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

Child, Only Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475458
• Other study ID #: Ultrasound guided DPNB
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: October 1, 2021

Study information

• Verified date: November 2022
• Source: Azienda Sanitaria-Universitaria Integrata di Udine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
Italy	Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria-Universitaria Integrata di Udine

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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;(4):CD003005. doi: 10.1002/14651858.CD003005.pub2. Review. — View Citation

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. — View Citation

Sandeman DJ, Dilley AV. Ultrasound guided dorsal penile nerve block in children. Anaesth Intensive Care. 2007 Apr;35(2):266-9. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Opioid sparing	The dosage of opioids were measured and compared between the two groups.	1 hour after beginning of surgery
Secondary	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
Secondary	Complications	Postoperative complications were analyzed and compared between the two groups.	Immediately after surgery, 4 and 72 hours after surgery