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

Anesthesia Clinical Trial

Official title:

Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Neurostimulation-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04227561
• Other study ID #: B076201941947
• Status: Recruiting
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: Centre Hospitalier Universitaire Saint Pierre
• Contact: Panayota Kapessidou, MD,PhD
• Phone: +32.2.535
• Email: pkapessi[@]ulb.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 1 Year to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pediatric Circumcision

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)	Brussels	Brussels Capital Region,

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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

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

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. — View 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. — View Citation

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

Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative pain assessed with the EVENDOL score	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.	up to 24 hours
Secondary	Postoperative pain assessed by a pain monitor device (skin conductance algesimeter)	Continuous variations of skin conductance will be measured and analyzed during the operation	up to 24 hours