Posthectomy in Pediatric Elective Surgery : a Comparison of Perioperative Analgesia Using Echo-guided Penile Block and Pudendal Block With neurostimuLation Technique

NCT ID: NCT07191938

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-12-31

Brief 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, 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.

Conditions

Postoperative Care; Analgesia Assessment; Posthectomy; Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Ultrasound guided penile block

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.

Group Type: EXPERIMENTAL

Ultrasound guided penile block

Intervention Type: PROCEDURE

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 block

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.

Group Type: ACTIVE_COMPARATOR

Neurostimulation guided pudendal block

Intervention Type: PROCEDURE

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.

Interventions

Ultrasound guided penile block

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.

Intervention Type: PROCEDURE

Neurostimulation guided pudendal block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All children aged over 3 months or 60 weeks post-conceptional age scheduled for outpatient posthectomy surgery

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Weeks
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Luc Hanouz, MD, PhD

Role: STUDY_CHAIR

University Hospital, Caen

Locations

CHU de Caen

Caen, Normandy, France

Countries

France

Central Contacts

Marine A Rolland, MD

Role: CONTACT

rolland-m@chu-caen.fr

+33699014734

Jean Luc Hanouz, MD, PhD

Role: CONTACT

hanouz-jl@chu-caen.fr

+33231063106

Facility Contacts

Marine A Rolland, MD

Role: primary

rolland-m@chu-caen.fr

+33699014734

References

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Reference Type: BACKGROUND

PMID: 32819811 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 36396298 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 19699456 (View on PubMed)

Aksu 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.

Reference Type: BACKGROUND

PMID: 31433895 (View on PubMed)

Pertek 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.

Reference Type: BACKGROUND

PMID: 1443819 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 20849498 (View on PubMed)

Tutuncu 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.

Reference Type: BACKGROUND

PMID: 29299888 (View on PubMed)

Naja 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.

Reference Type: BACKGROUND

PMID: 21790518 (View on PubMed)

Beydon 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.

Reference Type: BACKGROUND

PMID: 22464840 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

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Other Identifiers

2024-A01470-47

Identifier Type: -

Identifier Source: org_study_id