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Набор скоро начнётся NCT07582640

Comparison Between Erector Spinae Plane Block vs Transversus Abdominis Plane Block for Postoperative Analgesia in Cesarean Section

Без фазы С лечением Regional Block for Postoperative Analgesia in Cesarean Section

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 For Postoperative Analgesia In Cesarean Section, Transversus Abdominis Plane Block For Postoperative Analgesia In Cesarean Section.
Кому может быть актуально
Состояния в реестре: Regional Block for Postoperative Analgesia in Cesarean Section. Базовые параметры: 18 лет — 40 лет · Женщины.
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

Erector Spinae Plane Block Versus Transversus Abdominis Plane Block For Postoperative Analgesia In Cesarean Section: Comparative Randomized Prospective Study

Обзор

This study is a prospective randomized controlled trial designed to compare the effectiveness of the erector spinae plane (ESP) block versus the transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing cesarean section under spinal anesthesia. Sixty patients will be randomly allocated into two equal groups to receive either ESP or TAP block after surgery. The primary outcome of the study is the assessment of postoperative pain using the Numeric Rating Scale (NRS) over the first 24 hours. Secondary outcomes include total morphine consumption, time to first request for rescue analgesia, patient satisfaction, incidence of complications, and hemodynamic stability. All patients will receive standardized spinal anesthesia followed by the assigned block using a combination of bupivacaine and lidocaine under ultrasound guidance. Postoperatively, a multimodal analgesic regimen will be applied, including regular paracetamol and rescue analgesia with ketorolac or morphine based on pain scores. The rationale of the study is based on the limitation of the TAP block in providing only somatic analgesia, whereas the ESP block may offer both somatic and visceral pain control due to its wider spread. Therefore, the study aims to determine whether ESP block provides superior postoperative analgesia and reduces opioid requirements compared to TAP block after cesarean delivery.

Вмешательства

  • Процедура Erector Spinae Plane Block For Postoperative Analgesia In Cesarean Section
    For the ESP block, patients will be placed in the right lateral decubitus position, and the T9 transverse process will be identified using a high-frequency linear ultrasound probe positioned 2-3 cm lateral to the midline in a parasagittal orientation. After skin sterilization, a 21-gauge echogenic block needle will be advanced in-plane cranio-caudally until contact with the transverse process is achieved. Hydrodissection with sterile saline will be performed to confirm correct fascial plane plac
  • Процедура Transversus Abdominis Plane Block For Postoperative Analgesia In Cesarean Section
    For the TAP block, patients will be placed supine, and the posterior approach will be used with the probe placed midway between the subcostal margin and the iliac crest in the anterior axillary line. The fascial plane between the internal oblique and transversus abdominis muscles will be visualized until it tapers toward the quadratus lumborum. A 21-gauge echogenic needle will be introduced in-plane from anterior to posterior, and hydrodissection with sterile saline will be performed to confirm

Первичные конечные точки

  • Postoperative pain scores assessment using the Numeric Rating Scale (NRS). [Срок оценки: Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.]
Вторичные конечные точки (4)
  • Total morphine consumption [Срок оценки: the first 24 hours postoperatively.]
  • Time to first request for rescue analgesia. [Срок оценки: during the first 24 postoperative hours.]
  • Patient satisfaction scores [Срок оценки: at 24 hours.]
  • Incidence of block-related complications [Срок оценки: first 24 hours postoperatively.]

Критерии участия

Критерии включения

  • Age from 18 to 40 years old.
  • Pregnant women.
  • Scheduled for lower-segment cesarean section.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Singleton pregnancy at ≥37 weeks' gestation.

Критерии исключения

  • • Contraindications to regional blocks or local anesthetics.
  • History of chronic analgesic use or opioid dependency.
  • Coagulopathy or anticoagulant therapy.
  • Local infection at the injection site.
  • Allergy to study medications.
  • Patient refusal.

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
Простое слепое
Основная цель
Другое

Центры проведения

Египет · 1 центр
  • Sohag Faculty of Medicine — Sohag

Идентификаторы

NCT: NCT07582640 · soh-Med-26-3-10MS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗