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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04475458
Enrollment
70
Registered
2020-07-17
Start date
2016-01-01
Completion date
2021-10-01
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child, Only

Keywords

dorsal nerve penis block, sedation, spontaneous breathing, circumcision, pediatric surgery, ultrasound guided

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.

Interventions

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.

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
6 Months to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to discharge1 hour after end of surgeryThe time to discharge from the operating room to the post-anesthesia care unit is measured and compared between the two groups.

Secondary

MeasureTime frameDescription
Number of patients needed ventilation1 hour after beginning of surgeryPatients who received general anesthesia where all ventilated mechanically. In the ultrasound group, patients maintained spontaneous breathing and were noted the ones who needed ventilation.
Opioid sparing1 hour after beginning of surgeryThe dosage of opioids were measured and compared between the two groups.
Postoperative painImmediately after surgery, 4 and 72 hours after surgeryPain 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.
ComplicationsImmediately after surgery, 4 and 72 hours after surgeryPostoperative complications were analyzed and compared between the two groups.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026