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Compared Reversed US-Guided Dorsal Penile Nerve Block (RUSDPNB) With DPNB in Circumcisions for Pediatric Patients

Study acronym: CIRCUSPRO
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Nov 2024 to Nov 2026
    • Start date changed from estimate of Nov 2024 to Nov 29, 2024
    • Secondary endpoints revised (3)
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Circumcision is a widely performed surgical procedure. For this reason, optimal analgesic management is essential. Loco-regional anesthesia, particularly penile blocks, combined with general anesthesia is the technique of choice for managing analgesia during circumcisions. Ultrasound is increasingly used in locoregional anesthesia techniques. There is already human research on penile blocks and the use of ultrasound. Studies carried out to date describe an optimization of pain relief in children after circumcision compared with the alternative technique without ultrasound, as well as a reduction in local complications due to injection. However, other studies tend to contradict these findings. In order to provide additional knowledge and to verify whether ultrasound could provide with more optimal relief after your circumcision, the investigators are carrying out this study. The investigators are proposing to every patient aged 0 to under 18 who is going to undergo circumcision to take part in this project. A letter is sent to all potential participants no later than 3 days before the operation. Consent can be signed no later than the day of the operation. The cooling-off period is the same regardless of age. Taking part in the study does not affect the operation in any way. The block will take place in the operating room, prior to surgery. In this study, participants are randomized into groups. This method is important for obtaining reliable results. * Group 1 (intervention group): The penile block will be performed using ultrasound. * Group 2 (control group): The penile block will be performed using anatomical landmarks. This is a "single-blind" study, which means that only the anaesthetists, investigators and operating room team will be aware of the allocation to one of the two groups. Data on opiate consumption will be registered as well as the different durations preoperatively, intraoperatively, postoperatively, back in the recovery room and before returning home or any complications as well as pain assessment.
Trial Details
NCT Number NCT06706375
Lead Sponsor Centre Hospitalier Universitaire Vaudois
Conditions
(from sponsor)
Circumcision, Ultrasound, Opioid Consumption, Penile Surgery
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov