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Набор скоро начнётся NCT06778642

Postoperative Analgesic Comparison of SPSI Block and SAP Block in Video-Assisted Thoracoscopic Surgery (VATS)

Без фазы С лечением Acute 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: Serratus Posterior Superior Intercostal Plane Block, Serratus Anterior Plane Block.
Кому может быть актуально
Состояния в реестре: Acute Post Operative Pain. Базовые параметры: 18 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Comparison of the Postoperative Analgesic Effectiveness of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Video-Assisted Thoracoscopic Surgery (VATS)

Обзор

In our study, we primarily aimed to compare the postoperative analgesic effectiveness of the Serratus Posterior Superior Intercostal Plane Block and the Serratus Anterior Plane Block, both routinely applied in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS)

Подробное описание

In Video-Assisted Thoracoscopic Surgery (VATS), the thoracic cavity is visualized through a small incision in the chest wall. VATS allows for procedures such as lobectomy, bullectomy, and wedge resection. Compared to thoracotomy, VATS offers lower costs, better pulmonary function, less pain, and earlier postoperative mobilization. The success of postoperative rehabilitation in thoracic surgery patients can be improved with minimally invasive procedures and effective pain control.

The multimodal analgesic approach, which involves the combined use of analgesic drugs with different mechanisms (NSAIDs, paracetamol, opioids, etc.) along with regional/local techniques, aims to achieve additive and synergistic effects. This approach reduces the need for high doses of a single analgesic, minimizes side effects, and provides more effective pain control.

Investigators routinely apply opioids, NSAIDs, paracetamol, intravenous patient-controlled analgesia (PCA) devices, and regional techniques such as thoracic paravertebral block, serratus anterior plane block (SAPB), serratus posterior superior intercostal plane block (SPSIPB), and erector spinae plane (ESP) block for postoperative pain management in VATS patients.

The primary objective of this study is to compare the effects of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Serratus Anterior Plane Block (SAPB), both routinely used in thoracic anesthesia practice, on postoperative pain scores and analgesic needs in VATS patients.

The SAPB, which is an essential component of multimodal analgesia in thoracic surgery, offers safe and precise analgesic effects with low complication rates. The block covers most VATS incisions and chest tube sites, providing better postoperative analgesia and potentially improving lung function. Similarly, SPSIPB, another thoracic wall fascial plane block, has been shown to be effective in managing both acute and chronic pain. It is reported to provide good analgesia in the thoracic region after VATS.

The study will include patients aged 18-80 years scheduled for VATS at Uludağ University Medical Faculty Hospital. Patients with ASA I, II, and III classifications will be included.

Patients will be randomized into two groups:

Group 1: SPSIPB (n=45) Group 2: SAPB (n=45) Both blocks will be applied after standard anesthesia induction, intubation, surgical positioning, and before surgical incision.

During the intraoperative period, if heart rate or mean arterial pressure (MAP) increases by more than 20% from baseline measurements, IV fentanyl (1 µg/kg) will be administered as needed. Prior to the surgical incision, all patients will receive IV paracetamol (10 mg/kg), tenoxicam (20 mg), and metoclopramide (10 mg) as part of routine practice.

Fifteen minutes before awakening, a patient-controlled analgesia (PCA) device will be connected to each patient. The PCA device will be prepared with 1 mg/ml morphine solution, with a bolus dose of 2 ml and a lockout interval of 15 minutes. In patients with an NRS score of ≥4, IV tramadol (100 mg/2 ml) will be administered as a rescue analgesic. The pain score at the time of rescue analgesia, the time of the first PCA request, and the NRS score at that time will be recorded.

Вмешательства

  • Процедура Serratus Posterior Superior Intercostal Plane Block
    Patients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with bupivacaine after induction and before the surgical procedure begins.
  • Процедура Serratus Anterior Plane Block
    Patients undergoing Video-Assisted Thoracoscopic Surgery (VATS) will receive either a Serratus Anterior Plane Block (SAPB) with bupivacaine after induction and before the surgical procedure begins.

Первичные конечные точки

  • The Numerical Rating Scale (NRS) [Срок оценки: 2 days]

Критерии участия

Критерии включения

  • Patients aged 18 to 80 years undergoing Video-Assisted Thoracoscopic Surgery (VATS)
  • Scheduled at Uludağ University Faculty of Medicine Hospital Operating Room
  • Classified as ASA I, II, or III according to the American Society of Anesthesiologists (ASA) criteria

Критерии исключения

  • Allergy to local anesthetics or contraindications to bupivacaine
  • Known or suspected coagulopathy
  • Infection at the injection site
  • History of thoracic surgery
  • Severe neurological or psychiatric disorders
  • Severe cardiovascular disease
  • Liver failure
  • Renal failure (glomerular filtration rate < 15 ml/min/1.73 m²)
  • Chronic opioid use

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06778642 · UU-AN-RBC-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗