CompletedNot Applicable

Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision: a Large Cohort Study in Children

2,086 participantsStarted 2000-01-01

Plain-language summary

Dorsal penile nerve block (DPNB) according to Dalens' technique by using local anesthetics (LAs) is a fundamental part of a multimodal analgesic approach following circumcision. Ropivacaine has a favorable cardiovascular and neurological toxicity profile. However, its application in DPNB is limited because of the theoretical concerns about its vasoconstrictive properties and the potential risks of ischemia of the glans. The aim is to evaluate the incidence of necrosis of the glans penis and the safety profile of ropivacaine following its use in the DPNB in a large pediatric population.

Who can participate

Age range16 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All male children aged up to 16 years * All circumcision made at UZ Brussel * All revision of circumcision made at UZ Brussel * All procedures between 1 January 2000 and 31 December 2021 * All type ASA * Penile Block performed by anesthesiologist * All Penile Block performed with local anesthetics at diverse concentrations Exclusion Criteria: * Canceled procedure * Missing anesthetic records * Children who received caudal block by anesthesiologist in charge * Children who received local infiltration of local anesthetics by the surgeon

What they're measuring

Incidence of necrosis of the glans penis

Timeframe: During time of surgery

Safety profile of Ropivacaine

Timeframe: During time of surgery

Trial details

NCT IDNCT06545058

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-31

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