PainNCT06545058
Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision: a Large Cohort Study in Children
An observational study of Pain and Necrosis, run by Universitair Ziekenhuis Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 years, men onlyHealthy volunteers can take part
- What is being tested?
- Penile block
- Type of treatment
- Surgery or procedure
- How many people
- 2,086 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 10 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- Men only
- Healthy volunteers accepted
- Child
Study population: All children aged up to 16 years who underwent a circumcision at UZ Brussel, between 1 January 2000 and 31 December 2021
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the detailed description
Circumcision is one of the most practiced surgical procedures in childhood causing significant postoperative pain in the infant. Perioperative and postoperative pain management at this age ideally should be managed by a combination of general anesthesia with regional anesthesia techniques such as caudal block, dorsal penile nerve block or subcutaneous ring block of the penis.
The dorsal nerves of the penis can be anesthetized at the level of the penile root through different approaches. Kirya and Wertgmann described for the first time dorsal penile nerve block. Since then, many studies have been realized and have been showed its benefits and safety in the clinical use.
Ring Blok is also known for its safety and low incidence of complications and has been used primarily for postoperative pain management in circumcision. This block is easy to perform but it has been identified that it has a greater failure compared to the dorsal penile block. In the study of Holder who compares dorsal penile block and ring block, most of the children who has had a ring block also received opioids postoperatively.
Implementation of local or regional anesthesia techniques is inevitably associated with risks and complications. For DPNB, this is estimated around 0.18%. Those complications may include urethral injuries, accidental injection of an incorrect drug or drug dose, accidental intravascular injection of local anesthetics, ischial osteomyelitis, hematoma, and ischemia and necrosis of the glans penis. The dorsal nerves of the penis also lies close to de corpora cavernosa and the Buck's fascia. Given the rich vascularized features of these structure, DNPB may increase the risk of intravascular injection, systemic absorption of local anesthetics or hematoma.
Ischemia or even necrosis of the glans due to the placement of a penile block is a very rare complication that is not seen in the daily practice. Endothelial injury and necrosis is a serious complication that can be caused due to vascular compression because of the mass effect of anesthetic solution or hematoma, perforation of a vein or artery, excessive cauterization, a very tight suture, veno/vasospasm at the glans; secondary to surgery or the dorsal penile nerve block.
Ischemia or necrosis may also be due to the vasoconstrictive effect of local anesthetics, especially if they contain epinephrine.
Cases of ischemia of the glans have been described after the application of the dorsal penile nerve block, this was related to anesthetics that contained epinephrine or another type of vasoconstrictor agent.
Ropivacaine is a local anesthetic drug with a remarkable safe cardiologic and neurologic toxicity profile specially in children. Its administration for dorsal penile nerve block (DPNB) in male penile surgeries, however, has been discouraged because of the fear to cause necrosis of the glans due to its vasoconstrictor properties. In Universitair Ziekenhuis Brussel, we use ropivacaine for this purpose for more than 20 years now with seemingly no significant complications. We want to evaluate the safety of our practice that is associated with the use of ropivacaine in DPNB in the pediatric population, as well as the incidence and type of potential complications. The impact may be important because there are no studies that verify the safety of this local anesthetic for those type of procedures. This cohort study could eventually also serve as quality improvement.
Ropivacaine is a local anesthetic amide-type that has been shown to have vascular biphasic effects, with vasoconstrictive qualities. These properties have been verified in Dahl's study. Where they identified a decrease in epidural blood flow of 37%, compared to the increase in blood flow that they identified after the administration of bupivacaine.
The vasoconstrictive qualities have been related with low ropivacaine concentrations like 0.063% and 0.125%. At higher concentrations like 0.75% has been showed just a little decrease in blood flow comparing with saline. There are currently no other studies in the literature that indicate the risk of using ropivacaine in children for Dorsal Penile Nerve Block (DPNB).
- Being tested
- Penile block
- Keywords
- Circumcision, Pain, Necrosis, Ropivacaine
- Medical subject headings
- Pain, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penile blockProcedure or surgery
Penile block with local anesthetics
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Penile block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2000
- Primary completion31 Dec 2021
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545058
- Sponsor's protocol ID
- Ropopenile
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30035357Sfez 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.
PubMed 2205131Garrido-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.
PubMed 26692685Irwin 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.
PubMed 8805893Sara 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.
PubMed 3977067Jansson 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.
PubMed 18155065Doye 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.
PubMed 25482996Burke 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.
PubMed 10925943Wang 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.
PubMed 31032356Mittino 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.
PubMed 30426879Lander 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.
PubMed 9417009Holder 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.
PubMed 9303286Dahl 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.
PubMed 2343734Najafi 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.
PubMed 27315186
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision: a Large Cohort Study in Children
- ClinicalTrials.gov ID
- NCT06545058
- Acronym / sponsor ID
- Ropopenile
- Keywords
- Circumcision, Pain, Necrosis, Ropivacaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,086 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Circumcision is one of the most practiced surgical procedures in childhood causing significant postoperative pain in the infant. Perioperative and postoperative pain management at this age ideally should be managed by a combination of general anesthesia with regional anesthesia techniques such as caudal block, dorsal penile nerve block or subcutaneous ring block of the penis.
The dorsal nerves of the penis can be anesthetized at the level of the penile root through different approaches. Kirya and Wertgmann described for the first time dorsal penile nerve block. Since then, many studies have been realized and have been showed its benefits and safety in the clinical use.
Ring Blok is also known for its safety and low incidence of complications and has been used primarily for postoperative pain management in circumcision. This block is easy to perform but it has been identified that it has a greater failure compared to the dorsal penile block. In the study of Holder who compares dorsal penile block and ring block, most of the children who has had a ring block also received opioids postoperatively.
Implementation of local or regional anesthesia techniques is inevitably associated with risks and complications. For DPNB, this is estimated around 0.18%. Those complications may include urethral injuries, accidental injection of an incorrect drug or drug dose, accidental intravascular injection of local anesthetics, ischial osteomyelitis, hematoma, and ischemia and necrosis of the glans penis. The dorsal nerves of the penis also lies close to de corpora cavernosa and the Buck's fascia. Given the rich vascularized features of these structure, DNPB may increase the risk of intravascular injection, systemic absorption of local anesthetics or hematoma.
Ischemia or even necrosis of the glans due to the placement of a penile block is a very rare complication that is not seen in the daily practice. Endothelial injury and necrosis is a serious complication that can be caused due to vascular compression because of the mass effect of anesthetic solution or hematoma, perforation of a vein or artery, excessive cauterization, a very tight suture, veno/vasospasm at the glans; secondary to surgery or the dorsal penile nerve block.
Ischemia or necrosis may also be due to the vasoconstrictive effect of local anesthetics, especially if they contain epinephrine.
Cases of ischemia of the glans have been described after the application of the dorsal penile nerve block, this was related to anesthetics that contained epinephrine or another type of vasoconstrictor agent.
Ropivacaine is a local anesthetic drug with a remarkable safe cardiologic and neurologic toxicity profile specially in children. Its administration for dorsal penile nerve block (DPNB) in male penile surgeries, however, has been discouraged because of the fear to cause necrosis of the glans due to its vasoconstrictor properties. In Universitair Ziekenhuis Brussel, we use ropivacaine for this purpose for more than 20 years now with seemingly no significant complications. We want to evaluate the safety of our practice that is associated with the use of ropivacaine in DPNB in the pediatric population, as well as the incidence and type of potential complications. The impact may be important because there are no studies that verify the safety of this local anesthetic for those type of procedures. This cohort study could eventually also serve as quality improvement.
Ropivacaine is a local anesthetic amide-type that has been shown to have vascular biphasic effects, with vasoconstrictive qualities. These properties have been verified in Dahl's study. Where they identified a decrease in epidural blood flow of 37%, compared to the increase in blood flow that they identified after the administration of bupivacaine.
The vasoconstrictive qualities have been related with low ropivacaine concentrations like 0.063% and 0.125%. At higher concentrations like 0.75% has been showed just a little decrease in blood flow comparing with saline. There are currently no other studies in the literature that indicate the risk of using ropivacaine in children for Dorsal Penile Nerve Block (DPNB).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Procedure: Penile blockAll male children aged up to 16 years, who underwent a circumcision at UZ Brussel, between 1 January 2000 and 31 December 2021 |
Who may qualify
- Ages
- Up to 16 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All children aged up to 16 years who underwent a circumcision at UZ Brussel, between 1 January 2000 and 31 December 2021
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Penile blockPenile block with local anesthetics | Procedure or surgery | Study Cohort |
Primary outcome
Incidence of necrosis of the glans penis
Time frame: During time of surgery
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.
Safety profile of Ropivacaine
Time frame: During time of surgery
To evaluate the safety profile of ropivacaine following its use in the Dorsal penile nerve block in a large pediatric population.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Background: PubMed 30035357Teunkens 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.
- Background: PubMed 2205131Sfez 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.
- Background: PubMed 26692685Garrido-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.
- Background: PubMed 8805893Irwin 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.
- Background: PubMed 3977067Sara 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.
- Background: PubMed 18155065Jansson 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.
- Background: PubMed 25482996Doye 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.
- Background: PubMed 10925943Burke 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.
- Background: PubMed 31032356Wang 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.
- Background: PubMed 30426879Mittino 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.
- Background: PubMed 9417009Lander 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.
- Background: PubMed 9303286Holder 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Necrosis, run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of necrosis of the glans penis (time frame: During time of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545058, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.