Идёт набор NCT06322810

ESP Versus PIFB for Analgesia in Open Cardiac Surgery: a Randomized Control Trial

Без фазы С лечением Analgesia

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: Erector spinae plane block (ESPB), Pecto-intercostal fascial plane blok (PIFB).
Кому может быть актуально: Состояния в реестре: Analgesia. 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: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Comparison of Erector Spiane Plan Block (ESPB) Versus Pecto-intercostal Fascial Block(PIFB) for Analgesia and Respiratory Function Recovery in Cardiac Surgery: a Randomized Control Trial

Обзор

This clinical trial compares analgesia efficiency and recovery outcomes between two different fascial plane block techniques (ESPB vs.PIFB) in cardiac surgery patients participant population/health conditions\]. The main questions it aims to answer are: * Does ESPB provide superior analgesia than PIFB * Do patients who receive ESPB have better recovery outcomes

Подробное описание

Regional nerve blocks, including Pecto-intercostal block (PIFB) and Erector spinae plane block (ESPB), can provide a certain level of analgesia for thoracic and cardiac surgeries. This study focuses on patients undergoing their first conventional sternotomy for cardiac surgery. They are randomly assigned to receive either PIFB or ESPB for pain relief. Comparisons are made between the two groups for postoperative 48-hour analgesic medication requirements, static and dynamic postoperative pain scores, improvements in postoperative respiratory function, quality of life index (QoL15), and other clinically relevant prognostic indicators.

Вмешательства

Процедура Erector spinae plane block (ESPB)
Bilateral ESP: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side.
Процедура Pecto-intercostal fascial plane blok (PIFB)
Bilateral PIFB: 0.5% ropivacaine 0.3 ml per kg (ideal body weight) each side, 30 min before skin excision. After surgery, use pump to deliver an intermittent automatic bolus of 0.3 ml per kg 0.16% ropivacaine every 4 hours each side.

Первичные конечные точки

48hr opioid consumption [Срок оценки: Day 2]

Вторичные конечные точки (12)

Postoperative static pain scores-Day 1 [Срок оценки: Day 1]
Postoperative static pain scores-Day 2 [Срок оценки: Day 2]
Postoperative dynamic pain scores-Day 1 [Срок оценки: Day 1]
Postoperative dynamic pain scores-Day 2 [Срок оценки: Day 2]
postoperative incentive spirometry volume (ml)-Day 1 [Срок оценки: Day 1]
postoperative incentive spirometry volume (ml)-Day 2 [Срок оценки: Day 2]
postoperative incentive spirometry volume (ml)-Day 3 [Срок оценки: Day 3]
QoL15 (POD3) [Срок оценки: Day 3]
Serum cytokine (IL-6, IL-8, IL-10) - baseline [Срок оценки: During surgery (at the time the induction phase was completed, patients were under general anesthesia, and both arterial line and central venous line were in place)]
Serum cytokine (IL-6, IL-8, IL-10)- aortic declamp [Срок оценки: Within 10 min after the aortic declamping]
Serum cytokine (IL-6, IL-8, IL-10)- 6hrs after aortic decalmped [Срок оценки: 6 hours after the aorta was declamped]
Serum cytokine (IL-6, IL-8, IL-10)-24 hrs after surgery [Срок оценки: 24 hours after the surgery]

Критерии участия

Критерии включения

Adults patients, elective and first-time cardiac surgery patients undergoing traditional sternotomy. Procedures include coronary artery bypass surgery, valve repair or replacement surgery, atrial and ventricular septal defect repair surgery, and other open-heart surgeries.