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

NCT07191938 | Not Yet Recruiting

• 1 other identifier: 2024-A01470-47
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Keywords

Neurostimulation guided pudendal block; US guided penile block; Security; Efficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  Perioperative period : From anesthetic induction to discharge from the post- anesthesia care unit (12 hours maximum)

Secondary Outcomes (8)

• Locoregional anesthesia completion time

  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

  Peroperative period : From skin disinfection to removal of the ALR needle, assessed up to 30 minutes

• Intraoperative block failure rate

  Peroperative period : From the beginning to the end of the surgery, assessed up to 2 hours

• Quantitative assessment of postoperative pain

  Immediate post operative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours

• Nalbuphine consumption

  Immediate postoperative period : From the arrival to the discharge from the post anesthesia care unit, assessed up to 4 hours

Study Arms (2)

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.

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.

Procedure: Neurostimulation guided pudendal block

Interventions

Ultrasound guided penile block 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.

Ultrasound guided penile block

Neurostimulation guided pudendal block 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.

Neurostimulation guided pudendal block

Eligibility Criteria

• Age: 12 Weeks - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

CHU de Caen

Caen, Normandy, 14000, France

Location

Related Publications (9)

• 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.

  PMID: 32819811 BACKGROUND

• Boisvert-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.

  PMID: 36396298 BACKGROUND

• Gnassingbe 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.

  PMID: 19699456 BACKGROUND

• 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.

  PMID: 31433895 BACKGROUND

• 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.

  PMID: 1443819 BACKGROUND

• Faraoni 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.

  PMID: 20849498 BACKGROUND

• 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.

  PMID: 29299888 BACKGROUND

• 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.

  PMID: 21790518 BACKGROUND

• 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.

  PMID: 22464840 BACKGROUND

Study Officials

• Jean Luc Hanouz, MD, PhD

  University Hospital, Caen

  STUDY CHAIR

Central Study Contacts

Marine A Rolland, MD

CONTACT

+33699014734; rolland-m@chu-caen.fr

Jean Luc Hanouz, MD, PhD

CONTACT

+33231063106; hanouz-jl@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: September 25, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)