- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07602179
Analgesic Efficacy and Hemodynamic Stability of Ultrasound-guided Thoracic Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Pediatric Thoracic Surgery: a Randomized Controlled Trial.
Обзор исследования
Статус
Условия
Подробное описание
This prospective, single-center, randomized controlled trial was conducted in the Department of Anesthesiology at Vietnam National Children's Hospital between January 2024 and December 2024 after approval by the institutional review board. Written informed consent was obtained from the patients' parents or legal guardians before enrollment. The study was conducted in accordance with the Declaration of Helsinki and reported following the CONSORT guidelines.
Children aged 4-16 years with ASA physical status I-II undergoing elective unilateral thoracic surgery under general anesthesia were enrolled. Eligible procedures included surgery for pulmonary cysts, mediastinal tumors, diaphragmatic hernia, lung tumors, and chest wall tumors. Patients with allergy to local anesthetics, significant hepatic, renal, or cardiovascular disease, coagulation disorders, untreated hypovolemia, infection at the puncture site, spinal or chest wall deformities, or paravertebral tumors near the puncture level were excluded. Patients were withdrawn if consent was withdrawn, if major intraoperative bleeding (>20 mL/kg) occurred, or if conversion to median sternotomy was required.
After enrollment, patients were randomly assigned in a 1:1 ratio to one of the following study groups:
- ESPB group: After induction of general anesthesia, patients underwent ultrasound-guided erector spinae plane block at the T5-T6 or T6-T7 level using a high-frequency linear probe. Following hydrodissection confirmation, 0.25% levobupivacaine (0.3 mL/kg, maximum 20 mL) was injected and a catheter was inserted for continuous postoperative analgesia.
- TEA group: After induction of general anesthesia, patients underwent thoracic epidural catheter placement at the T5-T6 or T6-T7 interspace using the loss-of-resistance technique with a Tuohy needle. After confirmation of correct placement, 0.25% levobupivacaine (0.3 mL/kg, maximum 20 mL) was administered through the epidural catheter.
General anesthesia was induced with midazolam (0.03 mg/kg), fentanyl (2 µg/kg), propofol (3 mg/kg), and atracurium (0.6 mg/kg). Following endotracheal intubation, mechanical ventilation was adjusted to maintain EtCO₂ between 30-40 mmHg. One-lung ventilation was established using an Arndt bronchial blocker under fiberoptic guidance. Anesthesia was maintained with sevoflurane in an oxygen-air mixture to maintain a bispectral index between 40 and 60. Additional fentanyl (1 µg/kg) was administered when heart rate or blood pressure increased by more than 20% from baseline values despite adequate anesthetic depth. At the end of surgery, all patients received intravenous paracetamol (15 mg/kg). Postoperative pain was assessed using the Faces Pain Scale-Revised (FPS-R) at rest and during movement. Multimodal analgesia included paracetamol every 6 hours and continuous infusion of 0.125% levobupivacaine via catheter. If FPS-R scores were ≥4, a bolus dose of levobupivacaine was administered through the catheter. Intravenous morphine (0.05 mg/kg) was used as rescue analgesia when pain remained uncontrolled
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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-
Hanoi
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Hanoi, Hanoi, Вьетнам, 100000
- Department of Anesthesiology, Vietnam National Children's Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-II.
- Diagnosis of pulmonary cyst, mediastinal tumor, diaphragmatic hernia, lung tumor, or chest wall tumor requiring unilateral thoracic surgery.
Exclusion Criteria:
- Known allergy to local anesthetics;
- Significant hepatic, renal, or cardiovascular disease;
- Coagulation disorders or untreated hypovolemia;
- Infection at the puncture site;
- Spinal or chest wall deformity or paravertebral tumors near the puncture level.
- Patients were withdrawn from the study if consent was withdrawn, if major intraoperative complications occurred such as massive bleeding (>20 mL/kg), or if conversion to median sternotomy was required during surgery.
- Patient's parents who do not consent to participate in the study
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Thoracic erector spinae plane block (ESPB
Patients will receive ultrasound-guided thoracic ESPB before surgical incision.
After induction of general anesthesia, a high-frequency linear ultrasound probe will be used to identify the transverse process and erector spinae muscle at the appropriate thoracic level.
A bolus dose of levobupivacaine 0.25% at 0.3 mL/kg will be injected into the erector spinae plane, followed by catheter placement for continuous postoperative analgesia.
Continuous infusion of levobupivacaine 0.125% at 0.2 mL/kg/h will be maintained for 72 postoperative hours.
|
Patients will receive ultrasound-guided thoracic ESPB before surgical incision.
After induction of general anesthesia, a high-frequency linear ultrasound probe will be used to identify the transverse process and erector spinae muscle at the appropriate thoracic level.
A bolus dose of levobupivacaine 0.25% at 0.3 mL/kg will be injected into the erector spinae plane, followed by catheter placement for continuous postoperative analgesia.
Continuous infusion of levobupivacaine 0.125% at 0.2 mL/kg/h will be maintained for 72 postoperative hours.
|
|
Активный компаратор: Thoracic epidural analgesia (TEA)
Patients will receive thoracic epidural analgesia before surgical incision.
After induction of general anesthesia, an epidural catheter will be inserted at the thoracic level under sterile conditions using the loss-of-resistance technique.
A bolus dose of levobupivacaine 0.25% at 0.3 mL/kg will be administered via the epidural catheter, followed by continuous postoperative infusion of levobupivacaine 0.125% at 0.2 mL/kg/h for 72 postoperative hours
|
Patients will undergo thoracic epidural catheter placement for perioperative analgesia.
Continuous epidural infusion of levobupivacaine will be maintained for 72 hours postoperatively
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Cumulative opioid consumption within the first 72 postoperative hours
Временное ограничение: From induction of anesthesia until 72 hours postoperatively
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Total opioid consumption included intraoperative fentanyl and postoperative rescue morphine administration.
Intraoperative fentanyl consumption was recorded during surgery, while rescue morphine was administered when postoperative FPS-R score at rest ≥4 despite rescue local anesthetic bolus
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From induction of anesthesia until 72 hours postoperatively
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postoperative pain scores
Временное ограничение: at 1hour, 2hour, 4hour, 8hour, 12hour, 18hour, 24hour, 30hour, 36hour, 42hour, 48hour, 54hour, 60hour and 72hour after surgery
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Postoperative pain was assessed using the Faces Pain Scale-Revised (FPS-R) at rest and during movement at predefined postoperative time points
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at 1hour, 2hour, 4hour, 8hour, 12hour, 18hour, 24hour, 30hour, 36hour, 42hour, 48hour, 54hour, 60hour and 72hour after surgery
|
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Rescue analgesic requirement
Временное ограничение: Within 72 hours postoperatively
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The number of patients requiring rescue morphine and total rescue morphine consumption were recorded
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Within 72 hours postoperatively
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Block-related characteristics
Временное ограничение: During block performance and surgery
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Block failure was defined as intraoperative fentanyl requirement >4 mcg/kg.
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During block performance and surgery
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Catheter-related complications
Временное ограничение: Within 72 hours postoperatively
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Catheter dislodgement, catheter occlusion, vascular puncture, and other catheter-related adverse events were recorded
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Within 72 hours postoperatively
|
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Postoperative complications and adverse events
Временное ограничение: Within 72 hours postoperatively
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Postoperative nausea and vomiting, urinary retention, pruritus, tremor, respiratory complications, and other adverse events were evaluated
|
Within 72 hours postoperatively
|
Соавторы и исследователи
Спонсор
Соавторы
Публикации и полезные ссылки
Общие публикации
- Aksu C, Gurkan Y. Defining the Indications and Levels of Erector Spinae Plane Block in Pediatric Patients: A Retrospective Study of Our Current Experience. Cureus. 2019 Aug 8;11(8):e5348. doi: 10.7759/cureus.5348.
- Bosenberg A. Erector spinae plane blocks: A narrative update. Paediatr Anaesth. 2024 Mar;34(3):212-219. doi: 10.1111/pan.14800. Epub 2023 Nov 16.
- Marhofer P, Zadrazil M, Opfermann PL. Pediatric Regional Anesthesia: A Practical Guideline for Daily Clinical Practice. Anesthesiology. 2025 Aug 1;143(2):444-461. doi: 10.1097/ALN.0000000000005554. Epub 2025 Jun 17.
- Singh S, Andaleeb R, Lalin D. Can ultrasound-guided erector spinae plane block replace thoracic epidural analgesia for postoperative analgesia in pediatric patients undergoing thoracotomy? A prospective randomized controlled trial. Ann Card Anaesth. 2022 Oct-Dec;25(4):429-434. doi: 10.4103/aca.aca_269_20.
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Боль
- Неврологические проявления
- Послеоперационные осложнения
- Патологические процессы
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Боль, Послеоперационный
- Диета, еда и питание
- Физиологические явления
- Еда и напитки
- Напитки
- Подготовка растений
- Биологические продукты
- Сложные смеси
- Чай
Другие идентификационные номера исследования
- HungGMHS/No218
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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