NCT04475458

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

5.8 years

First QC Date

July 10, 2020

Last Update Submit

November 5, 2022

Conditions

Child, Only

Keywords

dorsal nerve penis blocksedationspontaneous breathingcircumcisionpediatric surgeryultrasound guided

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of patients needed ventilation

    1 hour after beginning of surgery

  • Opioid sparing

    1 hour after beginning of surgery

  • Postoperative pain

    Immediately after surgery, 4 and 72 hours after surgery

  • Complications

    Immediately after surgery, 4 and 72 hours after surgery

Study Arms (2)

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

Interventions

Ultrasound-guided dorsal penile nerve blockPROCEDURE

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.

ULTRASOUND

Eligibility Criteria

Age6 Months - 17 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Location

Related Publications (5)

  • 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.

    PMID: 18843636BACKGROUND

  • 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.

    PMID: 29939703BACKGROUND

  • 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: 17444318BACKGROUND

  • 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.

    PMID: 22023417BACKGROUND

  • 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.

    PMID: 38116040DERIVED

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 17, 2020

Study Start

January 1, 2016

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations

IT(1)