Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Pudendal Nerve Block to Penile Nerve Block

Not Applicable

• Conditions: Pediatric Circumcision; Anesthesia
• Interventions: Procedure: Penile nerve block; Procedure: Pudendal nerve block

• Registration Number: NCT04227561
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-01-17
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Penile nerve block	Penile nerve block	Ultrasound-guided penile nerve block
Pudendal nerve block	Pudendal nerve block	Neurostimulation-guided pudendal nerve block

Primary Outcome Measures

Name	Time	Method
Time to first administration of analgesics (other than nervous blockage after induction of anesthesia)	up to 24 hours	Pain evaluation during surgery will be based on hemodynamic fluctuations (elevation of 15% or more of the heart rate or blood pressure) and variations of skin conductance (Med-Storm's pain monitor). In the postoperative period, the pain will be evaluated with the EVENDOL score and the variations of skin conductance

Secondary Outcome Measures

Name	Time	Method
Postoperative pain assessed with the EVENDOL score	up to 24 hours	Pain will be assessed with the EVENDOL score (score 0 to 15) at T0 (upon arrival in the recovery room), T1 (30 minutes post-surgery), T2 (1 hour post-surgery), T3 (3 hours post-surgery). EVENDOL scale is a behavioral pain scale for children aged 0 to 7 years.
Postoperative pain assessed by a pain monitor device (skin conductance algesimeter)	up to 24 hours	Continuous variations of skin conductance will be measured and analyzed during the operation

Trial Locations

Locations (1)

University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB); 🇧🇪 Brussels, Brussels Capital Region,, Belgium