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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07238348
Acronym
SPSIPB-VATS
Enrollment
120
Registered
2025-11-20
Start date
2025-12-15
Completion date
2026-08-15
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Serratus Posterior Superior Intercostal Plane Block, Thoracic Epidural Analgesia, Systemic Opioid Analgesia, Video-Assisted Thoracoscopic Surgery, Opioid Consumption, Pain Management

Brief summary

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.

Detailed 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.

Interventions

None listed

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Opioid Consumption24 hours postoperativelyTotal Opioid Consumption at 24 Hours

Secondary

MeasureTime frameDescription
Need for Rescue AnalgesiaFirst 24 hours postoperativelyNumber of patients requiring additional analgesics despite standard postoperative analgesia.
Incidence of Postoperative Nausea and Vomiting (PONV)First 24 hours postoperativelyPONV 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 1. = Mild nausea 2. = Moderate nausea or single episode of vomiting 3. = 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.
Heart Rate (beats per minute)Intraoperative and first 24 hours postoperativeHeart 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.
Pain Scores0, 1, 2, 6, 12, and 24 hours after surgeryPostoperative 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.
Time to First Opioid RequestFirst 24 hours postoperativelyTime elapsed between arrival in the postoperative care unit and the first analgesic request via PCA.
Mean Arterial Pressure (mmHg)Intraoperative and first 24 hours postoperativeMean 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.
Peripheral Oxygen Saturation (SpO₂,%)Intraoperative and first 24 hours postoperativePeripheral 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.
Quality of Recovery Score (QoR-15)Preoperative baseline and 24 hours postoperativeThe 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.

Contacts

Primary ContactAli AKDOGAN, MD
draliakdogan@yahoo.com+905322605414

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026