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

NCT04227561 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-19

No results posted yet for this study

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.

Conditions

  • Anesthesia
  • Pediatric Circumcision

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Saint Pierre

    lead OTHER

Principal Investigators

  • Panayota Kapessidou, MD,PhD · University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  • Alexandros Alexis, MD · University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  • Olivier Habchi, MD · University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
2 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-17
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

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View NCT04227561 on ClinicalTrials.gov