Clinical trial NCT04475458: Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing
Official title: Pediatric Ultrasound-guided Dorsal Penile Nerve Block Plus Sedation in Spontaneous Breathing: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child, Only
Keywords: dorsal nerve penis block
sedation
spontaneous breathing
circumcision
pediatric surgery
ultrasound guided
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 70
Sex: MALE
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to discharge
timeFrame: 1 hour after end of surgery
Secondary outcomes:
measure: Number of patients needed ventilation
timeFrame: 1 hour after beginning of surgery
measure: Opioid sparing
timeFrame: 1 hour after beginning of surgery
measure: Postoperative pain
timeFrame: Immediately after surgery, 4 and 72 hours after surgery
measure: Complications
timeFrame: Immediately after surgery, 4 and 72 hours after surgery
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Study officials:
References:
citation: 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.
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.
citation: 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.
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.