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

NCT06545058 | Completed

• 1 other identifier: Ropopenile
• Study Type: observational
• Target: 2,086
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Necrosis; Pain

Keywords

Circumcision; Pain; Necrosis; Ropivacaine

Outcome Measures

Primary Outcomes (2)

• Incidence of necrosis of the glans penis

  To evaluate the incidence of necrosis of the glans penis following the use of ropivacaine in the Dorsal penile nerve block in a large pediatric population.

  During time of surgery

• Safety profile of Ropivacaine

  To evaluate the safety profile of ropivacaine following its use in the Dorsal penile nerve block in a large pediatric population.

  During time of surgery

Study Arms (1)

Study Cohort

All male children aged up to 16 years, who underwent a circumcision at UZ Brussel, between 1 January 2000 and 31 December 2021

Procedure: Penile block

Interventions

Penile block PROCEDURE

Penile block with local anesthetics

Study Cohort

Eligibility Criteria

• Age: Up to 16 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children aged up to 16 years who underwent a circumcision at UZ Brussel, between 1 January 2000 and 31 December 2021

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Related Publications (14)

• Teunkens A, Van de Velde M, Vermeulen K, Van Loon P, Bogaert G, Fieuws S, Rex S. Dorsal penile nerve block for circumcision in pediatric patients: A prospective, observer-blinded, randomized controlled clinical trial for the comparison of ultrasound-guided vs landmark technique. Paediatr Anaesth. 2018 Aug;28(8):703-709. doi: 10.1111/pan.13429. Epub 2018 Jul 23.

  PMID: 30035357 BACKGROUND

• Sfez M, Le Mapihan Y, Mazoit X, Dreux-Boucard H. Local anesthetic serum concentrations after penile nerve block in children. Anesth Analg. 1990 Oct;71(4):423-6. doi: 10.1213/00000539-199010000-00019. No abstract available.

  PMID: 2205131 BACKGROUND

• Garrido-Abad P, Suarez-Fonseca C. Glans ischemia after circumcision and dorsal penile nerve block: Case report and review of the literature. Urol Ann. 2015 Oct-Dec;7(4):541-3. doi: 10.4103/0974-7796.164862.

  PMID: 26692685 BACKGROUND

• Irwin MG, Cheng W. Comparison of subcutaneous ring block of the penis with caudal epidural block for post-circumcision analgesia in children. Anaesth Intensive Care. 1996 Jun;24(3):365-7. doi: 10.1177/0310057X9602400311.

  PMID: 8805893 BACKGROUND

• Sara CA, Lowry CJ. A complication of circumcision and dorsal nerve block of the penis. Anaesth Intensive Care. 1985 Feb;13(1):79-82. doi: 10.1177/0310057X8501300111. No abstract available.

  PMID: 3977067 BACKGROUND

• Jansson JR. Vasoactivity of ropivacaine. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):90-1; author reply 91-2. doi: 10.1016/j.rapm.2007.08.011. No abstract available.

  PMID: 18155065 BACKGROUND

• Doye E, Desgranges FP, Stamm D, de Queiroz M, Valla FV, Javouhey E. [Severe local anesthetic intoxication in an infant undergoing circumcision]. Arch Pediatr. 2015 Mar;22(3):303-5. doi: 10.1016/j.arcped.2014.10.023. Epub 2014 Nov 15. French.

  PMID: 25482996 BACKGROUND

• Burke D, Joypaul V, Thomson MF. Circumcision supplemented by dorsal penile nerve block with 0.75% ropivacaine: a complication. Reg Anesth Pain Med. 2000 Jul-Aug;25(4):424-7. doi: 10.1053/rapm.2000.7594.

  PMID: 10925943 BACKGROUND

• Wang X, Dong C, Beekoo D, Qian X, Li J, Shang-Guan WN, Jiang X. Dorsal Penile Nerve Block via Perineal Approach, an Alternative to a Caudal Block for Pediatric Circumcision: A Randomized Controlled Trial. Biomed Res Int. 2019 Mar 27;2019:6875756. doi: 10.1155/2019/6875756. eCollection 2019.

  PMID: 31032356 BACKGROUND

• Mittino I, Sangalli M, Fabbri F, Sozzi F, Ghezzi M, Zanni G, Cestari A. Ischemia of the glans 24 hours after circumcision: A case report and therapeutic solution. Urologia. 2018 Nov;85(4):174-176. doi: 10.1177/0391560318761288. Epub 2018 Mar 26.

  PMID: 30426879 BACKGROUND

• Lander J, Brady-Fryer B, Metcalfe JB, Nazarali S, Muttitt S. Comparison of ring block, dorsal penile nerve block, and topical anesthesia for neonatal circumcision: a randomized controlled trial. JAMA. 1997 Dec 24-31;278(24):2157-62.

  PMID: 9417009 BACKGROUND

• Holder KJ, Peutrell JM, Weir PM. Regional anaesthesia for circumcision. Subcutaneous ring block of the penis and subpubic penile block compared. Eur J Anaesthesiol. 1997 Sep;14(5):495-8. doi: 10.1046/j.1365-2346.1997.00180.x.

  PMID: 9303286 BACKGROUND

• Dahl JB, Simonsen L, Mogensen T, Henriksen JH, Kehlet H. The effect of 0.5% ropivacaine on epidural blood flow. Acta Anaesthesiol Scand. 1990 May;34(4):308-10. doi: 10.1111/j.1399-6576.1990.tb03092.x.

  PMID: 2343734 BACKGROUND

• Najafi N, Veyckemans F, Du Maine C, van de Velde A, de Backer A, Vanderlinden K, Poelaert J. Systemic Toxicity Following the Use of 1% Ropivacaine for Pediatric Penile Nerve Block. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):549-50. doi: 10.1097/AAP.0000000000000415. No abstract available.

  PMID: 27315186 BACKGROUND

MeSH Terms

Conditions

Pain; Necrosis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2000
• Primary Completion: December 31, 2021
• Study Completion: December 10, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12