Efficacy of Ultrasound Guided PIFB Versus Lidocaine Infusion on Postoperative Pain After Sternotomy

Официальное название

The Efficacy of Ultrasound-guided Pecto-Intercostal Fascial Plain Block Versus Lidocaine Infusion on Acute and Chronic Post-sternotomy Pain; A Prospective Randomized Controlled Trial

Обзор

Chronic pain is a common complication after cardiothoracic surgery. The prevalence of post-sternoyomy pain syndrome (PSPS) ranges from 33% to 91%. Exact pathogenetic mechanisms for developing chronic pain after sternotomy are unknown. Apart from intraoperative nerve damage and subsequent postoperative neuropathic pain, operation techniques, age, sex, pre-existing pain, genetic and psychosocial factors, severe postoperative pain, and analgesic management are suspected to have an impact on the development of PSPS .

Подробное описание

Ultrasound-guided Pecto-intercostal Fascial Block (PIFB) has been advocated by some researchers for cardiac surgery. Pecto-intercostal fascial plane block (PIFB) is a novel, minimally invasive, regional fascial plane block technique. PIFB was first described by de la Torre in patients undergoing breast surgery . PIFB targets the anterior intercostal nerves as they run in the fascial plane between the pectoral and the intercostal muscles and emerge on either side of the sternum.

Also, lidocaine, a short-acting local anesthetic, has been proved to have analgesic and anti-inflammatory effects . The application of lidocaine by continuous infusion in the intraoperative period and immediately after the surgery appears to reduce the immediate postoperative pain, and may prevent the PSPS

Вмешательства

• Процедура pecto intercostal fascial block using bupivacaine 0.25%
  patients will receive bilateral ultrasound-guided pecto-intercostal fascial block using 20 ml of bupivacaine 0.25% for each side.
• Препарат lidocaine infusion
  1.5 mg/kg lidocaine will be administered after induction of anesthesia, then 2mg/kg/h lidocaine will be administered with continuous intravenous infusion until the end of the surgery.

Первичные конечные точки

• Total dose of morphine in the first 24 h postoperatively. [Срок оценки: 24 hours postoperative]

Вторичные конечные точки (5)

• NRS numerical rating scale. [Срок оценки: 24 hours post operative]
• chronic postoperative pain in 3 months after operation according to numerical rating scale [Срок оценки: within 3 months postoperative]
• Time to rescue analgesic [Срок оценки: within 24 hour postoperative]
• time to extubation [Срок оценки: within 24 hour post operative]
• length of intensive care stay [Срок оценки: within one week]

Критерии участия

Критерии включения

• age between 18 and 75 years.
• patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
• American Society of Anesthesiologists classification of physical status < IV.

Критерии исключения

• emergency surgery.
• off-pump surgery.
• redo surgery.
• ejection fraction less than 35%.
• refusal of the patient.
• known hypersensitivity to LA.
• chronic opioid use or chronic pain patient.
• psychiatric problems or communication difficulties.
• liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7).
• renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
• obstructive sleep apnea syndrom.
• coexisting hematologic disorders.
• pregnancy or breastfeeding.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Benisuef University Hospital — Banī Suwayf

Идентификаторы

NCT: NCT05885230 · FMBSUREC/09042023/Mikhael

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗