Analgesic Effectiveness of SPSIPB Versus Thoracic Epidural and Systemic Opioid Analgesia After VATS (SPSIPB-VATS)

Официальное название

Prospective Evaluation of Analgesic Outcomes of Serratus Posterior Superior Intercostal Plane Block Versus Thoracic Epidural Analgesia and Systemic Opioid Analgesia After Video-Assisted Thoracoscopic Surgery

Обзор

This prospective observational study aims to compare the postoperative analgesic effectiveness of three commonly used pain management strategies in video-assisted thoracoscopic surgery (VATS): Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Thoracic Epidural Analgesia (TEA), and systemic opioid analgesia. The study evaluates postoperative pain scores, opioid consumption, and the need for rescue analgesics within the first 24 hours after surgery. By analyzing analgesic performance and safety profiles of these techniques, the study seeks to provide evidence to guide optimal postoperative pain management for patients undergoing minimally invasive thoracic procedures.

Подробное описание

This prospective observational clinical study investigates the comparative analgesic performance of three postoperative pain management strategies in patients undergoing video-assisted thoracoscopic surgery (VATS): Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Thoracic Epidural Analgesia (TEA), and systemic opioid analgesia. SPSIPB is a recently defined interfascial plane block that may provide multi-dermatomal analgesia of the upper thoracic region with a less invasive profile compared with traditional neuraxial techniques. TEA, although considered effective for thoracic surgery, is associated with technical difficulty and potential adverse effects such as hypotension, urinary retention, and motor block. Systemic opioid analgesia remains widely used but may be limited by nausea, sedation, and opioid-related complications.

In this study, adult patients scheduled for elective VATS under general anesthesia will be managed with one of the three analgesic strategies as part of routine clinical practice. No randomization or allocation will be performed by the investigators; analgesic technique selection will follow standard clinical decision-making by the treating anesthesiologist. Postoperative pain will be evaluated using the Numerical Rating Scale (NRS) at predefined time points, including 0, 1, 2, 6, 12, and 24 hours after surgery. Total opioid consumption within the first 24 hours will be quantified as the primary outcome, expressed in tramadol-equivalent dosing. Secondary outcomes include the requirement for rescue analgesics, postoperative nausea and vomiting, hemodynamic parameters, and the Quality of Recovery-15 (QoR-15) score.

The study aims to provide comparative clinical evidence on the analgesic efficacy and tolerability of SPSIPB relative to TEA and systemic opioid analgesia in minimally invasive thoracic surgery. By identifying potential advantages or limitations of each technique, the findings may support optimization of multimodal analgesia protocols, improve postoperative comfort, and contribute to enhanced recovery strategies in VATS patients.

Первичные конечные точки

• Opioid Consumption [Срок оценки: 24 hours postoperatively]

Вторичные конечные точки (8)

• Pain Scores [Срок оценки: 0, 1, 2, 6, 12, and 24 hours after surgery]
• Need for Rescue Analgesia [Срок оценки: First 24 hours postoperatively]
• Incidence of Postoperative Nausea and Vomiting (PONV) [Срок оценки: First 24 hours postoperatively]
• Heart Rate (beats per minute) [Срок оценки: Intraoperative and first 24 hours postoperative]
• Quality of Recovery Score (QoR-15) [Срок оценки: Preoperative baseline and 24 hours postoperative]
• Time to First Opioid Request [Срок оценки: First 24 hours postoperatively]
• Mean Arterial Pressure (mmHg) [Срок оценки: Intraoperative and first 24 hours postoperative]
• Peripheral Oxygen Saturation (SpO₂,%) [Срок оценки: Intraoperative and first 24 hours postoperative]

Критерии участия

Критерии включения

• Adults aged 18-75 years
• Scheduled for elective video-assisted thoracoscopic surgery (VATS)
• ASA physical status I-III
• Ability to understand study procedures and provide written informed consent
• Hemodynamically stable preoperatively

Критерии исключения

• Known allergy or contraindication to local anesthetics or study medications
• Coagulopathy or use of anticoagulants not suitable for regional anesthesia
• Local infection or skin lesions at the injection site
• Severe pulmonary disease (e.g., severe COPD, uncontrolled asthma)
• Chronic opioid use or chronic pain disorders
• Neurological or psychiatric disorders impairing cooperation
• Pregnancy or breastfeeding
• BMI > 35 kg/m²
• Conversion from VATS to thoracotomy
• Inability to comply with postoperative assessments

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Bilal B, Ciftci B, Alver S, Ahiskalioglu A, Tulgar S. Serratus posterior superior intercostal plane block: novel block for minimal invasive cardiac surgery -A report of three cases. Korean J Anesthesiol. 2024 Feb;77(1):166-168. doi: 10.4097/kja.23542. Epub 2023 Oct 18. No abstract available. PMID 37852626
• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb. PMID 36883093
• Koksal BG, Baytar C, Bayraktar E, Balbaloglu H. Effects of serratus posterior superior intercostal plane block on postoperative analgesia in patients undergoing breast cancer surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 24;25(1):209. doi: 10.1186/s12871-025-03092-0. PMID 40275145

Идентификаторы

NCT: NCT07238348 · 2024/176 · 2024/276

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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