Rhomboid Intercostal Sub-serratus Plane Block Versus External Oblique Intercostal Block in Open Nephrectomy

Официальное название

Ultrasound Guided Rhomboid Intercostal Sub-serratus Plane Block Versus External Oblique Intercostal Block in Open Nephrectomy: Randomized Controlled Study

Обзор

This study aims to compare time of first request of analgesia among patients undergoing rhomboid intercostal sub-serratus plane block versus external oblique intercostal block for perioperative pain management in open nephrectomy.

Подробное описание

Open nephrectomy is a common surgery usually performed for malignant and non-malignant renal pathologies. Open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery.

The rhomboid intercostal block has previously been used for pain management in thoracic wall surgery.

Subserratus plane block in the treatment of post-abdominal surgical pain and the combination of the two blocks was subsequently renamed the "RISS block". The nerves targeted by the RISS block include the lateral cutaneous branches of the ventral branches of the thoracic intercostal nerves, located between the rhomboid muscle and the intercostal muscles, and deep into the scapula serratus anterior muscle. RISS block provides analgesia from T4 to T9 thoracic dermatomes and has been used in postoperative pain management for thoracic surgeries and upper abdominal surgeries.

Вмешательства

• Другое Rhomboid intercostal subserratus plane block
  Patients will receive the rhomboid intercostal subserratus plane block.
• Другое External oblique intercostal block
  Patients will receive the external oblique intercostal block.
• Препарат Intravenous morphine
  Patients will not receive any interventions (Intravenous morphine 0.1mg/kg after induction of general anesthesia).

Первичные конечные точки

• Time of first request of analgesia [Срок оценки: 24 hours postoperatively]

Вторичные конечные точки (6)

• Heart rate [Срок оценки: 24 hours postoperatively]
• Mean arterial blood pressure [Срок оценки: 24 hours postoperatively]
• Total amount of fentanyl [Срок оценки: 24 hours postoperatively]
• Total morphine consumption [Срок оценки: 24 hours postoperatively]
• Degree of pain [Срок оценки: 24 hours postoperatively]
• Incidence of block related complications [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

• Both sexes.
• American Society of Anesthesiologists (ASA) physical status II, III.
• Body mass index (BMI): > 20 kg/ m2 and < 35 kg/ m2.
• Patients undergoing open nephrectomy.

Критерии исключения

• Patient refusal.
• BMI <20 kg/m2 and >35 kg/m2
• Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
• History of psychiatric and cognitive disorders or chronic pain.
• Contraindication to regional anesthesia e.g pre- existing peripheral neuropathies.
• Severe respiratory or cardiac disorders.
• Advanced liver or kidney disease.
• Pregnancy.
• Physical status ASA IV.
• Coagulopathy with INR ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities \& deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency \& therapeutic anticoagulants drugs).

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

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Cairo

Идентификаторы

NCT: NCT07642193 · AP2604-501-160-209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗