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Набор скоро начнётся NCT07582029

Ultrasound-Guided Rectus Sheath Block Versus Local Infiltration

Без фазы С лечением Cholelithiases Cholecystitis Postoperative Pain

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: Rectus Sheath Block, Local Anesthetic Infiltration.
Кому может быть актуально
Состояния в реестре: Cholelithiases, Cholecystitis, Postoperative Pain. Базовые параметры: от 18 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 Local Anesthetic Infiltration and Ultrasound-Guided Rectus Sheath Block in Laparoscopic Cholecystectomy Operations: A Prospective Randomized Controlled Study

Обзор

Laparoscopic cholecystectomy is associated with significant postoperative pain originating from trocar sites, pneumoperitoneum, and visceral irritation. Both local anesthetic infiltration and ultrasound-guided rectus sheath block are commonly used regional analgesic techniques to reduce postoperative pain and opioid consumption. This prospective randomized controlled study aims to compare the effects of these two techniques on postoperative pain scores, opioid requirements, and analgesia-related adverse effects following laparoscopic cholecystectomy.

Подробное описание

Laparoscopic cholecystectomy is a very commonly performed and painful surgical procedure. The etiology of pain is complex and commonly includes pain related to trocar insertion sites, pain secondary to carbon dioxide insufflation, visceral pain, and shoulder pain. Various analgesic medications and regional anesthesia techniques are used for postoperative pain management. Abdominal wall blocks are frequently utilized to reduce opioid-related adverse effects.

Rectus sheath block is a regional anesthesia technique that blocks the anterior cutaneous branches of the lower thoracic nerves (T7-T12) and is used for analgesia in laparoscopic surgeries. Several studies have demonstrated that local anesthetic infiltration provides effective analgesia in laparoscopic cholecystectomy. Although rectus sheath block is an old technique traditionally used in midline surgeries, its analgesic use in laparoscopic procedures has increased in recent years.

In this prospective randomized clinical trial, we aimed to compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.

To compare the effects of Local Anesthetic Infiltration and Rectus Sheath Block on opioid consumption and pain scores in laparoscopic gallbladder surgery.

Вмешательства

  • Процедура Rectus Sheath Block
    After completion of the operation, during the surgical closure phase, bilateral rectus sheath block will be performed. A linear ultrasound probe will be placed transversely over the umbilicus and 1 cm lateral to it. After visualization of the rectus abdominis muscle and posterior rectus sheath, a 22-Gauge 80 mm block needle (Braun Stimuplex Ultra-360, Melsungen, Germany) will be advanced from lateral to medial using the in-plane technique. Following hydrodissection with 1 mL saline between the r
  • Процедура Local Anesthetic Infiltration
    At the end of the operation, the surgeon will infiltrate 5 mL local anesthetic (0.5% bupivacaine) subcutaneously into each of the four trocar insertion sites.

Первичные конечные точки

  • NRS Score [Срок оценки: Pain scores will be assessed and recorded at postoperative 0, 1, 4, 12, and 24 hours.]
Вторичные конечные точки (2)
  • Opioid Consumption [Срок оценки: 24 hour]
  • Adverse Effects [Срок оценки: 24 hour]

Критерии участия

Критерии включения

  • ASA (American Society of Anesthesiologists) class I-II patients
  • Patients aged between 18 and 65 years
  • Patients undergoing laparoscopic cholecystectomy surgery

Критерии исключения

  • ASA class III-IV patients
  • Patients undergoing emergency surgery
  • Relatives of patients who do not provide consent
  • Presence of chronic pain
  • Chronic opioid use
  • Presence of local anesthetic allergy
  • Ibuprofen allergy
  • Paracetamol allergy
  • Presence of infection at the block site
  • Coagulopathy
  • Increased intracranial pressure
  • Pre-existing neurological deficit
  • Severe organ failure
  • Mental retardation
  • Anatomical deformity

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
Лечение

Центры проведения

Turkey (Türkiye) · 1 центр
  • Sisli Hamidiye Etfal Training Hospital — Istanbul

Идентификаторы

NCT: NCT07582029 · zeynep-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗