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

November 18, 2025 updated by: Ali AKDOĞAN, Karadeniz Technical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (18-75 years) undergoing elective video-assisted thoracoscopic surgery (VATS) under general anesthesia at a tertiary university hospital. Patients will receive SPSIPB, thoracic epidural analgesia, or systemic opioid analgesia as part of routine clinical practice, and will be followed for postoperative pain outcomes within the first 24 hours.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
SPSIPB Group
Patients receiving Serratus Posterior Superior Intercostal Plane Block (SPSIPB) as part of routine postoperative analgesia for VATS.
Thoracic Epidural Analgesia (TEA) Group
Patients receiving thoracic epidural analgesia with continuous epidural infusion for postoperative pain control following VATS.
Systemic Opioid Analgesia Group
Patients managed with intravenous systemic opioid analgesia (e.g., tramadol PCA) as standard postoperative analgesia after VATS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: 24 hours postoperatively
Total Opioid Consumption at 24 Hours
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 1, 2, 6, 12, and 24 hours after surgery
Need for Rescue Analgesia
Time Frame: First 24 hours postoperatively
Number of patients requiring additional analgesics despite standard postoperative analgesia.
First 24 hours postoperatively
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

  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."
First 24 hours postoperatively
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."
Intraoperative and first 24 hours postoperative
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."
Preoperative baseline and 24 hours postoperative
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.
First 24 hours postoperatively
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."
Intraoperative and first 24 hours postoperative
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."
Intraoperative and first 24 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karadeniz Technical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

August 15, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/176
  • 2024/276 (Other Identifier: Karadeiz Technical University, Local ethics Comitee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the study does not include a data-sharing plan and contains identifiable clinical information that cannot be released.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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