- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07436806
SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery
March 6, 2026 updated by: Bahadir Ciftci, Medipol University
Evaluation of Serratus Posterior Superior (SPS) Block Versus Surgical Intercostal Blockade in Preventing Chronic Post-Thoracotomy Pain After Video-Assisted Thoracoscopic Surgery (VATS): A Randomized, Prospective, Comparative Study.
This study aims to evaluate the efficacy of ultrasound-guided Serratus Posterior Superior (SPS) block compared to surgeon-administered intercostal blockade in preventing chronic pain at 3, 6, and 12 months following Video-Assisted Thoracoscopic Surgery (VATS).
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Although VATS is a minimally invasive technique, chronic post-thoracotomy pain (CPTP) remains a significant complication due to intercostal nerve injury.
This study investigates whether the preemptive analgesic effect of the SPS block, performed under ultrasound guidance before surgery, reduces the incidence and severity of chronic pain more effectively than standard surgical intercostal blocks.
Secondary objectives include assessing acute pain scores (VAS/NRS) within the first 24 hours, total opioid consumption, and duration of hospital stay.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
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
- Name: Bahadir Ciftci, Assoc Prof, MD
- Phone Number: +905343736865
- Email: bciftci@medipol.edu.tr
Study Contact Backup
- Name: Ayse Cicek
Study Locations
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey (Türkiye), 34070
- Recruiting
- Istanbul Medipol University Hospital
-
Contact:
- Bahadir Ciftci, MD
- Phone Number: +905325034428
- Email: bciftci@medipol.edu.tr
-
-
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
Description
Inclusion Criteria:
- ASA physical status I-III.
- Scheduled for elective unilateral Video-Assisted Thoracoscopic Surgery (VATS).
Exclusion Criteria:
- History of allergy to local anesthetics.
- Pre-existing chronic pain syndrome or neuropathic pain.
- Psychiatric disorders affecting pain assessment.
- Coagulation disorders.
- Previous thoracic surgery on the same side.
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SPS Block Group
SPS Block will be performed at the end of the surgery
|
30 mL of 0.25% Bupivacaine will be injected into the plane between the Serratus Posterior Superior muscle and the intercostal muscles at the scapular level.
|
|
Active Comparator: Surgical Intercostal Blockade Group
Surgical Intercostal Blockade will be performed at the end of the surgery by the surgeon
|
At the end of the operation, the surgeon will perform an injection of a total of 30 mL of 0.25% Bupivacaine into three intercostal nerves above and below the incision site under direct thoracoscopic visualization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)
Time Frame: Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.
|
The primary aim is to compare incidence and severity of Chronic Post-Thoracotomy Pain with McGill Pain Questionnaire (MPQ).
|
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for rescue analgesia (meperidine)
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
|
Postoperative 24 hours period
|
|
Opioid consumption (Fentanyl PCA)
Time Frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
|
The primary aim is to compare postoperative opioid consumption from the PCA device.
|
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
|
|
Pain scores (Numerical rating scale-NRS)
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
The secondary aim is to compare NRS at the postoperative 24 h.
Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt).
The NRS scores will be recorded
|
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
|
Adverse events
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use
|
Postoperative 24 hours period
|
|
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)
Time Frame: Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.
|
The secondary aim is to compare ncidence and severity of Chronic Post-Thoracotomy Pain with Neuropathic pain characteristics using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) and McGill Pain Questionnaire (MPQ).
|
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.
- Dogan G, Kucuk O, Kayir S, Dal GC, Ciftci B, Zengin M, Alagoz A. Serratus posterior superior intercostal plane block versus thoracic paravertebral block for pain management after video-assisted thoracoscopic surgery: a randomized prospective study. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844647. doi: 10.1016/j.bjane.2025.844647. Epub 2025 Jun 3.
- Cevikkalp E, Ulusoy E, Karakaya M, Ekinci M, Dikici M. Serratus posterior superior intercostal block as a component of multimodal analgesia in thoracotomy. Minerva Anestesiol. 2026 Jan 27. doi: 10.23736/S0375-9393.25.19490-X. Online ahead of print. No abstract available.
- Ozen V, Turan EI, Alver S, Sahin AS, Ciftci B. Combination of Fascial Plane Blocks Including Serratus Posterior Superior Intercostal Plane Block for Pediatric Thoracic Analgesia: Two Case Reports. A A Pract. 2026 Jan 14;20(1):e02144. doi: 10.1213/XAA.0000000000002144. eCollection 2026 Jan 1.
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 (Actual)
March 1, 2026
Primary Completion (Estimated)
November 20, 2026
Study Completion (Estimated)
December 10, 2026
Study Registration Dates
First Submitted
February 13, 2026
First Submitted That Met QC Criteria
February 23, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
March 10, 2026
Last Update Submitted That Met QC Criteria
March 6, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medipol Hospital 40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We will not plan to share IPD
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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