Completed

Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing: An Observational Study

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

From 6 Months to 17 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: January 2016
See protocol details

Summary

Principal SponsorAzienda Sanitaria-Universitaria Integrata di Udine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitlePediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing: An Observational Study
NCT04475458
Principal SponsorAzienda Sanitaria-Universitaria Integrata di Udine
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

70 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 6 Months to 17 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
candidates to circumcision

age between 6 months and 17 years

American Society of Anesthesiologists (ASA) physical status < 3

written consent of the parents

4 exclusion criteria prevent from participating
allergies to local anesthetics

younger than 6 months and older than 17 years

ASA physical status =/> 3

no written consent of the parents

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, ItalyOpen Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD in Google Maps
CompletedOne Study Center