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NCT Number: NCT07191938

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

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.

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Key information

Conditions

Postoperative Care Analgesia Assessment Posthectomy Postoperative Analgesia

Age range

12 week–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Caen

Caen, Normandy, 14000, France

Location contact

Marine A Rolland, MD

CONTACT

[email protected]

+33699014734

Marine A Rolland, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    In seconds, defined as the time between the end of skin disinfection and removal of the locoregional anesthesia needle.

  2. Volume of local anesthetic injected

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

    Volume of local anesthetic injected (in mL/kg/side)

  3. Intraoperative block failure rate

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

    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.

  4. 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

    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.

  5. Nalbuphine consumption

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

    Nalbuphine consumption in the post anesthesia care unit (in mg/kg)

  6. 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

    Post operative vomiting and cosumption of ondansetron

  7. 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

    In minutes

  8. 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

    Signs of local anesthetic intoxication (neurological signs such as tinnitus, logorrhea or convulsion; tachycardia, hypotension), bleeding and hematoma at puncture site.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Luc Hanouz, MD, PhD

CONTACT

[email protected]

+33231063106

Marine A Rolland, MD

CONTACT

[email protected]

+33699014734

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study 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

Acronym: PinEAPPLE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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