Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006484

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006484
  •   2015/04/09
  •   2013/10/28
  •   yes
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Secondary IDs

  •   NCT01974011  (ClinicalTrials.gov)
  •   DPNB vs. Modified DPNB  (Claudia Spies)
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Health Condition or Problem studied

  •   Circumcision, Meatotomy or Distal Coronary Correction of Hypospadia
  •   N35 -  Urethral stricture
  •   Q54 -  Hypospadias
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Interventions/Observational Groups

  •   Procedure: Performing dorsal penile nerve block (DPNB)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

- Need for opioid analgesics; time frame: On the day of surgery

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Secondary Outcome

- Need for analgesics; time frame: Perioperatively up to the seventh postoperative day
- Pain; time frame: perioperatively up to the seventh postoperative day; Incidence and severity of pain
- Hospital length of stay; time frame: Up to hospital discharge, an exspected average of one day
- Length of stay within post-anesthesia recovery unit; time frame: Up to post-anesthesia recovery unit discharge, an exspected average of six hours
- Postoperative complications and infections; time frame: Perioperatively up to the seventh postoperative day

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/11/30
  •   60
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Inclusion Criteria

  •   Male
  •   1   Years
  •   17   Years
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Additional Inclusion Criteria

- Male infant

- Aged 1-17 years

- Elective surgery for circumcision, meatotomy or distal coronary correction of
hypospadia

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Exclusion Criteria

- Allergy to local anaesthetics

- Sepsis

- Congenital or acquired bleeding disorders

- Neurological disease

- Significant damage of central nervous system

- Other malformation of urethra

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Claudia Spies
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    • Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
    • Claudia Spies, MD, Prof. 
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  • start of 1:1-Block address public-contact
    • Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
    • Claudia Spies, MD, Prof. 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2016/01/01
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Trial Publications, Results and other Documents

  •   Dalens B, Vanneuville G, Dechelotte P. Penile block via the subpubic space in 100 children. Anesth Analg. 1989 Jul;69(1):41-5.; 2742166
  •   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.; 19889061
  •   Serour F, Mori J, Barr J. Optimal regional anesthesia for circumcision. Anesth Analg. 1994 Jul;79(1):129-31.; 8010422
  •   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.; 8528302
  •   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.; 7867113
  •   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.; 15674514
  •   Yucel S, Baskin LS. Neuroanatomy of the male urethra and perineum. BJU Int. 2003 Oct;92(6):624-30.; 14511049
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2018/04/13


* This entry means the parameter is not applicable or has not been set.