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

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

Overview

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.

Interventions

• Procedure 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.
• 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

Primary outcome measures

• Failure of effective postoperative analgesia [Time frame: Perioperative period : From anesthetic induction to discharge from the post- anesthesia care unit (12 hours maximum)]

Secondary outcome measures (8)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• CHU de Caen — Caen

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. PMID 32819811
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07191938 · 2024-A01470-47

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗