Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Pudendal Nerve Block to Penile Nerve Block
NCT ID: NCT04227561
Last Updated: 2020-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-01-17
2020-12-31
Brief Summary
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The foreskin is innervated by the dorsal nerve of the penis which is the branch of the pudendal nerve. This nerve arises from the sacral plexus and more precisely the branches S2-3-4. There are two methods to block pudendal nerve. First, the pudendal nerve block is an old anesthetic technique developed in 1908, first for obstetrical analgesia and urological analgesia. It consists in injecting in the ischiorectal fossa, right at the end of Alcock's canal, a solution of local anesthetic. Second, the penile nerve block, described in the middle of the seventies, consists in injecting a solution of local anesthetic that blocks only the terminal part of the pudendal nerve.
Those two nerve blocks have been subject to many publications, especially concerning the method to apply to optimize their efficiency. The literature review led to this conclusion: The penile nerve block should be ultrasound guided and the pudendal nerve block should be done with a neurostimulator.
The aim of this study is to compare the analgesic efficiency of the ultra-sound guided penile nerve block to the pudendal nerve block with neurostimulation, for the pediatric circumcision.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pudendal nerve block
Neurostimulation-guided pudendal nerve block
Pudendal nerve block
Pudendal nerve block will be performed under general anesthesia and guided by neurostimulation.
The local anesthetic solution (chirocaine 2.5mg/ml) will be injected in the ischiorectal fossa with a needle (a BBraun Stimuplex Ultra 360 22G 50mm needle) connected to a neurostimulator (Stimuplex HNS 12 neurostimulator). The neurostimulator will be used to determine the localization of pudendal nerve and to identify the precise site of injection. The contraction of the anal sphincter or bulbocavernosus muscle occurs when the pudendal nerve is reached.
These procedure will be performed bilaterally.
Penile nerve block
Ultrasound-guided penile nerve block
Penile nerve block
The local anesthetic solution (chirocaine 2.5mg/ml) will be injected under the fascia of Scarpa with a real-time ultrasound guidance.
These procedure will be performed bilaterally.
Interventions
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Pudendal nerve block
Pudendal nerve block will be performed under general anesthesia and guided by neurostimulation.
The local anesthetic solution (chirocaine 2.5mg/ml) will be injected in the ischiorectal fossa with a needle (a BBraun Stimuplex Ultra 360 22G 50mm needle) connected to a neurostimulator (Stimuplex HNS 12 neurostimulator). The neurostimulator will be used to determine the localization of pudendal nerve and to identify the precise site of injection. The contraction of the anal sphincter or bulbocavernosus muscle occurs when the pudendal nerve is reached.
These procedure will be performed bilaterally.
Penile nerve block
The local anesthetic solution (chirocaine 2.5mg/ml) will be injected under the fascia of Scarpa with a real-time ultrasound guidance.
These procedure will be performed bilaterally.
Eligibility Criteria
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Inclusion Criteria
* Ritual or medical, elective circumcision.
Exclusion Criteria
* Allergy to local anesthetics
* Documented coagulation disorders
* Epilepsy
1 Year
2 Years
MALE
Yes
Sponsors
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Centre Hospitalier Universitaire Saint Pierre
OTHER
Responsible Party
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Principal Investigators
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Panayota Kapessidou, MD,PhD
Role: STUDY_DIRECTOR
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Alexandros Alexis, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Olivier Habchi, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
Locations
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University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
Brussels, Brussels Capital, Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth. 2010 Oct;20(10):931-6. doi: 10.1111/j.1460-9592.2010.03405.x.
Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. doi: 10.1177/0310057X0703500217.
Gjerstad AC, Wagner K, Henrichsen T, Storm H. Skin conductance versus the modified COMFORT sedation score as a measure of discomfort in artificially ventilated children. Pediatrics. 2008 Oct;122(4):e848-53. doi: 10.1542/peds.2007-2545.
Bateman DV. An alternative block for the relief of pain of circumcision. Anaesthesia; 1975, 30:101-2
Müller B. Narkologie. Band II, 88. Berlin: Trankel; 1908. p.15.
B. Dalens. Traité d'anesthésie générale. Arnette,11/01. ISBN: 2-7184-1022-1.
Other Identifiers
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B076201941947
Identifier Type: -
Identifier Source: org_study_id
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