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Набор по приглашению NCT06948253

Comparing Postoperative Analgesic Techniques for Umbilical Hernia Repair: A Randomized Trial of Ultrasound Guided Caudal, Erector Spinae, and External Oblique Interfascial Plane Blocks

Без фазы С лечением Regional Anesthesia

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: Erector Spinae Plane Block, Caudal Block Anesthesia, External Oblique Intercostal Plane Block.
Кому может быть актуально
Состояния в реестре: Regional Anesthesia. Базовые параметры: 2 лет — 7 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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Обзор

The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus external oblique intercostal plane block perioperatively

Подробное описание

umblical hernia repair surgeries have been performed in the practice of pediatric surgeries, ensuring adequate perioperative analgesia is crucial for perioperative care as pain in pediatric patients can cause functional recuperation and lead to negative behavioral changes and family dissatisfaction. (1) Various studies are made to improve postoperative analgesia and facilitate recovery in pediatric patients.(1) Day-case surgery is defined as the planned day admission of a patient to hospital for a surgical procedure, after which there is subsequent successful and safe discharge back home on the same day in a safe and timely manner instead of spending prolonged periods within the hospital.(2) This has significant implications, including reducing hospital stay, hospital-acquired infection, and healthcare-related costs while also improving patient experience and service efficiency. Surgical, anesthetic, and patient factors should be considered for successful day case surgery.(2) External oblique intercostal plane block (EOIPB) is a novel fascial plane block which aims to provide upper midline and lateral abdominal wall analgesia thereby reducing perioperative opioid consumption , LA is deposited into the fascial plane beneath the external oblique muscle (EOM) and superficial to the sixth rib or external intercostal muscle. It targets anterior and lateral cutaneous branches of the thoracoabdominal nerves from the ventral rami of spinal nerves.(3)

Caudal block is the most frequently performed regional technique for pain management in children undergoing lower abdominal surgeries. Ultrasound guidance has resulted in enhanced reliability and safety profiles for caudal blocks.(4) The erector spinae plane block (ESPB), multiple studies demonstrated its potential as a practical approach for managing postoperative pain in the last decade, involves an ultrasound-guided injection of a relatively large volume of local anesthetic into the fascial plane beneath the erector spinae muscle. (5)

Вмешательства

  • Другое Erector Spinae Plane Block
    The correct location of the needle tip in the fascial plane deep to the erector spinae muscle will be confirmed by injecting 0.5-1 ml of saline and observing the fluid lifting the erector spinae muscle off the transverse process while avoiding muscle distension (hydro dissection)
  • Другое Caudal Block Anesthesia
    The needle will be advanced at a 20-degree angle with needle tip and length visualization. A pop can be appreciated as the needle passes through the sacrococcygeal ligament. Once the needle will be confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood.
  • Другое External Oblique Intercostal Plane Block
    the needle will be advanced until the tip lay in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs

Первичные конечные точки

  • Primary outcome [Срок оценки: 15 minute after operation , 30 minutes after operation and 4 h after operation]
Вторичные конечные точки (1)
  • Secondary outcome [Срок оценки: 6 hours]

Критерии участия

Критерии включения

  • pediatric patients of both sexes undergoing elective umblical hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.

Критерии исключения

  • Parents refusal.
  • Coagulopathy.
  • Allergy to local anesthesia.
  • Local infection at the site of injection.
  • Neurological anomalies.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Другое

Центры проведения

Египет · 1 центр
  • Mohamed Zakarea Wfa — Tanta

Идентификаторы

NCT: NCT06948253 · 36264PR1119/3/25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗