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Pain Control and Recovery After Thoracic Surgery Using SPSIP Block

2 ноября 2026 г. обновлено: Ahmet Salih Tüzen, MD, Izmir Katip Celebi University

Comparison of the Analgesic Effectiveness of Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Among Different Thoracic Surgical Procedures: A Prospective Observational Cohort Study

Thoracic surgery is frequently associated with significant postoperative pain, which may impair respiratory function, mobilization, recovery, and patient satisfaction. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block that may provide effective analgesia after thoracic surgery. This prospective observational cohort study will evaluate the analgesic effectiveness and postoperative recovery associated with SPSIP block in adult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy. All patients will receive SPSIP block as part of routine institutional multimodal analgesia. The primary outcome will be postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include postoperative pain intensity, opioid consumption, rescue analgesic requirements, postoperative nausea and vomiting, pulmonary complications, patient satisfaction, length of hospital stay, and chronic postoperative pain.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Подробное описание

Postoperative pain remains an important clinical concern following thoracic surgery. Inadequate analgesia may adversely affect deep breathing, coughing, pulmonary toilet, early mobilization, and overall postoperative recovery. Although minimally invasive thoracic surgical techniques have reduced surgical trauma, clinically relevant postoperative pain may still occur. Regional anesthesia techniques are commonly incorporated into multimodal analgesic strategies for thoracic surgery. Fascial plane blocks have emerged as alternatives to more invasive regional techniques because of their relative technical simplicity and potential safety advantages. The Serratus Posterior Superior Intercostal Plane (SPSIP) block is a recently described ultrasound-guided fascial plane block with promising analgesic efficacy; however, evidence regarding whether its effectiveness differs according to the invasiveness of the thoracic surgical procedure remains limited.

This prospective observational cohort study will include adult patients undergoing elective thoracic surgery under general anesthesia who receive an ultrasound-guided SPSIP block as part of routine institutional multimodal analgesia. Patients will be categorized according to the surgical procedure into three predefined cohorts: minor video-assisted thoracoscopic surgery (VATS), major VATS, and thoracotomy. The SPSIP block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic. No participant will be assigned to a surgical procedure or regional anesthesia technique for research purposes.

The primary objective is to compare postoperative quality of recovery among the three surgical cohorts. Quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15) at 24 hours after surgery, with higher scores indicating better postoperative recovery.

Secondary outcomes will include postoperative opioid consumption expressed as morphine milligram equivalents, pain intensity measured using the Numeric Rating Scale at rest and during coughing, time to first rescue analgesia, total rescue analgesic requirement, postoperative nausea and vomiting, antiemetic requirement, hemodynamic variables, pulmonary complications, time to ambulation, length of hospital stay, and patient satisfaction. Pain intensity will be evaluated in the post-anesthesia care unit and at 2, 6, 12, and 24 hours after surgery. Patients will also be followed for clinically relevant postoperative outcomes, including hospital readmission within 30 days and chronic postoperative pain at 3 and 6 months. Potential block-related complications, including local anesthetic systemic toxicity, pneumothorax, hematoma, and infection, will be recorded.

The study is designed to determine whether postoperative recovery and analgesic outcomes associated with the same SPSIP block technique differ according to the type and invasiveness of thoracic surgery.

Тип исследования

Наблюдательный

Регистрация (Оцененный)

110

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Ahmet Salih Tüzen, M.D.
  • Номер телефона: +90 535 391 55 77
  • Электронная почта: astuzen@icloud.com

Учебное резервное копирование контактов

  • Имя: Murat Aksun, M.D.
  • Номер телефона: +90 552 363 16 14
  • Электронная почта: murataksun@yahoo.com

Места учебы

  • Турция (Туркие)
    • İzmir
      • Izmir, İzmir, Турция (Туркие), 35360
        • Рекрутинг
        • Izmir Katip Celebi University Atatürk Training and Research Hospital, Karabaglar, Izmir
        • Контакт:
          • Bilgesu Kaya Çalış, M.D.
          • Номер телефона: +90 5398795124
          • Электронная почта: bilgesukaya2@gmail.com
        • Главный следователь:
          • Murat Aksun, M.D.

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

Adults undergoing elective minor VATS, major VATS, or thoracotomy under general anesthesia who receive SPSIP block as part of routine multimodal analgesia

Описание

Inclusion Criteria:

  • Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective thoracic surgery
  • Undergoing minor video-assisted thoracoscopic surgery (VATS), major VATS, or thoracotomy
  • Planned ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine multimodal analgesia
  • Able and willing to provide written informed consent

Exclusion Criteria:

  • Patient refusal
  • Known allergy to amide local anesthetics
  • Coagulopathy
  • Therapeutic anticoagulation incompatible with regional anesthesia
  • Infection at the planned block injection site
  • Pregnancy
  • Emergency surgery
  • Chronic opioid therapy for more than 3 months
  • Chronic pain syndrome
  • Cognitive impairment that prevents reliable study assessments
  • Inability to complete the Quality of Recovery-15 (QoR-15) questionnaire

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Наблюдательные модели: COHORT
  • Временные перспективы: PROSPECTIVE

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
Minor VATS

Adult patients undergoing elective minor video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Процедура: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.
Major VATS

Adult patients undergoing elective major video-assisted thoracoscopic surgery (VATS) under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Процедура: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.
Thoracotomy

Adult patients undergoing elective thoracotomy under general anesthesia who receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block as part of routine institutional multimodal analgesia. The surgical procedure and regional analgesic technique are determined as part of routine clinical care and are not assigned by the study protocol.
Процедура: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block

An ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed after induction of general anesthesia according to routine institutional clinical practice using a long-acting local anesthetic.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Quality of Recovery-15 Score at 24 Hours
Временное ограничение: 24 hours after surgery

Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Higher scores indicate better postoperative recovery. QoR-15 scores will be compared among the minor VATS, major VATS, and thoracotomy cohorts.
24 hours after surgery

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Total Opioid Consumption During the First 24 Postoperative Hours
Временное ограничение: 0 to 24 hours after surgery

Total opioid consumption during the first 24 hours after surgery will be calculated and converted to morphine milligram equivalents (MME) to allow comparison among the three surgical cohorts.
0 to 24 hours after surgery
Pain Intensity at Rest Upon Admission to the PACU
Временное ограничение: Upon admission to the post-anesthesia care unit (PACU)

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Upon admission to the post-anesthesia care unit (PACU)
Pain Intensity at Rest at 2 Hours
Временное ограничение: 2 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
2 hours after the end of surgery
Pain Intensity at Rest at 6 Hours
Временное ограничение: 6 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
6 hours after the end of surgery
Pain Intensity at Rest at 12 Hours
Временное ограничение: 12 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
12 hours after the end of surgery
Pain Intensity at Rest at 24 Hours
Временное ограничение: 24 hours after the end of surgery

Postoperative pain intensity at rest will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
24 hours after the end of surgery
Pain Intensity During Coughing Upon Admission to the PACU
Временное ограничение: Upon admission to the post-anesthesia care unit (PACU)

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Upon admission to the post-anesthesia care unit (PACU)
Pain Intensity During Coughing at 2 Hours
Временное ограничение: 2 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
2 hours after the end of surgery
Pain Intensity During Coughing at 6 Hours
Временное ограничение: 6 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
6 hours after the end of surgery
Pain Intensity During Coughing at 12 Hours
Временное ограничение: 12 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
12 hours after the end of surgery
Pain Intensity During Coughing at 24 Hours
Временное ограничение: 24 hours after the end of surgery

Postoperative pain intensity during coughing will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
24 hours after the end of surgery
Time to First Rescue Analgesic Administration
Временное ограничение: 0 to 24 hours after surgery

Time from completion of surgery to the first administration of rescue analgesic medication will be recorded.
0 to 24 hours after surgery
Total Rescue Analgesic Requirement
Временное ограничение: 0 to 24 hours after surgery

The total amount of rescue analgesic medication administered during the postoperative observation period will be recorded.
0 to 24 hours after surgery
Incidence of Postoperative Nausea and Vomiting
Временное ограничение: 0 to 24 hours after surgery

The number of participants experiencing postoperative nausea and/or vomiting will be recorded.
0 to 24 hours after surgery
Requirement for Rescue Antiemetic Medication
Временное ограничение: 0 to 24 hours after surgery

The number of participants requiring rescue antiemetic medication will be recorded.
0 to 24 hours after surgery
Time to First Postoperative Ambulation
Временное ограничение: From the end of surgery until first postoperative ambulation or hospital discharge, whichever occurs first, assessed up to 30 days after surgery.

Time from the end of surgery to the patient's first postoperative ambulation will be recorded in hours. First ambulation will be defined as the first documented occasion on which the patient gets out of bed and ambulates with or without assistance. Patients who do not ambulate before hospital discharge will be considered not to have experienced the event during the observation period.
From the end of surgery until first postoperative ambulation or hospital discharge, whichever occurs first, assessed up to 30 days after surgery.
Postoperative Length of Hospital Stay
Временное ограничение: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.

The duration of postoperative hospitalization will be recorded in days, calculated from the end of surgery until hospital discharge.
From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Chronic Postoperative Pain at 3 Months
Временное ограничение: 3 months after surgery

Chronic postsurgical pain will be defined as pain that developed or increased in intensity after surgery, is located in the surgical area or a related innervation territory, persists at 3 months after surgery, and is not better explained by infection, malignancy, a pre-existing pain condition, or another alternative cause. Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
3 months after surgery
Chronic Postoperative Pain at 6 Months
Временное ограничение: 6 months after surgery

Chronic postsurgical pain will be defined as pain that developed or increased in intensity after surgery, is located in the surgical area or a related innervation territory, persists at 6 months after surgery, and is not better explained by infection, malignancy, a pre-existing pain condition, or another alternative cause. Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
6 months after surgery
Hospital Readmission Within 30 Days
Временное ограничение: Within 30 days after surgery

The number of participants requiring unplanned hospital readmission within 30 days after surgery will be recorded.
Within 30 days after surgery
Incidence of SPSIP Block-Related Complications
Временное ограничение: From block performance until hospital discharge, assessed up to 30 days after surgery.

The number of participants who develop one or more complications related to the Serratus Posterior Superior Intercostal Plane (SPSIP) block will be recorded. Complications will include local anesthetic systemic toxicity, pneumothorax attributable to the block, hematoma at the block site, and infection at the block site.
From block performance until hospital discharge, assessed up to 30 days after surgery.
Incidence of Postoperative Pulmonary Complications
Временное ограничение: From the end of surgery until hospital discharge, up to 30 days

Postoperative pulmonary complications will include pneumonia, clinically significant atelectasis requiring therapeutic intervention, bronchospasm requiring treatment, aspiration pneumonitis, acute respiratory distress syndrome, postoperative respiratory failure requiring non-invasive ventilatory support or reintubation, or an unplanned escalation in respiratory support. Participants experiencing at least one of these events will be considered to have a postoperative pulmonary complication.
From the end of surgery until hospital discharge, up to 30 days
Patient Satisfaction With Postoperative Analgesia
Временное ограничение: 24 hours after surgery

Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, and 5 = very satisfied. Higher scores indicate greater satisfaction with postoperative analgesia.
24 hours after surgery

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Izmir Katip Celebi University

Следователи

  • Главный следователь: Murat Aksun, M.D., Izmir Katip Celebi University Atatürk Training and Research Hospital

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 октября 2026 г.

Первичное завершение (Оцененный)

1 октября 2027 г.

Завершение исследования (Оцененный)

1 апреля 2028 г.

Даты регистрации исследования

Первый отправленный

18 сентября 2026 г.

Впервые представлено, что соответствует критериям контроля качества

24 сентября 2026 г.

Первый опубликованный (Действительный)

30 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

3 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

2 ноября 2026 г.

Последняя проверка

1 ноября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 2025-SAEK-0815

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

No individual participant data sharing is currently planned.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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