Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing

NCT ID: NCT04475458

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-10-01

Brief Summary

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One of the most frequent surgical procedures in the pediatric population is circumcision, following which postoperative pain could be stressful. Usually, the most common approach is combining regional anesthesia techniques such as landmark dorsal penile nerve block (DPNB) with general anesthesia (GA). The hypothesis of this study investigates ultrasound-guided DPNB plus sedation in spontaneous breathing.

Detailed Description

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Conditions

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Child, Only

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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LANDMARK

The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique.

No interventions assigned to this group

ULTRASOUND

The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block.

Ultrasound-guided dorsal penile nerve block

Intervention Type PROCEDURE

This block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released.

Interventions

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Ultrasound-guided dorsal penile nerve block

This block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* candidates to circumcision
* age between 6 months and 17 years
* American Society of Anesthesiologists (ASA) physical status \< 3
* written consent of the parents

Exclusion Criteria

* allergies to local anesthetics
* younger than 6 months and older than 17 years
* ASA physical status =/\> 3
* no written consent of the parents
Minimum Eligible Age

6 Months

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Azienda Sanitaria-Universitaria Integrata di Udine

OTHER

Sponsor Role lead

Responsible Party

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Luigi Vetrugno

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, , Italy

Site Status

Countries

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Italy

References

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Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.

Reference Type BACKGROUND
PMID: 18843636 (View on PubMed)

Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.

Reference Type BACKGROUND
PMID: 29939703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17444318 (View on PubMed)

O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.

Reference Type BACKGROUND
PMID: 22023417 (View on PubMed)

Dottore B, Meroi F, Tomasino S, Orso D, Comuzzi M, Vernaccini N, Vetrugno L, Intini S, Bove T. Pediatric ultrasound-guided dorsal penile nerve block and sedation in spontaneous breathing: a prospective observational study. Front Med (Lausanne). 2023 Dec 4;10:1268594. doi: 10.3389/fmed.2023.1268594. eCollection 2023.

Reference Type DERIVED
PMID: 38116040 (View on PubMed)

Other Identifiers

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Ultrasound guided DPNB

Identifier Type: -

Identifier Source: org_study_id

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