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

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

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.

Study Overview

• Status: Completed
• Conditions: Child, Only
• Intervention / Treatment: Procedure: Ultrasound-guided dorsal penile nerve block

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Italy
  • Udine, Italy, 33100
    • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients' anthropometric data were collected. Data related to the anesthetic technique, pharmacological therapy, vital parameters were registered as well as the time to discharge from the operatory room to the post-anesthesia care unit.

Opioid consumption and nonsteroidal anti-inflammatory drugs during and after surgery were noted. Pain and complications immediately after surgery, at 4 and 72 hours after surgery were registered.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
LANDMARK; The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique.
ULTRASOUND; The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to discharge	The time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.	1 hour after end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients needed ventilation	Patients who received general anesthesia where all ventilated mechanically. In the ultrasound group, patients maintained spontaneous breathing and were noted the ones who needed ventilation.	1 hour after beginning of surgery
Opioid sparing	The dosage of opioids were measured and compared between the two groups.	1 hour after beginning of surgery
Postoperative pain	Pain levels were compared between the two groups with the Faces, Legs, Activity, Cry and Consolability (FLACC) scale for children < 3 years (a score between 0 and 3 corresponds to a slight pain, in the range 4-7 to moderate pain and score> 7 to a severe pain), faces pain scale for children between 3 e 8 years (the scale shows a series of faces ranging from a happy face or no hurt at score 0, to a crying face at score 10, which represents "hurts like the worst pain imaginable", the patient chooses the face that best describes their level of pain) and the numerical rate scale (NRS) for children > 8 years-old (patients are asked to circle the number between 0 and 10 that fits best to their pain intensity, zero represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'). Analgesics and nonsteroidal anti-inflammatory drugs were registered in the two groups.	Immediately after surgery, 4 and 72 hours after surgery
Complications	Postoperative complications were analyzed and compared between the two groups.	Immediately after surgery, 4 and 72 hours after surgery

Collaborators and Investigators

• Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: sedation; pediatric surgery; circumcision; ultrasound guided; spontaneous breathing; dorsal nerve penis block
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: Ultrasound guided DPNB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No