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

C

Centre Hospitalier Universitaire Saint Pierre

Status

Unknown

Conditions

Pediatric Circumcision
Anesthesia

Treatments

Procedure: Penile nerve block
Procedure: Pudendal nerve block

Study type

Interventional

Funder types

Other

Identifiers

NCT04227561
B076201941947

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Male

Ages

1 to 2 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Pudendal nerve block
Active Comparator group
Description:
Neurostimulation-guided pudendal nerve block
Treatment:
Procedure: Pudendal nerve block
Penile nerve block
Active Comparator group
Description:
Ultrasound-guided penile nerve block
Treatment:
Procedure: Penile nerve block

Trial contacts and locations

1

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Central trial contact

Panayota Kapessidou, MD,PhD

Data sourced from clinicaltrials.gov

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