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Набор по приглашению NCT07618650

Ultrasound-Guided Transversalis Fascia Plane Block Versus Quadratus Lumborum Plane Block for Analgesia After Appendectomy in Pediatrics

Без фазы С лечением Transversalis Fascia Plane Block Quadratus Lumborum Block Appendectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transversalis Fascia Plane Block group, Quadratus Lumborum Plane Block group.
Кому может быть актуально
Состояния в реестре: Transversalis Fascia Plane Block, Quadratus Lumborum Block, Appendectomy. Базовые параметры: 7 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Официальное название

Ultrasound-Guided Transversalis Fascia Plane Block Versus Quadratus Lumborum Plane Block for Analgesia After Appendectomy in Pediatrics: A Prospective Randomized Study

Обзор

This study aims to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy. Primary outcomes: • Proportion of patients needing rescue analgesia within the first 24 postoperative hours. Secondary outcomes: * Visual Analogue Scale pain intensity measurements. * Intraoperative Heart rate and mean arterial blood pressure will be recorded. * Time to first analgesic request for patients needing rescue analgesia (Fentanyl). * Block-related complications (e.g., hematoma, local anesthetic toxicity, lower limb weakness). * Parents' satisfaction score.

Подробное описание

Appendicectomy is amongst the most commonly performed surgery, with acute appendicitis being the most frequent reason for abdominal surgical emergencies in the world . The lifetime risk of appendicitis is 7-8%, with rising incidence in the newly industrialized countries . The prevailing treatment of choice for appendicitis is appendicectomy, which can be performed either 'open' or laparoscopically .

A major contributor to the pain experienced by a patient after abdominal surgery is the incision made in the abdominal wall . Almost 80% of patients undergoing surgery experience postoperative pain, and 80% of them reported moderate-to-severe pain intensity .

Traditional methods of postoperative pain management in children, such as systemic opioids and nonsteroidal anti-inflammatory drugs , may not always provide adequate relief, especially for more invasive procedures . These approaches can also be associated with side effects like sedation, nausea, and respiratory depression, which may complicate postoperative care and recovery . In recent years, regional anesthesia techniques have emerged as promising alternatives for postoperative pain management in various surgical populations Two specific regional blocks that have gained attention for their potential benefits in reducing postoperative pain after abdominal surgeries is the Quadratus Lumborum Block and the Transversus Facial Abdominal Plane block The Quadratus Lumborum Block targets the nerves supplying the lumbar plexus, providing analgesia to the anterior abdominal wall . It has been shown to be effective in adult patients undergoing lower abdominal surgery, offering improved postoperative pain scores and reduced opioid consumption compared to traditional pain management strategies .

Although, both Quadratus Lumborum Block and Transversus Facial Abdominal Plane block are frequently employed in pediatric anesthesia, evidence to guide clinical decisions on which block offers superior outcomes needs to be comprehensively reviewed. We aimed to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.

This study aims to compare the effectiveness of ultrasound-guided Transversalis Fascia Plane block versus Quadratus Lumborum block for postoperative pain relief in pediatrics undergoing appendectomy.

Primary outcomes:

• Proportion of patients needing rescue analgesia within the first 24 postoperative hours.

Secondary outcomes:

* Visual Analogue Scale pain intensity measurements. * Intraoperative Heart rate and mean arterial blood pressure will be recorded. * Time to first analgesic request for patients needing rescue analgesia (Fentanyl). * Block-related complications (e.g., hematoma, local anesthetic toxicity, lower limb weakness). * Parents' satisfaction score.

Вмешательства

  • Процедура Transversalis Fascia Plane Block group
    35 Patients will receive general anesthesia and ultrasound-guided transversalis fascia plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision.
  • Процедура Quadratus Lumborum Plane Block group
    35 patients will receive general anesthesia and a quadratus lumborum plane block in a dose of 0.4 ml/kg of 0.25% bupivacaine administered prior to surgical excision

Первичные конечные точки

  • Proportion of patients needing rescue analgesia [Срок оценки: within the first 24 postoperative hours.]
Вторичные конечные точки (1)
  • Visual Analogue Scale [Срок оценки: 24 postoperative hours]

Критерии участия

Критерии включения

  • 70 patients aged between 7 and 12 years of both sexes undergoing appendectomy, American Society of Anesthesiologists (ASA) physical status of I or II

Критерии исключения

  • Refusal of parents to participate
  • Patients with peritonitis
  • History of allergy to bupivacaine and other amide local anesthetics
  • Infection at the site of block needle entry
  • Bleeding diathesis
  • Neurological disorders
  • American Society of Anesthesiologists ≥ III

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Египет · 1 центр
  • Tanta University — Tanta

Идентификаторы

NCT: NCT07618650 · 36264MS975/6/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗