Clinical trial NCT04227561: Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Pudendal Nerve Block to Penile Nerve Block
Official title: Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Neurostimulation-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Pediatric Circumcision
Keywords: penile nerve block
pudendal nerve block
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 40
Sex: MALE
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Medical or ritual circumcisions are frequent interventions in children. To provide the best comfort to the patients, the anesthetists use regional anesthesia. Complementary to general anesthesia, this method allows to lower the need of opioids during and after the surgery, as well as a faster recovery.

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.


Eligibility criteria: Inclusion Criteria:

* One to two years old boys
* Ritual or medical, elective circumcision.

Exclusion Criteria:

* Refusal from parents
* Allergy to local anesthetics
* Documented coagulation disorders
* Epilepsy

Primary outcomes:
measure: Time to first administration of analgesics (other than nervous blockage after induction of anesthesia)
timeFrame: up to 24 hours
Secondary outcomes:
measure: Postoperative pain assessed with the EVENDOL score
timeFrame: up to 24 hours
measure: Postoperative pain assessed by a pain monitor device (skin conductance algesimeter)
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
state: Brussels Capital Region,
Study officials:
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Panayota Kapessidou, MD,PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Alexandros Alexis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Olivier Habchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Bateman DV. An alternative block for the relief of pain of circumcision. Anaesthesia; 1975, 30:101-2
citation: Müller B. Narkologie. Band II, 88. Berlin: Trankel; 1908. p.15.
citation: B. Dalens. Traité d'anesthésie générale. Arnette,11/01. ISBN: 2-7184-1022-1.