Clinical trial NCT07002788: Comparison Paravertebral and Serratus Anterior Plane Block in Video-assisted Thoracoscopic Surgery.
Official title: Comparison of Postoperative Analgesic Efficacy of Paravertebral Block and Serratus Anterior Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer (NSCLC)
Lung Adenocarcinoma
Video Assisted Thoracic Surgery (VATS)
Keywords: paravertebral block
serratus anterior plane block
lung cancer
video-assisted thoracoscopic surgery
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracoscopic surgery (VATS) is a minimally invasive alternative to thoracotomy that emerged in the early 1990s, aiming to reduce surgical stress and postoperative pain. While VATS generally results in less pain than thoracotomy, patients may still experience significant discomfort. Effective pain control remains crucial in VATS to minimize postoperative complications, especially pulmonary and cardiac events, which can arise from inadequate ventilation and impaired sputum clearance due to pain.

Various strategies have been developed to manage postoperative pain, with multimodal approaches-combining regional or peripheral blocks with systemic analgesics such as NSAIDs and adjuvants-now considered standard. Among regional techniques, serratus anterior plane (SAP) block and thoracic paravertebral block (PVB) are commonly used. SAP block targets the thoracodorsal, long thoracic, and T2-T9 spinal nerves between the latissimus dorsi and serratus anterior muscles, providing effective anterolateral chest wall analgesia. PVB targets intercostal nerves within the paravertebral space and has shown superior pain control and improved lung function compared to systemic opioids or intrapleural local anesthetics.

At our center, both SAP and PVB are routinely used for postoperative analgesia in VATS procedures for patients with lung masses. Pain levels will be assessed using the Visual Analog Scale (VAS), a reliable tool for evaluating both acute and chronic pain, unaffected by age or gender.

This study aims to compare the effectiveness of SAP and PVB blocks in terms of postoperative pain, opioid requirements, and block-related complications in patients undergoing VATS under general anesthesia. The research is observational and will not alter routine clinical practices.

Detailed description: The study is a single-center randomized single-blind prospective clinical study, and after patients with appropriate criteria are included in the study; they will be assigned to either the paravertebral block arm or the serratus anterior plane block arm of the study using an internet-based randomization program (randomizer.org). Patients will not know which arm of the study they are in, but researchers who will evaluate the treatment outcome will know which block was applied to which patient. Paravertebral block or serratus anterior plane block will be applied to the patients under general anesthesia after VATS according to the arm they are in. After the patients are taken to the room, non-invasive arterial blood pressure, electrocardiogram, and peripheral oxygen saturation monitoring will be performed before general anesthesia. This is the routine monitoring method applied before anesthesia application. Standard routine general anesthesia will be applied to the patients. No change will be made in the general anesthesia approach due to the study.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-64 who gave consent to participate in the study
* Patients between the ages of 65-90 who received a score of 24 or more from the mini mental test and gave consent to participate in the study
* ASA 1-3 patients

Exclusion Criteria:

* Those with neuropathy,
* Those with renal failure,
* Those with liver failure,
* Those with coagulopathy,
* Those with local anesthetic allergy,
* Those with infection in the area where the procedure will be performed,
* Those with congenital muscle absence in the area where the block will be performed
* Patients who did not give consent to participate in the study

Primary outcomes:
measure: Postoperative Pain Scores (VAS)
timeFrame: Within the first 24 hours after surgery
measure: Total Postoperative Morphine Consumption
timeFrame: Within the first 24 hours after surgery
Secondary outcomes:
measure: Total Rescue Analgesic Use
timeFrame: Within the first 24 hours after surgery
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe Üniversitesi
Study officials:
affiliation: Hacettepe University
name: murat izgi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
citation: Gagliese L, Katz J. Age differences in postoperative pain are scale dependent: a comparison of measures of pain intensity and quality in younger and older surgical patients. Pain. 2003 May;103(1-2):11-20. doi: 10.1016/s0304-3959(02)00327-5.
citation: Sihoe ADL. Video-assisted thoracoscopic surgery as the gold standard for lung cancer surgery. Respirology. 2020 Nov;25 Suppl 2:49-60. doi: 10.1111/resp.13920. Epub 2020 Jul 30.
citation: Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.