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

Completed

• Conditions: Child, Only
• Interventions: Procedure: Ultrasound-guided dorsal penile nerve block

• Registration Number: NCT04475458
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-17
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-05
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ULTRASOUND	Ultrasound-guided dorsal penile nerve block	The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Opioid sparing	1 hour after beginning of surgery	The dosage of opioids were measured and compared between the two groups.
Postoperative pain	Immediately after surgery, 4 and 72 hours after surgery	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.
Complications	Immediately after surgery, 4 and 72 hours after surgery	Postoperative complications were analyzed and compared between the two groups.
Number of patients needed ventilation	1 hour after beginning of surgery	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.

Trial Locations

Locations (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD; 🇮🇹 Udine, Italy