Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy

Официальное название

Efficacy Of Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy: A Randomized Controlled Trial.

Обзор

This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries.

Подробное описание

Good perioperative analgesia in cardiac surgical patients helps early recovery, ambulation, and early discharge from the Intensive Care Unit (ICU). Traditional use of nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids associated with adverse effect commonly used for pain control postoperative.

The transversus thoracic muscle plane block (TTPB) is a recently advised regional anesthesia method that provides analgesia to the anterior chest wall and was initially introduced by Ueshima et al. in 2015 .

The pectoral nerves (PECS) block has evolved to be two different types: PECS I and PECS II. In PECS I block, anesthetic is injected in the interfacial plane between the pectoralis major and minor muscles at the 3rd rib, blocking the lateral and medial pectoral nerves. The PECS II block, which was also developed by Blanco in 2012.

The PECS block has been well established for its use in breast surgery for the adult population. , However, there has been a recent push in the last couple of years to find more about other uses for these types of blocks, especially in cardiac surgeries.

Вмешательства

• Препарат Control
  Patients will receive o.5 ug/kg/hr fentanyl infusion all through the whole operation.
• Другое Pectoral nerves (PECS)
  This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus ultrasound guided bilateral pectoral nerves (PECS) Block which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .
• Другое Transversus thoracic muscle plane block (TTPB)
  This group will receive fentanyl infusion at a dose of (0.5 μg/kg/hr) all through the whole operation, plus Ultrasound guided bilateral transversus thoracic muscle plane block (TTPB) which will be done by injecting 0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .

Первичные конечные точки

• The total dose of intraoperative fentanyl [Срок оценки: Intraoperatively]

Вторичные конечные точки (8)

• Degree of pain [Срок оценки: 12 hours postoperatively]
• Heart rate [Срок оценки: 12 hours postoperatively]
• Mean arterial pressure [Срок оценки: 12 hours postoperatively]
• Total consumption of Fentanyl [Срок оценки: 12 hours postoperatively]
• Time to 1st rescue analgesia [Срок оценки: 12 hours postoperatively]
• Time of Extubation [Срок оценки: 12 hours postoperatively]
• The incidence of opioid complications [Срок оценки: 12 hours postoperatively]
• The incidence of Local anatectic toxicity [Срок оценки: 12 hours postoperatively]

Критерии участия

Критерии включения

• Age: 6 months - 7 years.
• Gender: both sexs .
• Risk Adjustment for Congenital Heart Surgery (RACHS) II and III.
• Patients undergoing cardiac surgeries requiring cardiopulmonary bypass with midline sternotomy incision.

Критерии исключения

• Patients whose parents or legal guardians refuse to participate.
• Preoperative mechanical ventilation.
• Patients in coma, mental retardation, neurological disease, or on drugs affecting the behaviour.
• Preoperative inotropic drug infusion.
• (Bleeding disorders (drug induced i.e., coumadin; or genetic e.g. hemophilia; or acquired e.g. disseminated intravascular coagulation \[DIC\]), coagulopathy: Partial Thromboplastin Time (PTT) > 40 seconds, International Normalized Ratio (INR) > 1.4, platelet count < 100x10⁹.
• Known or suspected allergy to any of the studied drugs.
• Severe pulmonary hypertension (mean resting blood pressure in pulmonary arteries is above 70mmHg).
• Cardiopulmonary bypass time more than 90 minutes.
• local infection.
• Significant Renal impairment (creatinine more than 1.2mg/dl)
• Aortic cross-clamp time more than 45 minutes.
• Total time from induction till intensive Care Unit (ICU) transfer more than 4 hours and 30 mins.

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

Египет · 1 центр

• Cairo University — Cairo

Идентификаторы

NCT: NCT06984276 · MD-263-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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