Comparison Paravertebral and Serratus Anterior Plane Block in Video-assisted Thoracoscopic Surgery.

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer (NSCLC); Lung Adenocarcinoma; Video Assisted Thoracic Surgery (VATS)
• Interventions: Drug: Bupivacaine; Drug: Morphine; Drug: Paracetamol; Drug: Diklofenak Sodyum

• Registration Number: NCT07002788
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Study Start: 2024-12-01
• Study First Submitted: 2025-03-16
• Status Verified: 2025-04
• Study First Submitted QC: 2025-05-26
• Last Update Submitted: 2025-05-26
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paravertebral block	Bupivacaine	Paravertebral block: After the patient is in the lateral decubitus position and the necessary antiseptic conditions are provided, the linear probe of the ultrasound will be placed between two transverse processes in the paramedian plane on the side to be operated on, and the transverse processes and the superior costotransverse ligament and pleura will be visualized at the level of the thoracic 6-7 vertebrae. The 22 gauge 50 mm needle will be advanced in-plane with ultrasonography until it passes the superior costotransverse ligament, and 20 ml of 0.5% bupivacaine hydrochloride will be injected while the needle tip is in the thoracic paravertebral area. The spread of the local anesthetic drug and the collapse movement of the pleura will be observed on ultrasonography.
Paravertebral block	Morphine	Paravertebral block: After the patient is in the lateral decubitus position and the necessary antiseptic conditions are provided, the linear probe of the ultrasound will be placed between two transverse processes in the paramedian plane on the side to be operated on, and the transverse processes and the superior costotransverse ligament and pleura will be visualized at the level of the thoracic 6-7 vertebrae. The 22 gauge 50 mm needle will be advanced in-plane with ultrasonography until it passes the superior costotransverse ligament, and 20 ml of 0.5% bupivacaine hydrochloride will be injected while the needle tip is in the thoracic paravertebral area. The spread of the local anesthetic drug and the collapse movement of the pleura will be observed on ultrasonography.
Paravertebral block	Paracetamol	Paravertebral block: After the patient is in the lateral decubitus position and the necessary antiseptic conditions are provided, the linear probe of the ultrasound will be placed between two transverse processes in the paramedian plane on the side to be operated on, and the transverse processes and the superior costotransverse ligament and pleura will be visualized at the level of the thoracic 6-7 vertebrae. The 22 gauge 50 mm needle will be advanced in-plane with ultrasonography until it passes the superior costotransverse ligament, and 20 ml of 0.5% bupivacaine hydrochloride will be injected while the needle tip is in the thoracic paravertebral area. The spread of the local anesthetic drug and the collapse movement of the pleura will be observed on ultrasonography.
Paravertebral block	Diklofenak Sodyum	Paravertebral block: After the patient is in the lateral decubitus position and the necessary antiseptic conditions are provided, the linear probe of the ultrasound will be placed between two transverse processes in the paramedian plane on the side to be operated on, and the transverse processes and the superior costotransverse ligament and pleura will be visualized at the level of the thoracic 6-7 vertebrae. The 22 gauge 50 mm needle will be advanced in-plane with ultrasonography until it passes the superior costotransverse ligament, and 20 ml of 0.5% bupivacaine hydrochloride will be injected while the needle tip is in the thoracic paravertebral area. The spread of the local anesthetic drug and the collapse movement of the pleura will be observed on ultrasonography.
serratus anterior plane block	Bupivacaine	In patients who will undergo serratus anterior plane block, after the necessary antiseptic conditions are provided in the lateral decubitus position, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the anatomical neurofascial space between the serratus anterior and latissimus dorsalis muscle with a 10 cm long block needle in the mid-axillary line between the 4th and 5th ribs using the linear probe of the ultrasound.
serratus anterior plane block	Morphine	In patients who will undergo serratus anterior plane block, after the necessary antiseptic conditions are provided in the lateral decubitus position, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the anatomical neurofascial space between the serratus anterior and latissimus dorsalis muscle with a 10 cm long block needle in the mid-axillary line between the 4th and 5th ribs using the linear probe of the ultrasound.
serratus anterior plane block	Paracetamol	In patients who will undergo serratus anterior plane block, after the necessary antiseptic conditions are provided in the lateral decubitus position, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the anatomical neurofascial space between the serratus anterior and latissimus dorsalis muscle with a 10 cm long block needle in the mid-axillary line between the 4th and 5th ribs using the linear probe of the ultrasound.
serratus anterior plane block	Diklofenak Sodyum	In patients who will undergo serratus anterior plane block, after the necessary antiseptic conditions are provided in the lateral decubitus position, 30 ml of 0.25% bupivacaine hydrochloride will be injected into the anatomical neurofascial space between the serratus anterior and latissimus dorsalis muscle with a 10 cm long block needle in the mid-axillary line between the 4th and 5th ribs using the linear probe of the ultrasound.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain Scores (VAS)	Within the first 24 hours after surgery	Pain assessment will be performed by Res. Asst. Dr. Rabia Çakmak at the 1st, 3rd, 6th, 12th, and 24th hours postoperatively. Pain scores will be evaluated at rest and during coughing using the Visual Analog Scale (VAS), where 0 = no pain and 10 = worst imaginable pain.
Total Postoperative Morphine Consumption	Within the first 24 hours after surgery	Total morphine consumption in the first 24 hours after surgery will be recorded by the patient-controlled analgesia (PCA) device.

Secondary Outcome Measures

Name	Time	Method
Total Rescue Analgesic Use	Within the first 24 hours after surgery	Amount of additional analgesic medication (excluding PCA-administered morphine) required in the first 24 hours postoperatively will be recorded.

Trial Locations

Locations (1)

Hacettepe Üniversitesi; 🇹🇷 Ankara, Turkey