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

Karadeniz Technical University

Status: Not yet enrolling

Conditions: Thoracic Epidural Analgesia; Postoperative Pain Management; Video-assisted Thoracoscopic Surgery (VATS); Serratus Posterior Superior Intercostal Plane Block

Study type: Observational

Funder types: Other

Identifiers

NCT07238348

2024/176

2024/276 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

120 participants in 3 patient groups

SPSIPB Group

Description:

Patients receiving Serratus Posterior Superior Intercostal Plane Block (SPSIPB) as part of routine postoperative analgesia for VATS.

Thoracic Epidural Analgesia (TEA) Group

Description:

Patients receiving thoracic epidural analgesia with continuous epidural infusion for postoperative pain control following VATS.

Systemic Opioid Analgesia Group

Description:

Patients managed with intravenous systemic opioid analgesia (e.g., tramadol PCA) as standard postoperative analgesia after VATS.