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Идёт набор NCT07242196

Transversalis Fascia Plane Versus Transversus Abdominis Plane Block for Postoperative Analgesia in Children

Наблюдательное Postoperative Analgesia Transversus Abdominis Plane (TAP) Block Transversalis Fascia Plane Block Pediatric Surgical Procedures

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: Postoperative analgesia.
Кому может быть актуально
Состояния в реестре: Postoperative Analgesia, Transversus Abdominis Plane (TAP) Block, Transversalis Fascia Plane Block, Pediatric Surgical Procedures. Базовые параметры: 6 мес. — 16 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Comparison of the Analgesic Effects of Ultrasound-Guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block in Pediatric Laparoscopic Surgery

Обзор

This prospective clinical study aims to compare the postoperative analgesic efficacy of the ultrasound-guided transversalis fascia plane block (TFPB) and the transversus abdominis plane (TAP) block in pediatric patients undergoing laparoscopic surgery. Effective and long-lasting postoperative analgesia is essential for patient and parental satisfaction in pediatric anesthesia. With recent advances in ultrasound technology, regional anesthesia techniques have become increasingly utilized in pediatric practice. In the TAP block, local anesthetic is injected between the internal oblique and transversus abdominis muscles, providing analgesia typically between Torachal vertebra 10 (T10) and Lumbar vertebra (L1) dermatomes. The transversalis fascia plane block, developed as a modification of this approach, targets the proximal portions of the T12 and L1 nerves by depositing local anesthetic between the transversus abdominis muscle and the transversalis fascia, potentially offering wider sensory coverage. This study compares both blocks in terms of postoperative pain scores, duration of analgesia, and requirement for rescue analgesics in children undergoing laparoscopic surgery. The results are expected to contribute to the optimization of regional anesthesia techniques and improve pain management strategies in pediatric surgical patients.

Подробное описание

In pediatric anesthesia, achieving effective and long-lasting analgesia is essential for ensuring the satisfaction of both pediatric patients and their parents. To guarantee this, many pediatric anesthesiologists have incorporated various regional anesthesia techniques into their daily clinical practice. Advances in technology have enabled the use of many regional anesthesia techniques across diverse clinical settings.

The transversus abdominis plane (TAP) block is an interfascial plane block technique in which a local anesthetic is typically administered, under ultrasound guidance, between the internal oblique and transversus abdominis muscles. Although several approaches have been described for this block, all involve the injection of anesthetic into this interfascial layer, providing analgesia from the T10 to L1 dermatomes. With the widespread adoption of ultrasound technology in pediatric practice, this technique and related fascial plane blocks have become increasingly popular.

The transversalis fascia plane (TFP) block was developed as a technique aiming to block more thoracic nerves. In this approach, local anesthetic is injected between the transversus abdominis muscle and the deep transversalis fascia at the level of the posterior axillary line, targeting the proximal portions of the T12 and L1 nerves. The blockade extends medially toward the inner surface of the quadratus lumborum muscle, thereby providing a more effective block of the anterolateral abdominal wall.

The aim of this study is to compare the postoperative analgesic efficacy of ultrasound-guided transversalis fascia plane block and transversus abdominis plane block in pediatric patients undergoing laparoscopic surgery. The primary outcome of the study is the evaluation of postoperative pain using validated pediatric pain assessment scales at defined postoperative intervals. The secondary outcomes include the assessment of additional analgesic requirements, the duration of postoperative analgesia provided by each block, and any block-related complications. Furthermore, this research aims to enhance knowledge regarding regional anesthesia applications in pediatric patients and provide scientific contributions to clinical practice.

Вмешательства

  • Другое Postoperative analgesia
    Postoperative analgesia will be assessed using the Visual Analog Scale (VAS) at predefined time points following surgery: 1, 2, 4, 8, 12, and 24 hours postoperatively. Pain evaluation will be performed both at rest and during movement (e.g., coughing or mobilization). Additional analgesics will be administered according to a standardized protocol: intravenous paracetamol (15 mg/kg/dose, every 6 hours as needed) will be given if VAS ≥ 4. Rescue analgesia requirements, including timing and dosage

Первичные конечные точки

  • Postoperative Pain Assessment (Visuel Analog Scale) [Срок оценки: At 1, 2, 4, 8, 12, and 24 hours after surgery.]
Вторичные конечные точки (4)
  • Duration of Analgesia [Срок оценки: 24 hours after surgery]
  • Rescue Analgesic Requirement [Срок оценки: 24 hours after surgery]
  • Incidence of Block-Related Complications [Срок оценки: 24 hours after surgery]
  • Patient and Parental Satisfaction [Срок оценки: 24 hours after surgery]

Критерии участия

Критерии включения

  • Pediatric patients aged 6 months to 16 years
  • Classified as ASA physical status I or II
  • Scheduled to undergo laparoscopic surgery under general anesthesia

Критерии исключения

  • Patients classified as ASA physical status III or IV
  • Known allergy or hypersensitivity to local anesthetic agents
  • Presence of bleeding diathesis or coagulation disorders
  • Infection at the injection site or local skin lesions preventing block application

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Sakarya University-Anesthesiology and Reanimation Department — Sakarya

Публикации

  • Fredrickson MJ, Paine C, Hamill J. Improved analgesia with the ilioinguinal block compared to the transversus abdominis plane block after pediatric inguinal surgery: a prospective randomized trial. Paediatr Anaesth. 2010 Nov;20(11):1022-7. doi: 10.1111/j.1460-9592.2010.03432.x. PMID 20964768

Идентификаторы

NCT: NCT07242196 · E-43012747-050.04-513206-484

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗