Chronic Post-thoracotomy Pain, Neuropathic Pain, Postoperative Pain, Acute
Conditions
Brief 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).
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.
Interventions
DRUGSPS block
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.
DRUGSurgical 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.
Sponsors
Medipol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The patients will be blind to the study groups.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption (Fentanyl PCA) | 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. |
| Pain scores (Numerical rating scale-NRS) | 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 |
| Need for rescue analgesia (meperidine) | Postoperative 24 hours period | The secondary aim is to compare rescue analgesia used in the postoperative 24 h. |
| Adverse events | Postoperative 24 hours period | The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use |
| Incidence and severity of Chronic Post-Thoracotomy Pain (CPTP) | 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). |
Countries
Turkey (Türkiye)
Contacts
CONTACTBahadir Ciftci, Assoc Prof, MD
CONTACTAyse Cicek
Outcome results
None listed