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Completed

NCT Number: NCT04475458

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

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.

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Key information

Conditions

Child, Only

Age range

6 month–17 year

Sex eligibility

Male

Study type

Observational

Primary location

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided dorsal penile nerve block

Procedure

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.

Primary outcomes

  1. Time to discharge

    Time frame: 1 hour after end of surgery

    The time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.

Secondary outcomes

  1. Number of patients needed ventilation

    Time frame: 1 hour after beginning of surgery

    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.

  2. Opioid sparing

    Time frame: 1 hour after beginning of surgery

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

  3. Postoperative pain

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

    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.

  4. Complications

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

    Postoperative complications were analyzed and compared between the two groups.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2020
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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