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
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.
- 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