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

Study Overview
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Brief Summary
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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.

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

Conditions
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Child, Only

Intervention / Treatment
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* Procedure: Ultrasound-guided dorsal penile nerve block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LANDMARK<br>The children who underwent circumcision received general anesthesia plus dorsal penis nerve block performed by the surgeon with a landmark technique. | |
| ULTRASOUND<br>The children who underwent circumcision received sedation (in spontaneous breathing) plus ultrasound-guided dorsal penis nerve block. | Procedure: Ultrasound-guided dorsal penile nerve block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Opioid sparing | The dosage of opioids were measured and compared between the two groups. | 1 hour after beginning of surgery | 
| 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 | 
| Complications | Postoperative complications were analyzed and compared between the two groups. | Immediately after surgery, 4 and 72 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dorsal nerve penis block, sedation, spontaneous breathing, circumcision, pediatric surgery, ultrasound guided