additional infiltration of the ventromedial penis
Arm Description
Two injections at the dorsum penis according to Dalens' technique.
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.
Outcomes
Primary Outcome Measures
Need for opioid analgesics
Secondary Outcome Measures
Need for analgesics
Pain
Incidence and severity of pain
Hospital length of stay
Length of stay within post-anesthesia recovery unit
Postoperative complications and infections
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01974011
Brief Title
DPNB vs. Modified DPNB With Ventromedial Infiltration (DPNB According to Dalens' Technique)
Official Title
Comparison of Dorsal Penile Nerve Block (DPNB According to Dalens' Technique) to Dorsale Penile Nerve Block With Ventromedial Infiltration
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 25, 2013 (Actual)
Primary Completion Date
January 5, 2016 (Actual)
Study Completion Date
January 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Claudia Spies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dorsal penile nerve block according to Dalens' technique
Arm Type
Experimental
Arm Description
Two injections at the dorsum penis according to Dalens' technique.
Arm Title
DPNB with additional infiltration of the ventromedial penis
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Performing dorsal penile nerve block (DPNB)
Primary Outcome Measure Information:
Title
Need for opioid analgesics
Time Frame
On the day of surgery
Secondary Outcome Measure Information:
Title
Need for analgesics
Time Frame
Perioperatively up to the seventh postoperative day
Title
Pain
Description
Incidence and severity of pain
Time Frame
perioperatively up to the seventh postoperative day
Title
Hospital length of stay
Time Frame
Up to hospital discharge, an exspected average of one day
Title
Length of stay within post-anesthesia recovery unit
Time Frame
Up to post-anesthesia recovery unit discharge, an exspected average of six hours
Title
Postoperative complications and infections
Time Frame
Perioperatively up to the seventh postoperative day
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD, Prof.
Organizational Affiliation
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
2742166
Citation
Dalens B, Vanneuville G, Dechelotte P. Penile block via the subpubic space in 100 children. Anesth Analg. 1989 Jul;69(1):41-5.
Results Reference
background
PubMed Identifier
19889061
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.
Results Reference
background
PubMed Identifier
8010422
Citation
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.
Results Reference
background
PubMed Identifier
8528302
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. doi: 10.1007/BF00182973.
Results Reference
background
PubMed Identifier
7867113
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. doi: 10.1007/BF03020658.
Results Reference
background
PubMed Identifier
15674514
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. doi: 10.1007/s00540-004-0287-8.
Results Reference
background
PubMed Identifier
14511049
Citation
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.
Results Reference
background
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DPNB vs. Modified DPNB With Ventromedial Infiltration (DPNB According to Dalens' Technique)
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