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Ultrasound-Guided Pudendal vs Dorsal Penile Nerve Block for Pediatric Hypospadias Surgery

7 maggio 2026 aggiornato da: Kazi Mahzabin Arin, Bangladesh Medical University

Effectiveness of Ultrasound-Guided Pudendal Versus Dorsal Penile Nerve Block for Postoperative Analgesia in Paediatric Hypospadias Surgery

The goal of this clinical trial is to compare the effectiveness and safety of two regional anesthesia techniques, ultrasound-guided pudendal nerve block and dorsal penile nerve block, for postoperative pain management in children undergoing hypospadias surgery.

The main questions we aim to answer are:

Which technique provides more effective pain relief after surgery? What are the potential side effects or complications associated with each technique?

Participants will:

Receive either an Ultrasound-guided pudendal nerve block or a dorsal penile nerve block in combination with general anesthesia after surgery.

Participants will be monitored for pain levels using a pediatric pain scale Face, Leg, Activity, Cry, Consolability (FLACC) and their overall recovery for the first 24 hours post-surgery.

Have their total analgesic consumption and vital signs recorded during the recovery period.

This study will help improve postoperative pain management strategies for pediatric hypospadias surgery by evaluating these two anesthesia techniques.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This randomized controlled trial aims to evaluate and compare the efficacy of ultrasound-guided pudendal nerve block (USG-PNB) and dorsal penile nerve block (DPNB) for postoperative analgesia in pediatric patients undergoing hypospadias repair surgery. Both techniques are regional anesthesia methods used to manage postoperative pain, but they differ in the sensory regions they target. The study seeks to determine which of these two techniques provides more effective pain relief and assess any associated complications.

A total of 60 pediatric patients, aged 1 to 6 years, undergoing hypospadias surgery under general anesthesia will be enrolled. Patients will be randomly assigned to receive either the USG-PNB or DPNB after induction of anesthesia. The primary outcome of the study is the first postoperative analgesic requirement, measured using the Face, Leg, Activity, Cry, Consolability (FLACC) pain scale. Secondary outcomes include time to first analgesic requirement, postoperative pain intensity at different time points, total analgesic consumption within the first 24 hours, and the monitoring of hemodynamic parameters, including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and complications related to either nerve block technique.

Patients will be monitored in the post-anesthetic care unit for 24 hours, during which pain levels and vital signs will be recorded.

By comparing the two regional anesthesia techniques, this study will contribute to improving postoperative pain management strategies, with a focus on minimizing side effects and improving recovery times in pediatric patients undergoing hypospadias surgery.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangladesh Medical University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Patients aged 1 to 6 years.
  • Scheduled for hypospadias surgery under general anesthesia.
  • American Society of Anesthesiologists (ASA) physical status I or II (healthy children or those with mild systemic disease).
  • Parents or legal guardians willing to provide written informed consent.
  • Patients who meet the study's medical and surgical eligibility after pre-anesthetic evaluation.

Exclusion Criteria:

  • Allergy to local anesthetics (e.g., bupivacaine).
  • Patient or parent refusal to participate.
  • Local infection or inflammation at the site of Block placement.
  • Anatomical deformities that may interfere with the Block administration.
  • Coagulopathy or bleeding disorders.
  • Severe systemic conditions (e.g., ASA physical status III or IV).
  • History of adverse reactions to nerve blocks or regional anesthesia.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Ultrasound-Guided Pudendal Nerve Block Group
In this arm, participants will receive ultrasound-guided pudendal nerve block (PNB) for postoperative pain management following hypospadias surgery. The procedure involves the administration of 0.25% bupivacaine (0.2-0.5 mL/kg) mixed with 0.05 mg/kg dexamethasone to block the pudendal nerve. The block will be performed under direct ultrasound visualization after induction of general anesthesia, targeting the perineal area, including both superficial and deeper penile tissues. The effects of this intervention will be compared to the dorsal penile nerve block group in terms of postoperative pain relief and analgesic consumption.
Procedura: Ultrasound-Guided Pudendal Nerve Block
This intervention involves the use of ultrasound guidance to perform a pudendal nerve block for postoperative pain relief in pediatric patients undergoing hypospadias surgery. The procedure targets the pudendal nerve, which provides sensory innervation to the perineal area, including the genitalia. The block is performed by injecting a mixture of 0.25% bupivacaine and dexamethasone under ultrasound visualization, ensuring precise placement of the needle. This method aims to provide comprehensive analgesia for both superficial and deeper tissues, reducing the need for additional systemic analgesics and improving postoperative recovery.
Comparatore attivo: Ultrasound-Guided Dorsal Penile Nerve Block Group

Ultrasound-Guided Dorsal Penile Nerve Block Group:

In this arm, participants will receive ultrasound-guided dorsal penile nerve block (DPNB) for postoperative pain management following hypospadias surgery. The procedure involves the administration of 0.25% bupivacaine (0.5 mL/kg) mixed with 0.05 mg/kg dexamethasone, targeting the dorsal penile nerve. The block will be performed under direct ultrasound visualization at the penoscrotal junction, focusing on the distal penile region. The effects of this intervention will be compared to the pudendal nerve block group in terms of postoperative pain relief and analgesic consumption
Procedura: Ultrasound-Guided Dorsal Penile Nerve Block
This intervention involves the use of ultrasound guidance to perform a dorsal penile nerve block for postoperative pain management in pediatric patients undergoing hypospadias surgery. The procedure targets the dorsal penile nerve, which innervates the distal part of the penis. Under ultrasound visualization, a mixture of 0.25% bupivacaine and dexamethasone is injected near the nerve to provide localized analgesia. This block is designed to alleviate pain in the distal penile area but may not offer as broad a sensory coverage as the pudendal nerve block, particularly for deeper tissues.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative pain intensity by using Face, Leg, Activity, Cry, Consolability (FLACC) scale
Lasso di tempo: From the end of surgery to 24 hours post-surgery This includes assessments of postoperative pain intensity using the FLACC scale at various time points, starting immediately after surgery and continuing at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery

The primary outcome measure of this study is the postoperative pain intensity, which will be assessed using the Face, Leg, Activity, Cry, Consolability (FLACC) scale. This scale is designed to evaluate pain in young children who cannot verbally communicate their discomfort. It consists of five categories:

Face: The facial expression of the child (e.g., no expression, occasional grimace, or frequent grimace).

Legs: The position of the child's legs (e.g., relaxed, tense, or kicking). Activity: The child's level of activity (e.g., lying quietly, squirming, or arching).

Cry: The type and frequency of crying (e.g., no cry, occasional complaints, or crying steadily).

Consolability: How easily the child can be comforted (e.g., content, reassured by touch, or difficult to console).

Each category is scored from 0 to 2, with a total score ranging from 0 to 10. A higher score indicates higher pain intensity.
From the end of surgery to 24 hours post-surgery This includes assessments of postoperative pain intensity using the FLACC scale at various time points, starting immediately after surgery and continuing at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to First Postoperative Analgesic Requirement
Lasso di tempo: From the end of surgery to the first analgesic requirement, within the first 24 hours post-surgery.
This outcome measures the time interval from the end of surgery to the first request for analgesic medication postoperatively. It is a key indicator of how long the nerve block techniques provide effective pain relief before additional pain medication is required.
From the end of surgery to the first analgesic requirement, within the first 24 hours post-surgery.
Total Postoperative Analgesic Consumption in the First 24 Hours
Lasso di tempo: From the end of surgery to 24 hours post-surgery, with total analgesic consumption recorded at regular intervals.
This outcome measures the total amount of postoperative analgesic medication (including paracetamol, NSAIDs, and any rescue analgesics) consumed by patients during the first 24 hours after surgery. The purpose is to evaluate the effectiveness of the nerve block techniques in reducing the need for additional pain relief.
From the end of surgery to 24 hours post-surgery, with total analgesic consumption recorded at regular intervals.
Hear rate (HR)
Lasso di tempo: From the end of surgery to 24 hours post-surgery, with heart rate recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
This outcome measures the heart rate of the patient postoperatively. Monitoring heart rate helps assess the cardiovascular stability of the patient after surgery and anesthesia.
From the end of surgery to 24 hours post-surgery, with heart rate recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
Systolic Blood Pressure (SBP)
Lasso di tempo: From the end of surgery to 24 hours post-surgery, with systolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
This outcome measures the systolic blood pressure of the patient postoperatively. It helps evaluate the impact of the nerve block techniques on the patient's blood pressure and circulatory status.
From the end of surgery to 24 hours post-surgery, with systolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
Diastolic Blood Pressure (DBP)
Lasso di tempo: From the end of surgery to 24 hours post-surgery, with diastolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
This outcome measures the diastolic blood pressure of the patient postoperatively. It provides additional insight into the patient's cardiovascular status and response to anesthesia and the nerve block techniques
From the end of surgery to 24 hours post-surgery, with diastolic blood pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
Mean Arterial Pressure (MAP)
Lasso di tempo: From the end of surgery to 24 hours post-surgery, with mean arterial pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
This outcome measures the mean arterial pressure, which is an important indicator of the perfusion pressure and the overall stability of the patient's cardiovascular system after surgery. It reflects the pressure necessary to ensure adequate blood flow to organs and tissues.
From the end of surgery to 24 hours post-surgery, with mean arterial pressure recorded immediately after surgery, and then at 1, 2, 4, 6, 8, 12, and 24 hours post-surgery.
Complications related to nerve block
Lasso di tempo: From the end of surgery to 24 hours post-surgery, with any complications or adverse events documented during the recovery period.
This outcome involves the monitoring and recording of any complications or adverse effects associated with either the ultrasound-guided pudendal nerve block or dorsal penile nerve block. This includes, but is not limited to, issues such as infection, hematoma formation, nerve injury, or systemic reactions to the anesthetics.
From the end of surgery to 24 hours post-surgery, with any complications or adverse events documented during the recovery period.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bangladesh Medical University

Investigatori

  • Direttore dello studio: AKM Akhtaruzzaman, MD, Bangladesh Medical University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2025

Completamento primario (Effettivo)

31 marzo 2026

Completamento dello studio (Effettivo)

31 marzo 2026

Date di iscrizione allo studio

Primo inviato

4 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • #5734

Piano per i dati dei singoli partecipanti (IPD)

Dati/documenti di studio

  1. Protocollo di studio
    Identificatore informazioni: pain.medicine@bsmmu.edu.bd

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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