CircumcisionCIRCUSPRONCT06706375
Compared Reversed US-Guided Dorsal Penile Nerve Block (RUSDPNB) With DPNB in Circumcisions for Pediatric Patients
A study testing Using ultrasound for penile nerve block and Dorsal Penile Block Anesthesia using landmarks in people with Circumcision and Ultrasound, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years, men only
- Conditions the study is for
- Circumcision, Ultrasound, Opioid Consumption
- What is being tested?
- Using ultrasound for penile nerve block and Dorsal Penile Block Anesthesia using landmarks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Nov 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- male
- undergoing circumcision
- informed consent
Who cannot join
- other surgery than circumcision in the same time
- contraindication to local anesthesia
- allergy to bupivacaine
- chronic opiates treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
sylvain Mauron, Dr Med
About this study
Official title: A Comparison of Reversed-Ultrasound-Guided Dorsal Penile Nerve Block (RUS-DPBP) and DPNB in Circumcisions for Pediatric Patients
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.
Read more
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.
Read the detailed description
30% of men over the age of fifteen worldwide have had a circumcision according to a World Health Organization report. 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. Today, the use of opioids as intra- and postoperative analgesics in pediatric urological surgery remains predominant 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, 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. Long-term addiction is also questioned. Then, opioids don't appear to be the most effective per- and postoperative analgesic drug. Its prescription could and should be reduced. In sum, a safe and effective anesthesia is paramount. Use of loco-regional anesthesia (LRA) during pediatric urological surgeries complements general anesthesia and thus offers more optimal postoperative analgesia.
Dorsal penile nerve block (DPNB) is LRA technique of choice for circumcisions and aims to anesthetize both dorsal penile nerves. The name DPNB is used for blocks performed by determining precise dorsal anatomical landmarks and doing two distinct injections. The main complications observed are lesions of the urethra, vascular complications (bleeding from the prepuce; hematomas) and failure of the block. In recent years, Ultrasound (US), a non-irradiating imaging technique widely used in LRA, has been used more and more to perform the DPNB and the procedure is well known and described. A decrease of the amount of opioid analgesics intraoperatively and postoperatively is observed when US is used. Postoperative pain scores are also better. Two methods of DPNB using US exist. In both approaches, probe is placed along the transverse plan. In the first one at the base of penis, with ventral visualization of structures, US-DPNB. In the second method, Reversed Ultrasound-Guided DPNB (RUS-DPNB), the penis is slightly retracted with probe placed dorsally, under the base of penis and above the scrotum. RUS-DPNB method will be used in this study. However, DPNB and RUS-DPNB are well described and used equally in daily practice.
The aim of this prospective study is to compare DPNB and RUS-DPNB in terms of efficacy, using cumulative analgesic dosage in morphine equivalent per kilogram. In the standard practice, the two methods are performed at discretion of every anaesthesiologist at CHUV. In fact, although RUS-DPNB is part of everyday practice at CHUV, it hasn't become the standard method, as the literature has a lack of data to prove its advantage over the standard method, DPNB.
- Conditions
- Circumcision, Ultrasound, Opioid Consumption, Penile Surgery
- Being tested
- Using ultrasound for penile nerve block, Dorsal Penile Block Anesthesia using landmarks
- Keywords
- circumcision, reversed ultrasound guided dorsal penile nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using ultrasound for penile nerve blockProcedure or surgery
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
Dorsal Penile Block Anesthesia using landmarksProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | Dorsal penile nerve block using ultrasound Receives: Procedure: Using ultrasound for penile nerve block |
| Control | Active comparator | Dorsal penile nerve block using anatomical landmarks Receives: Procedure: Dorsal Penile Block Anesthesia using landmarks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine equivalent
total morphine equivalent will be cumulated and reported
Measured: from enrollment to discharge from hospital, maximum 1 day
Secondary outcomes (3)
times
- Anesthesia time, surgery time, total time in operating room, time in recovery room, time before discharge home
Measured: from enrollment to discharge from hospital, maximum 1 day
Adverse events
- Incidence of adverse events of special interest (complications such as urine retention, bleeding and hematoma, nausea and vomiting).
Measured: 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)
Maximal pain score measured and reported
Measured: from enrollment to discharge from hospital, maximum 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start29 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CircumcisionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706375
- Sponsor's protocol ID
- 2024-00420
- Acronym
- CIRCUSPRO
- Status last verified
- Mar 2026
- First submitted
- 20 Nov 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 22023417Kirya 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.
PubMed 660375Osmani 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.
PubMed 34400101Carolan 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.
PubMed 33901533
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Reversed-Ultrasound-Guided Dorsal Penile Nerve Block (RUS-DPBP) and DPNB in Circumcisions for Pediatric Patients
- ClinicalTrials.gov ID
- NCT06706375
- Acronym / sponsor ID
- CIRCUSPRO / 2024-00420
- Conditions
- Circumcision, Ultrasound, Opioid Consumption, Penile Surgery
- Keywords
- circumcision, reversed ultrasound guided dorsal penile nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 Nov 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.
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.
Detailed description
30% of men over the age of fifteen worldwide have had a circumcision according to a World Health Organization report. 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. Today, the use of opioids as intra- and postoperative analgesics in pediatric urological surgery remains predominant 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, 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. Long-term addiction is also questioned. Then, opioids don't appear to be the most effective per- and postoperative analgesic drug. Its prescription could and should be reduced. In sum, a safe and effective anesthesia is paramount. Use of loco-regional anesthesia (LRA) during pediatric urological surgeries complements general anesthesia and thus offers more optimal postoperative analgesia.
Dorsal penile nerve block (DPNB) is LRA technique of choice for circumcisions and aims to anesthetize both dorsal penile nerves. The name DPNB is used for blocks performed by determining precise dorsal anatomical landmarks and doing two distinct injections. The main complications observed are lesions of the urethra, vascular complications (bleeding from the prepuce; hematomas) and failure of the block. In recent years, Ultrasound (US), a non-irradiating imaging technique widely used in LRA, has been used more and more to perform the DPNB and the procedure is well known and described. A decrease of the amount of opioid analgesics intraoperatively and postoperatively is observed when US is used. Postoperative pain scores are also better. Two methods of DPNB using US exist. In both approaches, probe is placed along the transverse plan. In the first one at the base of penis, with ventral visualization of structures, US-DPNB. In the second method, Reversed Ultrasound-Guided DPNB (RUS-DPNB), the penis is slightly retracted with probe placed dorsally, under the base of penis and above the scrotum. RUS-DPNB method will be used in this study. However, DPNB and RUS-DPNB are well described and used equally in daily practice.
The aim of this prospective study is to compare DPNB and RUS-DPNB in terms of efficacy, using cumulative analgesic dosage in morphine equivalent per kilogram. In the standard practice, the two methods are performed at discretion of every anaesthesiologist at CHUV. In fact, although RUS-DPNB is part of everyday practice at CHUV, it hasn't become the standard method, as the literature has a lack of data to prove its advantage over the standard method, DPNB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Procedure: Using ultrasound for penile nerve blockDorsal penile nerve block using ultrasound |
| Control | Active comparator | Procedure: Dorsal Penile Block Anesthesia using landmarksDorsal penile nerve block using anatomical landmarks |
Who may qualify
- Ages
- Up to 17 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- male
- undergoing circumcision
- informed consent
Key exclusion criteria (4 listed)
- other surgery than circumcision in the same time
- contraindication to local anesthesia
- allergy to bupivacaine
- chronic opiates treatment
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 |
|---|---|---|
| Using ultrasound for penile nerve block30% 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 | Procedure or surgery | interventional |
| Dorsal Penile Block Anesthesia using landmarksDorsal 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. | Procedure or surgery | Control |
Primary outcome
Total morphine equivalent
Time frame: from enrollment to discharge from hospital, maximum 1 day
total morphine equivalent will be cumulated and reported
3 secondary outcomes
times
Time frame: from enrollment to discharge from hospital, maximum 1 day
Adverse events
Time frame: 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)
Time frame: from enrollment to discharge from hospital, maximum 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 22023417O'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.
- Background: PubMed 660375Kirya 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.
- Background: PubMed 34400101Osmani 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.
- Background: PubMed 33901533Carolan 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Circumcision
Not yet recruitingObservational study
Preoperative Fasting and Perioperative Outcomes in Children Undergoing Elective Circumcision
Preoperative Fasting, Perioperative Anxiety
Active, not recruiting
A Study Comparing The Effect Of Local Application Of Polyfax Versus Coconut Oil On Outcome Of Plastibell Circumcision In A Tertiary Care Hospital
Circumcision, Male
Not yet recruiting
Effects of Therapeutic Touch and Music on Children's Anxiety, Pain, and Nausea Before and After Circumcision
Circumcision
Not yet recruitingPhase 2
Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
Posterior Urethral Valves
Recruiting
VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures
Urologic Diseases, Prostate Biopsy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using ultrasound for penile nerve block and Dorsal Penile Block Anesthesia using landmarks in people with Circumcision and Ultrasound, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 3 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvain Mauron, Dr Med (+41797046359, sylvain.mauron@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine equivalent (time frame: from enrollment to discharge from hospital, maximum 1 day). 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 NCT06706375, which also lists 4 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 27 Mar 2026.