Меню
Идёт набор NCT07094386

Postoperative Analgesia in Patients Undergoing Open Upper Abdominal Surgeries: External Oblique Intercostal Plane Block vs. Quadratus Lumborum Block

Без фазы С лечением Post Operative 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: External Oblique Intercostal Plain Block, Quadratus Lumborum Block, Bupivacaine %0.25 (isobaric), Bupivacaine %0.25 (isobaric).
Кому может быть актуально
Состояния в реестре: Post Operative Pain. Базовые параметры: 18 лет — 60 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Ultrasound Guided Techniques for Postoperative Analgesia in Patients Undergoing Open Upper Abdominal Surgeries: External Oblique Intercostal Plane Block vs. Quadratus Lumborum Block; A Randomized Controlled Trial

Обзор

Open upper abdominal surgeries with subcostal incisions are a cause of severe pain and can lead to pulmonary and cardiac complications, detrimental physiological effects, and may also have psychological, economic, and social adverse effects if inadequately treated. Effective pain control can avoid these complications and contribute to several clinically valuable outcomes, including earlier patient mobilization and quicker recovery, which can result in a shortened hospital stay and reduced costs. Opioids are the gold standard in postoperative pain control. however, it increases the incidence of opioid related adverse events such as respiratory depression, dizziness, nausea, vomiting and constipation. Regional analgesia plays an important role in perioperative multimodal analgesic regimens for major abdominal surgeries. The ultrasound-guided technique provides several options for relieving postoperative pain. The aim of this study is to compare the efficacy and safety of ultrasound guided external oblique intercostal plane block versus quadratus lumborum in patients undergoing open upper abdominal surgeries.

Подробное описание

Poorly controlled postoperative pain causes physiological stress, increased morbidity, delayed mobilization, prolonged hospitalization, and higher healthcare costs.

Regional anelgesia techniques have shown a promise in improving postoperative outcomes by reducing opioid consumption and related adverse effects.

This study aims to evaluate two regional blocks - EOIPB and QLB- both will be performed under ultrasound guidance.

The goal is to determine which technique offers superior analgesic efficacy, safety and overall contribution to the quality of recovery.

Вмешательства

  • Процедура External Oblique Intercostal Plain Block
    The patient will be placed in the supine position. After sterilization of the skin, a high-frequency linear probe (6-13 MHz) will be placed obliquely medial to the anterior axillary line, the 6th and 7th ribs, skin, subcutaneous tissues, and external oblique muscle \[EOM\], intercostal muscles, pleura, and the lung will be identified. An 80 mm 22-gauge block needle (Stimuplex® D, BBraun, Germany) will be inserted in-plane to the US-probe in a craniocaudal direction directed under EOM. After conf
  • Процедура Quadratus Lumborum Block
    Quadratus lumborum block will be performed. The patient will be placed in the lateral decubitus position After sterilization of the skin, a low frequency convex probe (5-8 MHz) will be positioned horizontally in the anterior axillary line half way between the subcostal margin and the iliac crest then will be advanced in the cranial direction to visualize the triple abdominal muscle layers and identifying the posterior border of the EO muscle (hook sign) with the underlying IO musclenforming a ro
  • Препарат Bupivacaine %0.25 (isobaric)
    A single injection of 30 mg of 0.25 % bupivacaine will be administered as part of the External Oblique Intercostal Plain Block under ultrasound guidance, after confirming needle placement between the external oblique and intercostal muscles.
  • Препарат Bupivacaine %0.25 (isobaric)
    A single injection of 30 mg of 0.25 % bupivacaine will be administered as part of the Quadratus Lumborum Block under ultrasound guidance, after confirming of correct needle placement and negative aspiration.

Первичные конечные точки

  • Time to first requested rescue analgesia (minutes) [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

  • Patients from both sexes.
  • 18 to 60 years old.
  • ASA physical status I- III scheduled for elective open upper abdominal surgeries, as (open nephrectomy, open cholecystectomy, liver resection, ….).
  • Patients with BMI (18.5-35) kg/ m2.

Критерии исключения

  • Patients uncooperative or refuse to sign the consent of regional block.
  • Patients with known coagulation defects. International normalized ratio (INR)> 1.5), and thrombocytopenia if platelet count < 100.000).
  • Patients with known hypersensitivity to bupivacaine, or any of the used drugs.
  • Patients with hepatic impairment, as Child-Pugh class B or C, AST/ALT > 3 times the upper limit of normal, or total bilirubin > 2 mg/dL.
  • Patients with renal impairment, chronic kidney disease stage 4 or 5 (eGFR < 30 mL/min/1.73 m²), or on regular dialysis.
  • Patients with pre-existing myopathy, defined as a clinically diagnosed muscular disorder characterized by muscle weakness, elevated creatine kinase levels, or a history of inherited or acquired muscle disease (e.g., polymyositis, muscular dystrophy).
  • Patients with pre-existing neuropathy, if clinically diagnosed as peripheral or central nerve dysfunction, including chronic sensorimotor deficits or conditions such as diabetic neuropathy, radiculopathy, or multiple sclerosis.
  • Patients with chronic pain syndromes, defined as pain persisting for more than 3 months, including fibromyalgia, complex regional pain syndrome (CRPS), or chronic pain requiring long-term opioid or neuropathic pain medications.
  • Patients with sepsis at the site of injection.
  • Patients with history of long-acting opioids or steroids preoperatively

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
Профилактика

Центры проведения

Египет · 1 центр
  • Cairo university hospitals — Cairo

Идентификаторы

NCT: NCT07094386 · MD-135-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗