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

7 мая 2026 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Процедура: 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.
Активный компаратор: 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
Процедура: 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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Postoperative pain intensity by using Face, Leg, Activity, Cry, Consolability (FLACC) scale
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Time to First Postoperative Analgesic Requirement
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Bangladesh Medical University

Следователи

  • Директор по исследованиям: AKM Akhtaruzzaman, MD, Bangladesh Medical University

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 мая 2025 г.

Первичное завершение (Действительный)

31 марта 2026 г.

Завершение исследования (Действительный)

31 марта 2026 г.

Даты регистрации исследования

Первый отправленный

4 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

4 мая 2026 г.

Первый опубликованный (Действительный)

8 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

12 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

7 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • #5734

Планирование данных отдельных участников (IPD)

Данные исследования/документы

  1. Протокол исследования
    Информационный идентификатор: pain.medicine@bsmmu.edu.bd

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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