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

NCT04227561 | Unknown

• 1 other identifier: B076201941947
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pediatric Circumcision

Keywords

penile nerve block; pudendal nerve block

Outcome Measures

Primary Outcomes (1)

• Time to first administration of analgesics (other than nervous blockage after induction of anesthesia)

  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

  up to 24 hours

Secondary Outcomes (2)

• Postoperative pain assessed with the EVENDOL score

  up to 24 hours

• Postoperative pain assessed by a pain monitor device (skin conductance algesimeter)

  up to 24 hours

Study Arms (2)

Pudendal nerve block

ACTIVE COMPARATOR

Neurostimulation-guided pudendal nerve block

Procedure: Pudendal nerve block

Penile nerve block

ACTIVE COMPARATOR

Ultrasound-guided penile nerve block

Procedure: Penile nerve block

Interventions

Pudendal nerve block PROCEDURE

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.

Pudendal nerve block

Penile nerve block PROCEDURE

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.

Penile nerve block

Eligibility Criteria

• Age: 1 Year - 2 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)

Brussels, Brussels Capital, 1000, Belgium

RECRUITING

Related Publications (6)

• 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.

  PMID: 20849498 BACKGROUND

• 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.

  PMID: 17444318 BACKGROUND

• 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.

  PMID: 18829782 BACKGROUND

• Bateman DV. An alternative block for the relief of pain of circumcision. Anaesthesia; 1975, 30:101-2

  BACKGROUND

• Müller B. Narkologie. Band II, 88. Berlin: Trankel; 1908. p.15.

  BACKGROUND

• B. Dalens. Traité d'anesthésie générale. Arnette,11/01. ISBN: 2-7184-1022-1.

  BACKGROUND

Study Officials

• Panayota Kapessidou, MD,PhD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  STUDY DIRECTOR

• Alexandros Alexis, MD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  PRINCIPAL INVESTIGATOR

• Olivier Habchi, MD

  University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panayota Kapessidou, MD,PhD

CONTACT

+32.2.535; pkapessi@ulb.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 13, 2020
• Study Start: January 17, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 19, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)