Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07238348

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Opioid Consumption

    Time frame: 24 hours postoperatively

    Total Opioid Consumption at 24 Hours

Secondary outcomes

  1. Pain Scores

    Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery

    Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS), which ranges from 0 to 10, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.

  2. Need for Rescue Analgesia

    Time frame: First 24 hours postoperatively

    Number of patients requiring additional analgesics despite standard postoperative analgesia.

  3. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: First 24 hours postoperatively

    "PONV will be assessed using the Postoperative Nausea and Vomiting Intensity Scale (PONV Intensity Scale), which ranges from 0 to 3, where:

    0 = No nausea or vomiting

    • = Mild nausea
    • = Moderate nausea or single episode of vomiting
    • = Severe nausea or two or more vomiting episodes

    Higher scores indicate more severe PONV. The presence of any nausea or vomiting and its severity will be recorded."

  4. Heart Rate (beats per minute)

    Time frame: Intraoperative and first 24 hours postoperative

    "Heart rate will be recorded intraoperatively and during the first 24 postoperative hours. Heart rate is measured in beats per minute (bpm). Higher values indicate increased sympathetic activity or hemodynamic stress."

  5. Quality of Recovery Score (QoR-15)

    Time frame: Preoperative baseline and 24 hours postoperative

    "The quality of postoperative recovery will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire.

    The QoR-15 is a validated patient-reported outcome measure with a score range from 0 to 150.

    0 = poorest possible recovery

    150 = best possible recovery

    Higher scores indicate better postoperative recovery. Scores will be recorded preoperatively (baseline) and at 24 hours postoperatively."

  6. Time to First Opioid Request

    Time frame: First 24 hours postoperatively

    Time elapsed between arrival in the postoperative care unit and the first analgesic request via PCA.

  7. Mean Arterial Pressure (mmHg)

    Time frame: Intraoperative and first 24 hours postoperative

    "Mean arterial pressure will be measured intraoperatively and during the first 24 postoperative hours. Mean arterial pressure is expressed in millimeters of mercury (mmHg). Higher or lower deviations from baseline may indicate hemodynamic instability."

  8. Peripheral Oxygen Saturation (SpO₂,%)

    Time frame: Intraoperative and first 24 hours postoperative

    "Peripheral oxygen saturation (SpO₂) will be monitored intraoperatively and during the first 24 postoperative hours. SpO₂ is reported as a percentage (%), ranging from 0% to 100%, where higher values indicate better oxygenation."

Study contacts

Contact information is provided by the study sponsor or research team.

Ali AKDOGAN, MD

CONTACT

[email protected]

+905322605414

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Acronym: SPSIPB-VATS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.