- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07467291
Блок SPSIP против блока SAP для боли после VATS
Сравнение блокады межреберной плоскости верхней задней зубчатой мышцы и блокады плоскости передней зубчатой мышцы для обезболивания после видеоассистированной торакоскопической операции
Comparison of Superior Serratus Posterior Intercostal Plane Block and Serratus Anterior Plane Block for Pain Management Following Video-Assisted Thoracoscopic Surgery: A Prospective Observational Cohort Study
Introduction Video-assisted thoracoscopic surgery (VATS) is associated with lower postoperative pain, shorter hospital stays, and better preservation of pulmonary function compared with conventional thoracotomy, owing to its minimally invasive nature. Although VATS was initially performed using a multi-port technique, it has evolved into a single-port approach, reflecting advances in surgical techniques and equipment. In Uniportal VATS, limiting surgical trauma to a single intercostal space may reduce the risk of chronic postoperative pain by decreasing intercostal nerve damage.
Because inadequate pain control after VATS may predispose patients to developing chronic post-thoracotomy pain syndrome (PTPS), effective postoperative analgesia is critically important. Therefore, regional analgesic techniques are recommended as part of multimodal analgesia. PROSPECT guidelines do not recommend the routine use of thoracic epidural analgesia for VATS, despite its effectiveness, because of its invasiveness; instead, they emphasize peripheral blocks such as paravertebral block and erector spinae plane block.
Although not included among first-line analgesic interventions in PROSPECT guidelines, the serratus anterior plane block (SAPB) is a widely used and well-established technique in thoracic surgery. In addition, the superior serratus posterior intercostal plane block (SPSIPB) is gaining attention in VATS surgery because of its analgesic effect covering the C3-T10 dermatomes.
Although there are studies in the literature comparing SAPB with different regional techniques, direct comparisons with SPSIPB are limited. Therefore, this prospective observational cohort study aimed to compare postoperative analgesic outcomes in patients undergoing uniportal VATS who received either ultrasound-guided SPSIPB or SAPB, with the block type selected by the attending anesthesiologist as part of routine clinical care.
Обзор исследования
Статус
Подробное описание
This single-center prospective observational cohort study included adult patients undergoing elective uniportal VATS who received an ultrasound-guided serratus anterior plane block (SAPB) or serratus posterior superior intercostal plane block (SPSIPB) for postoperative analgesia. Patients were not randomized; the block type was selected by the attending anesthesiologist as part of routine clinical care. All blocks were performed with 30 mL of 0.25% bupivacaine at the end of surgery. Postoperative pain scores and rescue analgesic use were recorded in routine observation forms by recovery unit and ward nurses who were not informed of the block type. Postoperative analgesia followed a standard multimodal protocol, with 50 mg intravenous tramadol given as rescue analgesia when the resting NRS score was 4 or higher.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Elâzığ, Турция (Туркие), 23100
- Fırat University Faculty of Medicine Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Adult patients undergoing elective uniportal video-assisted thoracoscopic surgery at Firat University Hospital who received either a serratus anterior plane block or a serratus posterior superior intercostal plane block for postoperative analgesia as part of routine care.
Описание
Inclusion Criteria:
- aged 18-65 years,
- with American Society of Anesthesiologists (ASA) physical status classification I-III,
- Body Mass Index (BMI) < 35 kg/m²,
- and who read and signed the informed consent form were included.
Exclusion Criteria:
- inability to communicate in Turkish, refusal to consent,
- inability to use the numerical pain rating scale (NRS),
- allergy to local anesthetics or study-specific analgesics;
- pregnancy or breastfeeding;
- uncontrolled anxiety or substance dependence;
- history of thoracic surgery,
- trauma,
- neuromuscular or peripheral nerve disorders;
- diabetes mellitus,
- hepatic or renal insufficiency,
- coagulation disorders;
- chronic opioid or steroid use;
- widespread pain;
- anticoagulant therapy;
- infection at the block application site;
- early termination of surgery;
- absence of planned postoperative extubation.
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: COHORT
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Serratus posterior superior intercostal plane block Group
Patients who received an ultrasound-guided serratus posterior superior intercostal plane block (30 mL of 0.25% bupivacaine) at the end of uniportal VATS for postoperative analgesia. The block type was selected by the attending anesthesiologist as part of routine clinical care; patients were not randomized. |
The procedure was performed with the patient in the lateral decubitus position. After a slight lateral displacement of the scapula, the scapular spine was visualized with ultrasound, and the probe was moved medially. After locating the tip of the scapular spine, the probe was placed sagittally at the superior angle of the scapula, and the third rib was visualized. The block needle was advanced craniocaudally and placed between the posterior superior serratus muscle and the third rib. Hydrodissection was performed with an injection of 2 mL of saline to confirm block needle placement. After confirming the block site, 30 mL of 0.25% bupivacaine was injected. |
|
Serratus Anterior Plane Block (SAPB) group
Patients who received an ultrasound-guided serratus anterior plane block (30 mL of 0.25% bupivacaine) at the end of uniportal VATS for postoperative analgesia. The block type was selected by the attending anesthesiologist as part of routine clinical care; patients were not randomized. |
The block was performed with the patient in the lateral decubitus position. Ultrasound-guided SAPB was performed by the same anesthesiologist with over three years of experience in ultrasound-guided regional anesthesia, using a high-frequency linear probe (LOGIQ e Ultrasound, GE HealthCare, United States). The probe was positioned parallel to the mid-axillary line, and the ribs were readily identified as hyperechogenic lines. The fifth rib was identified in the mid-axillary line. Using an in-plane technique, the needle was placed in the myofascial plane between the serratus anterior muscle and the fifth rib, and 30 mL of 0.25% bupivacaine was injected. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
To determine the effectiveness of ultrasound-guided SPSIP block versus SAP block after VATS using postoperative NRS pain scores.
Временное ограничение: NRS scores will be assessed upon admission to the post-anesthesia care unit (0 min), at 30 minutes, and at 1, 6, 12, 18, and 24 hours postoperatively.
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The NRS score is based on the patient rating their pain on a scale from 0 to 10. Zero indicates no pain, while 10 indicates the most severe pain possible. |
NRS scores will be assessed upon admission to the post-anesthesia care unit (0 min), at 30 minutes, and at 1, 6, 12, 18, and 24 hours postoperatively.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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QoR-15 recovery score
Временное ограничение: up to 48 hours
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The QoR-15 (Quality of Recovery-15) scale is a patient-reported outcome questionnaire used to evaluate the quality of postoperative recovery. The QoR-15 consists of 15 items assessing five domains: pain, physical comfort, physical independence, psychological support, and emotional state. The total score ranges from 0 to 150, with higher scores indicating a better quality of recovery. |
up to 48 hours
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Time to first rescue analgesia
Временное ограничение: up to 24 hours
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The time to first rescue analgesia, defined as the time interval between recovery from anesthesia and the first administration of rescue analgesia (50 mg intravenous tramadol for NRS ≥4), was recorded and expressed in hours. |
up to 24 hours
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The total amount of rescue analgesic consumption
Временное ограничение: up to 24 hours
|
The total amount of rescue analgesic consumption within the first 24 postoperative hours (mg) was also documented. |
up to 24 hours
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The incidence of block-related complications.
Временное ограничение: up to 48 hours
|
block-related complications such as hematoma, paralysis, hypotension or other adverse events were recorded. |
up to 48 hours
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Ahmet Aksu, MD, Firat University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Боль
- Неврологические проявления
- Послеоперационные осложнения
- Патологические процессы
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Боль, Послеоперационный
- Ферменты и коэнзименты
- Характеристики населения
- Демография
- Коэнзименты
- Сфинголипидные Активаторные Белки
- Группы населения
- Сапозины
Другие идентификационные номера исследования
- 43757
Планирование данных отдельных участников (IPD)
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