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

Azienda Sanitaria-Universitaria Integrata di Udine70 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Child, Only

Interventions

Ultrasound-guided dorsal penile nerve blockPROCEDURE

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.

Eligibility

Sex: MALEMin age: 6 MonthsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, Italy

Outcomes

Primary Outcomes

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.

Time frame: 1 hour after end of surgery

Secondary Outcomes

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.

Time frame: 1 hour after beginning of surgery

Opioid sparing

The dosage of opioids were measured and compared between the two groups.

Time frame: 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.

Time frame: Immediately after surgery, 4 and 72 hours after surgery

Complications

Postoperative complications were analyzed and compared between the two groups.

Time frame: Immediately after surgery, 4 and 72 hours after surgery

Data from ClinicalTrials.gov

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