ESP vs SPSIP Block in VATS Analgesia

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other Postoperative analgesia management(SPSIPB)
  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
• Other Postoperative analgesia management(ESPB)
  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

Primary outcome measures

• opioid consumption [Time frame: 0, 2, 4, 8, 16 and 24 hours]

Secondary outcome measures (4)

• Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") [Time frame: 0, 2, 4, 8, 16 and 24 hours]
• Global recovery scoring system (patient satisfaction scale)- QoR-15 [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.]
• Brief Pain Inventory [Time frame: postoperative third month]
• Hospital Anxiety and Depression Scale (HADS) [Time frame: On the morning of surgery and at the 3rd postoperative month]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• Patients who do not consent to participate in the study

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Bursa City Hospital — Bursa

Publications

• Mehta S, Jen TTH, Hamilton DL. Regional analgesia for acute pain relief after open thoracotomy and video-assisted thoracoscopic surgery. BJA Educ. 2023 Aug;23(8):295-303. doi: 10.1016/j.bjae.2023.05.001. Epub 2023 Jun 22. No abstract available. PMID 37465231
• Wong MKH, Sit AKY, Au TWK. Minimally invasive thoracic surgery: beyond surgical access. J Thorac Dis. 2018 Jun;10(Suppl 16):S1884-S1891. doi: 10.21037/jtd.2018.05.196. PMID 30026975
• Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27. PMID 24288340

Identifiers

NCT: NCT07232940 · Bursa City Hospital 001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗