ESP vs SPSIP Block in VATS Analgesia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBursa City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-65 years with ASA physical status I-III who will undergo elective video-assisted thoracoscopic surgery (VATS) will be included.

Disqualifiers

Patients who do not consent to participate in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Postoperative analgesia management(SPSIPB)

    Other intervention

    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.

  • Postoperative analgesia management(ESPB)

    Other intervention

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Serratus posterior superior intercostal plane block (SPSIPB)Active comparator 1 intervention
Group B: Erector spinae plane blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

opioid consumption

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

Secondary outcomes

1

Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.

Time frame
0, 2, 4, 8, 16 and 24 hours
2

Global recovery scoring system (patient satisfaction scale)- QoR-15

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
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.
3

Brief Pain Inventory

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
postoperative third month
4

Hospital Anxiety and Depression Scale (HADS)

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.

Time frame
On the morning of surgery and at the 3rd postoperative month

Other outcomes

Sponsors and contacts

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Bursa City Hospital

Lead sponsor

Ulusoy, Emre, M.D.

Collaborator