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

NCT06706375 | Recruiting

• 1 other identifier: 2024-00420
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circumcision; Ultrasound; Penile Surgery; Opioid Consumption

Keywords

circumcision; reversed ultrasound guided dorsal penile nerve block

Outcome Measures

Primary Outcomes (1)

• Total morphine equivalent

  total morphine equivalent will be cumulated and reported

  from enrollment to discharge from hospital, maximum 1 day

Secondary Outcomes (3)

• times

  from enrollment to discharge from hospital, maximum 1 day

• Adverse events

  from enrollment to discharge from hospital, maximum 1 day

• Pain score using Face Leg Activity Cry Consolability (FLACC) or FACES or Visual Analog Scale (VAS), from 0 (no pain) to 10 (worse pain)

  from enrollment to discharge from hospital, maximum 1 day

Study Arms (2)

interventional

EXPERIMENTAL

Dorsal penile nerve block using ultrasound

Procedure: Using ultrasound for penile nerve block

Control

ACTIVE COMPARATOR

Dorsal penile nerve block using anatomical landmarks

Procedure: Dorsal Penile Block Anesthesia using landmarks

Interventions

Using ultrasound for penile nerve block PROCEDURE

30% of men over the age of fifteen worldwide have had a circumcision according to a World Health Organization report. (1) This operation is common and should not be trivialized. A certain number of surgical complications should be considered, including pain, infections, excessive bleeding or hematomas. (1,2) Today, the use of opioids as intra- and postoperative analgesics in pediatric urological surgery remains predominant (3) but is the subject of increasing controversies. Indeed, the recent opioid crisis challenges us about their use and highlights their multiple side effects. First of all, their use involves significant risks, (4) including opioid-induced hyperalgesia and potential long-term effects. An increase in pain sensitivity within the 24 postoperative hours being proportional to intraoperative administration of high doses of opioids can be observed. (5) Long-term addiction is also questioned. Then, opioids don't appear to be the most effective per- and postoperative analgesi

interventional

Dorsal Penile Block Anesthesia using landmarks PROCEDURE

Dorsal penile nerve block (DPNB) is LRA technique of choice for circumcisions and aims to anesthetize both dorsal penile nerves. (10-12) The name DPNB is used for blocks performed by determining precise dorsal anatomical landmarks and doing two distinct injections.

Control

Eligibility Criteria

• Age: Up to 17 Years
• Gender Eligibility Details: males only as it is circumcision
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• male
• undergoing circumcision
• informed consent

You may not qualify if:

• other surgery than circumcision in the same time
• contraindication to local anesthesia
• allergy to bupivacaine
• chronic opiates treatment

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Related Publications (4)

• O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.

  PMID: 22023417 BACKGROUND

• Kirya C, Werthmann MW Jr. Neonatal circumcision and penile dorsal nerve block--a painless procedure. J Pediatr. 1978 Jun;92(6):998-1000. doi: 10.1016/s0022-3476(78)80386-2.

  PMID: 660375 BACKGROUND

• Osmani F, Ferrer F, Barnett NR. Regional anesthesia for ambulatory pediatric penoscrotal procedures. J Pediatr Urol. 2021 Dec;17(6):836-844. doi: 10.1016/j.jpurol.2021.07.017. Epub 2021 Jul 24.

  PMID: 34400101 BACKGROUND

• Carolan AMC, Parker KM, Grimsby GM. Opioid Use after Pediatric Urologic Surgery: Is It Really Needed? Urology. 2021 Dec;158:184-188. doi: 10.1016/j.urology.2021.04.012. Epub 2021 Apr 24.

  PMID: 33901533 BACKGROUND

Central Study Contacts

Sylvain Mauron, Dr Med

CONTACT

+41797046359; sylvain.mauron@chuv.ch

Boand Mélanie, Research nurse

CONTACT

+41 79 556 82 92; melanie.boand@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Patrick Schoettker, head of anesthesiology service, CHUV, Lausanne, Switzerland

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 26, 2024
• Study Start: November 29, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: Any researcher or journal contacting the PI with clear and well-founded request

Locations

CH (1)