NCT04475458|Completed
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Sponsor study identifier
observational
70
1 country
1
Study Start
January 1, 2016
Actual (reported)Primary Completion
October 1, 2021
Actual (reported)Study Completion
October 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2016
Actual (reported)July 10, 2020
Actual (reported)July 17, 2020
Actual (reported)October 1, 2021
Actual (reported)October 1, 2021
Actual (reported)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
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
The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique.
The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Udine, 33100, Italy
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.
70 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2020
First Posted
July 17, 2020
Study Start
January 1, 2016
Actual (reported)Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
October 1, 2021
Actual (reported)Study Completion
October 1, 2021
Actual (reported)Last Updated
November 8, 2022
Record last verified: 2022-11
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Source: ClinicalTrials.gov.
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