Postoperative CarePinEAPPLENCT07191938
Posthectomy in Pediatric Elective Surgery : a Comparison of Perioperative Analgesia Using Echo-guided Penile Block and Pudendal Block With neurostimuLation Technique
A study testing Ultrasound guided penile block and Neurostimulation guided pudendal block in people with Postoperative Care and Analgesia Assessment, run by University Hospital, Caen at 1 site in France.
Trial summary
Context : Posthectomy is a surgical procedure that concerns around 30% of the male population, mainly in pediatrics. As this procedure is mainly performed on an outpatient basis, the implementation of an enhanced rehabilitation protocol after surgery in pediatrics helps to reduce the incidence of postoperative pain… Read more about this study
- Who is it for?
- Ages 12 weeks to 18 years, men only
- Conditions the study is for
- Postoperative Care, Analgesia Assessment, Posthectomy
- What is being tested?
- Ultrasound guided penile block and Neurostimulation guided pudendal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Dec 2028
- 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 12 weeks to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children aged over 3 months or 60 weeks post-conceptional age scheduled for outpatient posthectomy surgery
Who cannot join
- Recent airway infection.
- Contraindication to locoregional anesthesia: infection and/or loss of substance at the puncture site, congenital or acquired coagulopathy, product allergy.
- Contraindication to outpatient treatment: age < 12 weeks for healthy children or 60 weeks corrected age for premature babies, unbalanced pre-existing pathology (respiratory), ability to understand and comply with instructions (pre-operative fasting, taking painkillers at home and resumption of feeding), inability to ensure the presence of 2 adults including 1 parent on the return journey by car for children < 10 years old, easy access to care close to home.
- Emergency surgery.
- Coupled surgery (posthectomy + other surgery).
- Parents' refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de Caen
Caen, Normandy, 14000
Marine A Rolland, MD, +33699014734, rolland-m@chu-caen.fr
Marine A Rolland, MD
About this study
Official title: Comparison of Echo-guided Penile Block and Pudendal Block Under Neurostimulation for Perioperative Analgesia of Posthectomy in Pediatric Surgery: a Prospective, Randomized Study at Caen University Hospital
Context : Posthectomy is a surgical procedure that concerns around 30% of the male population, mainly in pediatrics. As this procedure is mainly performed on an outpatient basis, the implementation of an enhanced rehabilitation protocol after surgery in pediatrics helps to reduce the incidence of postoperative pain, notably by providing multimodal analgesia, including locoregional anesthesia. Current recommendations from pediatric locoregional anesthesia societies favor penile block and the use of ultrasound in pediatric anesthesia to reduce anesthetic set-up time and the volume of local anesthetic, but also to increase the duration of sensory block and the success rate. However, several studies have shown the inferiority of penile block in anatomical landmarks compared with pudendal block under neurostimulation. As a result, pediatric anesthesiologists at Caen University Hospital prefer to use pudendal blocks under neurostimulation for posthectomy surgery. To date, no study has compared penile block under ultrasound with pudendal block under neurostimulation for postoperative analgesia after posthectomy surgery. On the other hand, a study of postoperative analgesia in hypospadias surgery showed a clear superiority of penile block under ultrasound over pudendal block in terms of both immediate postoperative pain and duration of postoperative analgesia. It therefore seems pertinent to compare these two techniques in posthectomy surgery.
Objective: We propose a prospective, open-label, non-inferiority study with the primary objective of comparing the efficacy of echo-guided penile block versus pudendal block in neurostimulation for posthectomy surgery.
Read more
Methods: This randomized, single-center study will include 240 patients divided into two groups. The experimental group will receive optimized medical and surgical management, with a penile block under ultrasound, while the control group will receive a pudendal block under neurostimulation. The planned duration of the study is 3 years.
Hypothesis tested: We hypothesize that ultrasound-guided penile block is non-inferior to neurostimulated pudendal block for postoperative analgesia in scheduled posthectomy surgery. The secondary objectives are to evaluate the time taken to perform the block, the volume of local anesthetic used, the need for sufentanil reinjection intraoperatively, the quantitative evaluation of analgesia using the EVENDOL score, the consumption of nalbuphine in the post anesthesia care unit, the occurrence of postoperative vomiting, and the length of stay in the post anesthesia care unit. The rate of complications related to the performance of locoregional anesthesia is also observed.
- Being tested
- Ultrasound guided penile block, Neurostimulation guided pudendal block
- Keywords
- Neurostimulation guided pudendal block, US guided penile block, Security, Efficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided penile blockProcedure or surgery
The penile block is performed supine. After skin disinfection, the Buck's fascia is sonographically located, and the local anesthetic is injected close to the dorsal nerve of the penis in the plane after a negative aspiration test (16). The recommended dose is 0.1 ml/kg per side of ropivacaine 2 mg/ml (8). Injection is performed bilaterally. A subcutaneous injection of 1ml ropivacaine 2mg/ml (i.e. 2mg) is made at the base of the penis to ensure blockage of the perineal fibers.
Neurostimulation guided pudendal blockProcedure or surgery
The pudendal block is performed in the supine position, with the legs flexed. After skin disinfection and palpation of the ischial tuberosity, the neurostimulator needle, set at 0.5 mA, is inserted 1 cm medial to the tuberosity. Contraction of the anal sphincter enables the proximity of the pudendal nerve, originating from the S2, S3 and S4 roots, to be identified. Once contraction has been obtained, local anaesthetic is injected using ropivacaine 2 mg/ml at a dose of 0.2 ml/kg per side, in the absence of blood reflux.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided penile block | Experimental | The penile block is performed supine. After skin disinfection, the Buck's fascia is sonographically located, and the local anesthetic is injected close to the dorsal nerve of the penis in the plane after a negative aspiration test. The recommended dose is 0.1 ml/kg per side of ropivacaine 2 mg/ml. Injection is performed bilaterally. A subcutaneous injection of 1ml ropivacaine 2mg/ml is made at the base of the penis to ensure blockage of the perineal fibers. Receives: Procedure: Ultrasound guided penile block |
| Neurostimulation guided pudendal block | Active comparator | The pudendal block is performed in the supine position, with the legs flexed. After skin disinfection and palpation of the ischial tuberosity, the neurostimulator needle, set at 0.5 mA, is inserted 1 cm medial to the tuberosity. Contraction of the anal sphincter enables the proximity of the pudendal nerve, originating from the S2, S3 and S4 nerve roots, to be identified. Once contraction has been obtained, local anaesthetic is injected using ropivacaine 2 mg/ml at a dose of 0.2 ml/kg per side, in the absence of blood reflux. Receives: Procedure: Neurostimulation guided pudendal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure of effective postoperative analgesia
It is defined by intense postoperative pain: an EVENDOL score ≥ 4 or the use of nalbuphine (0.1 to 0.2 mg/kg discontinuous) in the post anesthesia care unit "EVENDOL" is a French scale, which is an acronym of "EValuation ENfant DOuleur" or "Child pain assessment". This scale goes from 0 to 15, 0 is the absence of pain and 15 is the maximum pain. 4/15 is the threshold from which treatment is indicated.
Measured: Perioperative period : From anesthetic induction to discharge from the post- anesthesia care unit (12 hours maximum)
Secondary outcomes (8)
Locoregional anesthesia completion time
In seconds, defined as the time between the end of skin disinfection and removal of the locoregional anesthesia needle.
Measured: Peroperative period : From the end of skin disinfection to the removal of the locoregional anesthesia needle, assessed up to 30 minutes
Volume of local anesthetic injected
Volume of local anesthetic injected (in mL/kg/side)
Measured: Peroperative period : From skin disinfection to removal of the ALR needle, assessed up to 30 minutes
Intraoperative block failure rate
Block failure is defined by the need to reinject sufentanil intraoperatively when systolic blood pressure or heart rate increases by more than 20% compared with the pre-incision heart rate, necessitating the consumption of intraoperative morphine.
Measured: Peroperative period : From the beginning to the end of the surgery, assessed up to 2 hours
Quantitative assessment of postoperative pain
Quantitative assessment of postoperative pain using the EVENDOL score on arrival in the ICU, H+20 minutes, H+40 minutes and discharge from the post anesthesia care unit.
As a reminder, EVENDOL" is a French scale, which is an acronym of "EValuation ENfant DOuleur" or "Child pain assessment". This scale goes from 0 to 15, 0 is the absence of pain and 15 is the maximum pain. 4/15 is the threshold from which treatment is indicated.
Measured: Immediate post operative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Nalbuphine consumption
Nalbuphine consumption in the post anesthesia care unit (in mg/kg)
Measured: Immediate postoperative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Post operative vomiting
Post operative vomiting and cosumption of ondansetron
Measured: Immediate post operative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Length of stay in post anesthesia care unit
In minutes
Measured: Immediate postoperative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Adverse events related to local anesthesia
Signs of local anesthetic intoxication (neurological signs such as tinnitus, logorrhea or convulsion; tachycardia, hypotension), bleeding and hematoma at puncture site.
Measured: Perioperative period : From the completion of local anesthesia to the discharge from post anesthesia care unit, assessed up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Luc Hanouz, MD, PhD, Study chair, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191938
- Sponsor's protocol ID
- 2024-A01470-47
- Acronym
- PinEAPPLE
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okoro C, Huang H, Cannon S, Low D, Liston DE, Richards MJ, Lendvay TS. The pudendal nerve block for ambulatory urology: What's old is new again. A quality improvement project. J Pediatr Urol. 2020 Oct;16(5):594.e1-594.e7. doi: 10.1016/j.jpurol.2020.07.025. Epub 2020 Jul 24.
PubMed 32819811Boisvert-Moreau F, Turcotte B, Albert N, Singbo N, Moore K, Boivin A. Randomized controlled trial (RCT) comparing ultrasound-guided pudendal nerve block with ultrasound-guided penile nerve block for analgesia during pediatric circumcision. Reg Anesth Pain Med. 2023 Mar;48(3):127-133. doi: 10.1136/rapm-2022-103785. Epub 2022 Nov 17.
PubMed 36396298Gnassingbe K, Akakpo-Numado KG, Anoukoum T, Kanassoua K, Kokoroko E, Tekou H. [The circumcision: why and how is it practiced in the newborn and the infant in the Lome teaching hospital?]. Prog Urol. 2009 Sep;19(8):572-5. doi: 10.1016/j.purol.2009.02.011. Epub 2009 Apr 3. French.
PubMed 19699456Aksu C, Akay MA, Sen MC, Gurkan Y. Ultrasound-guided dorsal penile nerve block vs neurostimulator-guided pudendal nerve block in children undergoing hypospadias surgery: A prospective, randomized, double-blinded trial. Paediatr Anaesth. 2019 Oct;29(10):1046-1052. doi: 10.1111/pan.13727. Epub 2019 Sep 2.
PubMed 31433895Pertek JP, Junke E, Coissard A, Vagner JC, Haberer JP. [Penile block in adults]. Ann Fr Anesth Reanim. 1992;11(1):82-7. doi: 10.1016/S0750-7658(05)80323-5. French.
PubMed 1443819Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth. 2010 Oct;20(10):931-6. doi: 10.1111/j.1460-9592.2010.03405.x.
PubMed 20849498Tutuncu AC, Kendigelen P, Ashyyeralyeva G, Altintas F, Emre S, Ozcan R, Kaya G. Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision. Urol J. 2018 May 3;15(3):109-115. doi: 10.22037/uj.v0i0.4292.
PubMed 29299888Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
PubMed 21790518Beydon L, Ecoffey C, Lienhart A, Puybasset L; Comite ICARE de Societe francaise d'anesthesie et de reanimation (Sfar). [Circumcision in children: an organizational or an ethical challenge?]. Ann Fr Anesth Reanim. 2012 May;31(5):442-6. doi: 10.1016/j.annfar.2012.01.038. Epub 2012 Mar 30. French.
PubMed 22464840
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Echo-guided Penile Block and Pudendal Block Under Neurostimulation for Perioperative Analgesia of Posthectomy in Pediatric Surgery: a Prospective, Randomized Study at Caen University Hospital
- ClinicalTrials.gov ID
- NCT07191938
- Acronym / sponsor ID
- PinEAPPLE / 2024-A01470-47
- Keywords
- Neurostimulation guided pudendal block, US guided penile block, Security, Efficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Sep 2025 (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.
Context : Posthectomy is a surgical procedure that concerns around 30% of the male population, mainly in pediatrics. As this procedure is mainly performed on an outpatient basis, the implementation of an enhanced rehabilitation protocol after surgery in pediatrics helps to reduce the incidence of postoperative pain, notably by providing multimodal analgesia, including locoregional anesthesia. Current recommendations from pediatric locoregional anesthesia societies favor penile block and the use of ultrasound in pediatric anesthesia to reduce anesthetic set-up time and the volume of local anesthetic, but also to increase the duration of sensory block and the success rate. However, several studies have shown the inferiority of penile block in anatomical landmarks compared with pudendal block under neurostimulation. As a result, pediatric anesthesiologists at Caen University Hospital prefer to use pudendal blocks under neurostimulation for posthectomy surgery. To date, no study has compared penile block under ultrasound with pudendal block under neurostimulation for postoperative analgesia after posthectomy surgery. On the other hand, a study of postoperative analgesia in hypospadias surgery showed a clear superiority of penile block under ultrasound over pudendal block in terms of both immediate postoperative pain and duration of postoperative analgesia. It therefore seems pertinent to compare these two techniques in posthectomy surgery.
Objective: We propose a prospective, open-label, non-inferiority study with the primary objective of comparing the efficacy of echo-guided penile block versus pudendal block in neurostimulation for posthectomy surgery.
Methods: This randomized, single-center study will include 240 patients divided into two groups. The experimental group will receive optimized medical and surgical management, with a penile block under ultrasound, while the control group will receive a pudendal block under neurostimulation. The planned duration of the study is 3 years.
Hypothesis tested: We hypothesize that ultrasound-guided penile block is non-inferior to neurostimulated pudendal block for postoperative analgesia in scheduled posthectomy surgery. The secondary objectives are to evaluate the time taken to perform the block, the volume of local anesthetic used, the need for sufentanil reinjection intraoperatively, the quantitative evaluation of analgesia using the EVENDOL score, the consumption of nalbuphine in the post anesthesia care unit, the occurrence of postoperative vomiting, and the length of stay in the post anesthesia care unit. The rate of complications related to the performance of locoregional anesthesia is also observed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided penile block | Experimental | Procedure: Ultrasound guided penile blockThe penile block is performed supine. After skin disinfection, the Buck's fascia is sonographically located, and the local anesthetic is injected close to the dorsal nerve of the penis in the plane after a negative aspiration test. The recommended dose is 0.1 ml/kg per side of ropivacaine 2 mg/ml. Injection is performed bilaterally. A subcutaneous injection of 1ml ropivacaine 2mg/ml is made at the base of the penis to ensure blockage of the perineal fibers. |
| Neurostimulation guided pudendal block | Active comparator | Procedure: Neurostimulation guided pudendal blockThe pudendal block is performed in the supine position, with the legs flexed. After skin disinfection and palpation of the ischial tuberosity, the neurostimulator needle, set at 0.5 mA, is inserted 1 cm medial to the tuberosity. Contraction of the anal sphincter enables the proximity of the pudendal nerve, originating from the S2, S3 and S4 nerve roots, to be identified. Once contraction has been obtained, local anaesthetic is injected using ropivacaine 2 mg/ml at a dose of 0.2 ml/kg per side, in the absence of blood reflux. |
Who may qualify
- Ages
- 12 weeks to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children aged over 3 months or 60 weeks post-conceptional age scheduled for outpatient posthectomy surgery
Key exclusion criteria (6 listed)
- Recent airway infection.
- Contraindication to locoregional anesthesia: infection and/or loss of substance at the puncture site, congenital or acquired coagulopathy, product allergy.
- Contraindication to outpatient treatment: age < 12 weeks for healthy children or 60 weeks corrected age for premature babies, unbalanced pre-existing pathology (respiratory), ability to understand and comply with instructions (pre-operative fasting, taking painkillers at home and resumption of feeding), inability to ensure the presence of 2 adults including 1 parent on the return journey by car for children < 10 years old, easy access to care close to home.
- Emergency surgery.
- Coupled surgery (posthectomy + other surgery).
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 |
|---|---|---|
| Ultrasound guided penile blockThe penile block is performed supine. After skin disinfection, the Buck's fascia is sonographically located, and the local anesthetic is injected close to the dorsal nerve of the penis in the plane after a negative aspiration test (16). The recommended dose is 0.1 ml/kg per side of ropivacaine 2 mg/ml (8). Injection is performed bilaterally. A subcutaneous injection of 1ml ropivacaine 2mg/ml (i.e. 2mg) is made at the base of the penis to ensure blockage of the perineal fibers. | Procedure or surgery | Ultrasound guided penile block |
| Neurostimulation guided pudendal blockThe pudendal block is performed in the supine position, with the legs flexed. After skin disinfection and palpation of the ischial tuberosity, the neurostimulator needle, set at 0.5 mA, is inserted 1 cm medial to the tuberosity. Contraction of the anal sphincter enables the proximity of the pudendal nerve, originating from the S2, S3 and S4 roots, to be identified. Once contraction has been obtained, local anaesthetic is injected using ropivacaine 2 mg/ml at a dose of 0.2 ml/kg per side, in the absence of blood reflux. | Procedure or surgery | Neurostimulation guided pudendal block |
Primary outcome
Failure of effective postoperative analgesia
Time frame: Perioperative period : From anesthetic induction to discharge from the post- anesthesia care unit (12 hours maximum)
It is defined by intense postoperative pain: an EVENDOL score ≥ 4 or the use of nalbuphine (0.1 to 0.2 mg/kg discontinuous) in the post anesthesia care unit "EVENDOL" is a French scale, which is an acronym of "EValuation ENfant DOuleur" or "Child pain assessment". This scale goes from 0 to 15, 0 is the absence of pain and 15 is the maximum pain. 4/15 is the threshold from which treatment is indicated.
8 secondary outcomes
Locoregional anesthesia completion time
Time frame: Peroperative period : From the end of skin disinfection to the removal of the locoregional anesthesia needle, assessed up to 30 minutes
Volume of local anesthetic injected
Time frame: Peroperative period : From skin disinfection to removal of the ALR needle, assessed up to 30 minutes
Intraoperative block failure rate
Time frame: Peroperative period : From the beginning to the end of the surgery, assessed up to 2 hours
Quantitative assessment of postoperative pain
Time frame: Immediate post operative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Nalbuphine consumption
Time frame: Immediate postoperative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Post operative vomiting
Time frame: Immediate post operative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Length of stay in post anesthesia care unit
Time frame: Immediate postoperative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours
Adverse events related to local anesthesia
Time frame: Perioperative period : From the completion of local anesthesia to the discharge from post anesthesia care unit, assessed up to 6 hours
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 25 Sep 2025.
- Background: PubMed 32819811Okoro C, Huang H, Cannon S, Low D, Liston DE, Richards MJ, Lendvay TS. The pudendal nerve block for ambulatory urology: What's old is new again. A quality improvement project. J Pediatr Urol. 2020 Oct;16(5):594.e1-594.e7. doi: 10.1016/j.jpurol.2020.07.025. Epub 2020 Jul 24.
- Background: PubMed 36396298Boisvert-Moreau F, Turcotte B, Albert N, Singbo N, Moore K, Boivin A. Randomized controlled trial (RCT) comparing ultrasound-guided pudendal nerve block with ultrasound-guided penile nerve block for analgesia during pediatric circumcision. Reg Anesth Pain Med. 2023 Mar;48(3):127-133. doi: 10.1136/rapm-2022-103785. Epub 2022 Nov 17.
- Background: PubMed 19699456Gnassingbe K, Akakpo-Numado KG, Anoukoum T, Kanassoua K, Kokoroko E, Tekou H. [The circumcision: why and how is it practiced in the newborn and the infant in the Lome teaching hospital?]. Prog Urol. 2009 Sep;19(8):572-5. doi: 10.1016/j.purol.2009.02.011. Epub 2009 Apr 3. French.
- Background: PubMed 31433895Aksu C, Akay MA, Sen MC, Gurkan Y. Ultrasound-guided dorsal penile nerve block vs neurostimulator-guided pudendal nerve block in children undergoing hypospadias surgery: A prospective, randomized, double-blinded trial. Paediatr Anaesth. 2019 Oct;29(10):1046-1052. doi: 10.1111/pan.13727. Epub 2019 Sep 2.
- Background: PubMed 1443819Pertek JP, Junke E, Coissard A, Vagner JC, Haberer JP. [Penile block in adults]. Ann Fr Anesth Reanim. 1992;11(1):82-7. doi: 10.1016/S0750-7658(05)80323-5. French.
- Background: PubMed 20849498Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth. 2010 Oct;20(10):931-6. doi: 10.1111/j.1460-9592.2010.03405.x.
- Background: PubMed 29299888Tutuncu AC, Kendigelen P, Ashyyeralyeva G, Altintas F, Emre S, Ozcan R, Kaya G. Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision. Urol J. 2018 May 3;15(3):109-115. doi: 10.22037/uj.v0i0.4292.
- Background: PubMed 21790518Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
- Background: PubMed 22464840Beydon L, Ecoffey C, Lienhart A, Puybasset L; Comite ICARE de Societe francaise d'anesthesie et de reanimation (Sfar). [Circumcision in children: an organizational or an ethical challenge?]. Ann Fr Anesth Reanim. 2012 May;31(5):442-6. doi: 10.1016/j.annfar.2012.01.038. Epub 2012 Mar 30. French.
- Individual participant dataSharing planned: No
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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.
Jean Luc Hanouz, MD, PhD study chair
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided penile block and Neurostimulation guided pudendal block in people with Postoperative Care and Analgesia Assessment, run by University Hospital, Caen at 1 site in France.
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 1 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Sep 2025. 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 France. 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 Marine A Rolland, MD (+33699014734, rolland-m@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure of effective postoperative analgesia (time frame: Perioperative period : From anesthetic induction to discharge from the post- anesthesia care unit (12 hours maximum)). 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 NCT07191938, which also lists 9 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 25 Sep 2025.