Postoperative Pain ManagementSPSIPB-VATSNCT07238348
Analgesic Effectiveness of SPSIPB Versus Thoracic Epidural and Systemic Opioid Analgesia After VATS (SPSIPB-VATS)
An observational study of Postoperative Pain Management and Video-assisted Thoracoscopic Surgery (VATS), run by Karadeniz Technical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain Management, Video-assisted Thoracoscopic Surgery (VATS), Thoracic Epidural Analgesia
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy or breastfeeding
- BMI > 35 kg/m²
- Conversion from VATS to thoracotomy
- Inability to comply with postoperative assessments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Postoperative Pain Management, Video-assisted Thoracoscopic Surgery (VATS), Thoracic Epidural Analgesia, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Serratus Posterior Superior Intercostal Plane Block, Thoracic Epidural Analgesia, Systemic Opioid Analgesia, Video-Assisted Thoracoscopic Surgery, Opioid Consumption, Pain Management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Total Opioid Consumption at 24 Hours
Measured: 24 hours postoperatively
Secondary outcomes (8)
Pain Scores
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.
Measured: 0, 1, 2, 6, 12, and 24 hours after surgery
Need for Rescue Analgesia
Number of patients requiring additional analgesics despite standard postoperative analgesia.
Measured: First 24 hours postoperatively
Incidence of Postoperative Nausea and Vomiting (PONV)
"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."
Measured: First 24 hours postoperatively
Heart Rate (beats per minute)
"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."
Measured: Intraoperative and first 24 hours postoperative
Quality of Recovery Score (QoR-15)
"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."
Measured: Preoperative baseline and 24 hours postoperative
Time to First Opioid Request
Time elapsed between arrival in the postoperative care unit and the first analgesic request via PCA.
Measured: First 24 hours postoperatively
Mean Arterial Pressure (mmHg)
"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."
Measured: Intraoperative and first 24 hours postoperative
Peripheral Oxygen Saturation (SpO₂,%)
"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."
Measured: Intraoperative and first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AKDOĞAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238348
- Sponsor's protocol ID
- 2024/176
- Other IDs
- 2024/276
- Acronym
- SPSIPB-VATS
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 37852626Tulgar 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.
PubMed 36883093Koksal 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.
PubMed 40275145
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07238348
- Acronym / sponsor ID
- SPSIPB-VATS / 2024/176
- Conditions
- Postoperative Pain Management, Video-assisted Thoracoscopic Surgery (VATS), Thoracic Epidural Analgesia, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Serratus Posterior Superior Intercostal Plane Block, Thoracic Epidural Analgesia, Systemic Opioid Analgesia, Video-Assisted Thoracoscopic Surgery, Opioid Consumption, Pain Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioid Consumption
Time frame: 24 hours postoperatively
Total Opioid Consumption at 24 Hours
8 secondary outcomes
Pain Scores
Time frame: 0, 1, 2, 6, 12, and 24 hours after surgery
Need for Rescue Analgesia
Time frame: First 24 hours postoperatively
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: First 24 hours postoperatively
Heart Rate (beats per minute)
Time frame: Intraoperative and first 24 hours postoperative
Quality of Recovery Score (QoR-15)
Time frame: Preoperative baseline and 24 hours postoperative
Time to First Opioid Request
Time frame: First 24 hours postoperatively
Mean Arterial Pressure (mmHg)
Time frame: Intraoperative and first 24 hours postoperative
Peripheral Oxygen Saturation (SpO₂,%)
Time frame: Intraoperative and first 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 37852626Bilal 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.
- Background: PubMed 36883093Tulgar 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.
- Background: PubMed 40275145Koksal 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain Management and Video-assisted Thoracoscopic Surgery (VATS), run by Karadeniz Technical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali AKDOGAN, MD (+905322605414, draliakdogan@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07238348, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.