Bursa City Hospital
Bursa, Nilüfer, 16110, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07232940
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure performed through small thoracic incisions, but postoperative pain remains significant due to tissue and rib trauma. Poorly controlled pain may lead to chronic postoperative pain; therefore, optimal analgesia is essential.
According to PROSPECT guidelines, erector spinae plane block (ESPB) or paravertebral block (PVB) are recommended for VATS. The recently defined serratus posterior superior intercostal plane block (SPSIPB) provides analgesia between C3-T10 levels, but its efficacy compared with ESPB has not been studied.
This study aims to compare postoperative analgesic efficacy and patient satisfaction between ESPB and SPSIPB in VATS patients.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Bursa, Nilüfer, 16110, Turkey (Türkiye)
Location status: Recruiting
Video-assisted thoracoscopic surgery (VATS) is a minimally invasive procedure performed through small thoracic incisions, but postoperative pain remains significant due to tissue and rib trauma. Poorly controlled pain may lead to chronic postoperative pain; therefore, optimal analgesia is essential.
According to PROSPECT guidelines, erector spinae plane block (ESPB) or paravertebral block (PVB) are recommended for VATS. The recently defined serratus posterior superior intercostal plane block (SPSIPB) provides analgesia between C3-T10 levels, but its efficacy compared with ESPB has not been studied.
This study aims to compare postoperative analgesic efficacy and patient satisfaction between ESPB and SPSIPB in VATS patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with coagulopathy
Patients with a history of local anesthetic allergy or toxicity
Patients with hepatic or renal failure
Patients with uncontrolled diabetes
Patients with uncontrolled hypertension
Mentally disabled patients
Patients receiving chronic pain treatment (opioid users)
Patients using antidepressant medication
Patients with neuropathic pain
Mentally disabled patients
Presence of infection at the injection site
Pregnant or breastfeeding women, or those with suspected pregnancy
A high-frequency linear ultrasound probe (GE ML6-15-D Matrix Linear) will be covered with a sterile sheath, and the T3 level will be identified just above the medial border of the scapula. After visualizing the trapezius, rhomboid major, and serratus posterior superior muscles (from superficial to deep), 30 mL of 0.25% bupivacaine (Buvicaine 0.5%®, Polifarma, Tekirdağ, Türkiye) containing 7.5 µg epinephrine (1:200,000) (Adrenalin Bas Galen®; Galen, İstanbul, Türkiye) will be administered as the local anesthetic solution.
A high-frequency linear ultrasound probe (GE ML6-15-D Matrix Linear) will be covered with a sterile sheath. At the T5 vertebral level, the erector spinae muscle layers and the transverse process of the T5 vertebra, located immediately beneath them, will be identified. After confirming the transverse process, 30 mL of 0.25% bupivacaine (Buvicaine 0.5%®, Polifarma, Tekirdağ, Türkiye) containing 7.5 µg epinephrine (1:200,000) (Adrenalin Bas Galen®; Galen, İstanbul, Türkiye) will be administered as the local anesthetic solution.
Time frame: 0, 2, 4, 8, 16 and 24 hours
Tramadol will be prepared as 5mg/ml and patient-controlled analgesia will be administered without basal infusion, with a locking time of 20 minutes and a bolus dose of 10mg.
Time frame: 0, 2, 4, 8, 16 and 24 hours
Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
Time frame: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
Researchers will use the Turkish version of the Quality Improvement Survey/QoR-15. PART A: Participants will be asked by researchers how they felt in the last 24 hours.(0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Participants will be asked by the researchers whether they have experienced any of the following in the last 24 hours. (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed
Time frame: postoperative third month
Brief Pain Inventory (BPI-Short Form) At the postoperative third month, patients will be contacted by phone, and chronic pain will be assessed using the Brief Pain Inventory - Short Form (BPI-SF).
The BPI-SF consists of two main components:
Pain Severity Score (0-10):
Four numeric rating items evaluating worst, least, average, and current pain. Higher scores indicate more severe pain.
Pain Interference Score (0-10):
Seven numeric rating items evaluating interference with general activity, mood, walking ability, normal work, sleep, relations with others, and enjoyment of life.
Higher scores indicate greater interference with daily activities.
Time frame: On the morning of surgery and at the 3rd postoperative month
The Hospital Anxiety and Depression Scale (HADS) was administered preoperatively and at the 3rd postoperative month. The change between these two time points will be included in the analysis.
HADS consists of 14 items, divided into two subscales:
HADS-Anxiety (HADS-A): 7 items
HADS-Depression (HADS-D): 7 items
Each item is scored on a 0-3 Likert scale, resulting in:
HADS-A total score range: 0-21
HADS-D total score range: 0-21
Higher scores indicate worse anxiety or worse depression.
Contact information is provided by the study sponsor or research team.
Emre ULUSOY
CONTACT
Eralp Çevikkalp
CONTACT
Bursa City Hospital
Other Gov
Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia Management in Patients Undergoing Video-Assisted Thoracoscopic Surgery
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