Chronic Post-thoracotomy PainNCT07436806
SPS Block vs. Surgical Intercostal Block for Chronic Pain After Thoracoscopic Surgery
A study testing SPS block and Surgical Intercostal Blockade. in people with Chronic Post-thoracotomy Pain and Neuropathic Pain, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Post-thoracotomy Pain, Neuropathic Pain, Postoperative Pain, Acute
- What is being tested?
- SPS block and Surgical Intercostal Blockade.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 10 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- ASA physical status I-III.
- Scheduled for elective unilateral Video-Assisted Thoracoscopic Surgery (VATS).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayse Cicek contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
Bahadir Ciftci, MD, +905325034428, bciftci@medipol.edu.tr
About this study
Official title: 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).
Read the 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.
- Being tested
- SPS block, Surgical Intercostal Blockade.
- Medical subject headings
- Neuralgia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPS blockDrug
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.
Surgical Intercostal Blockade.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SPS Block Group | Experimental | SPS Block will be performed at the end of the surgery Receives: Drug: SPS block |
| Surgical Intercostal Blockade Group | Active comparator | Surgical Intercostal Blockade will be performed at the end of the surgery by the surgeon Receives: Drug: Surgical Intercostal Blockade. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)
The primary aim is to compare incidence and severity of Chronic Post-Thoracotomy Pain with McGill Pain Questionnaire (MPQ).
Measured: Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.
Secondary outcomes (5)
Opioid consumption (Fentanyl PCA)
The primary aim is to compare postoperative opioid consumption from the PCA device.
Measured: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Pain scores (Numerical rating scale-NRS)
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
Measured: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
Need for rescue analgesia (meperidine)
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Measured: Postoperative 24 hours period
Adverse events
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use
Measured: Postoperative 24 hours period
Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP)
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).
Measured: Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) at 3, 6, and 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Mar 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Post-thoracotomy PainStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two models for this study. The first group is the SPS block. The second one is the Surgical Intercostal Blockade group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436806
- Sponsor's protocol ID
- Medipol Hospital 40
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not plan to share IPD
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.
PubMed 38240640Dogan 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.
PubMed 40473018Cevikkalp 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 Mar;92(3):239-241. doi: 10.23736/S0375-9393.25.19490-X. Epub 2026 Jan 27. No abstract available.
PubMed 41591369Ozen 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.
PubMed 41533022
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07436806
- Acronym / sponsor ID
- Medipol Hospital 40
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (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 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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two models for this study. The first group is the SPS block. The second one is the Surgical Intercostal Blockade group.
| Arm | Type | Receives |
|---|---|---|
| SPS Block Group | Experimental | Drug: SPS blockSPS Block will be performed at the end of the surgery |
| Surgical Intercostal Blockade Group | Active comparator | Drug: Surgical Intercostal Blockade.Surgical Intercostal Blockade will be performed at the end of the surgery by the surgeon |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I-III.
- Scheduled for elective unilateral Video-Assisted Thoracoscopic Surgery (VATS).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPS block30 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. | Drug | SPS Block Group |
| Surgical Intercostal Blockade.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. | Drug | Surgical Intercostal Blockade Group |
Primary outcome
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).
5 secondary outcomes
Opioid consumption (Fentanyl PCA)
Time frame: 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
Need for rescue analgesia (meperidine)
Time frame: Postoperative 24 hours period
Adverse events
Time frame: 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.
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 10 Mar 2026.
- Background: PubMed 38240640Ciftci 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.
- Background: PubMed 40473018Dogan 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.
- Background: PubMed 41591369Cevikkalp 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 Mar;92(3):239-241. doi: 10.23736/S0375-9393.25.19490-X. Epub 2026 Jan 27. No abstract available.
- Background: PubMed 41533022Ozen 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.
- Individual participant dataSharing planned: No. We will not plan to share IPD
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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.
Ayse Cicek contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPS block and Surgical Intercostal Blockade. in people with Chronic Post-thoracotomy Pain and Neuropathic Pain, run by Medipol University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Bahadir Ciftci, Assoc Prof, MD (+905343736865, bciftci@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT07436806, which also lists 4 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 10 Mar 2026.