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Набор скоро начнётся NCT07113600

Erector Spinae Plane Block Versus Iliohypogastric/Ilioinguinal Nerve Block for Post-Hysterctomy Pain Relief

Без фазы С лечением Postoperative Pain, Acute

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: Nerve Block.
Кому может быть актуально
Состояния в реестре: Postoperative Pain, Acute. Базовые параметры: от 35 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Randomized Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Iliohypogastric/ Ilioinguinal Nerve Block for Postoperative Pain Relief in Female Patients Undergoing Open Hysterectomy

Обзор

The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia. One group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block). The other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ). Researchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.

Подробное описание

The use of ultrasound for the placement of peripheral nerve blocks has received a great deal of attention in anesthesiology literature as well as clinical practice. Advantages of ultrasound-guided regional anesthesia include easy learning, fast onset, higher success rates, more complete blocks, using lower local anesthetic volumes and more safety. Good postoperative analgesia can prevent morbidity associated with abdominal hysterectomy by allowing pain-free, early ambulation and decreasing the risks of long hospital stay such as thrombo-embolism, and other poor outcomes. Truncal blocks such as transversus abdominis plane (TAP) blocks have seen limited success due to shorter duration and sub-optimal analgesia. The ultrasound (US)-guided erector spinae plane block (ESPB) w gained wide attention as a fast procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, is easy to perform, and requires less training. It provides extensive, potent unilateral analgesia, is performed by local anesthetic injection in the plane between the erector spinae muscle and the Transverse process of the corresponding vertebra. The local anesthetic diffuses into the para vertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of the thoracic spinal nerves. Bilateral ESPB performed at low thoracic levels was recently shown to provide satisfactory analgesia for gynecologic and abdominal surgery.

Abdominal field blocks, such as the ilio-inguinal / ilio-hypogastric (IL-IH) nerve block are well- known as simple ways to give long-lasting pain relief and limit narcotic usage after surgery.

The ilio-inguinal and ilio-hypogastric nerves are T 12 and L 1 branches that supply the inguinal region and run between the internal oblique and transversus abdominis muscles, slightly above the anterior superior iliac spine.

The aim of this study is to compare the analgesic effect of ilio-hypogastric / ilio-inguinal versus erector spine plane block on female patients undergoing open hysterectomy.

Вмешательства

  • Другое Nerve Block
    Ilioinguinal/ Iliohypogastric nerve block: In the supine position, the ultrasound probe probe is positioned in a transverse manner, superior to the anterior superior iliac spine. The three anterior abdominal muscle layers are identified, and the two nerves are identified in the abdominal neurovascular plane. A echogenicneedle is inserted in a medial-to-lateral direction. After negative aspiration, 5 ml saline is injected to ensure correct needle tip position then 20 ml of bupivacaine 0.25% is

Первичные конечные точки

  • The time to first call for analgesia. [Срок оценки: The first 12 postoperative hours]
Вторичные конечные точки (2)
  • postoperative pain score [Срок оценки: VAS was assessed at 0, 2, 6, and 12 hours postoperatively.]
  • intraoperative hemodynamic changes [Срок оценки: Operative time]

Критерии участия

Критерии включения

  • Adult female patients above the age of 35 years.
  • American Society of Anesthesiologists (ASA) physical status I-II.

Критерии исключения

  • Patient refusal.
  • History of allergy or intolerance to study medications.
  • Chronic opioid use (>3 months).
  • Severe renal or hepatic impairment.
  • Patients with coagulopathy disorders.
  • Infection at injection sites.

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
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07113600 · N-119_2023/MSc

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗