Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block

NCT ID: NCT05255562

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2023-05-16

Brief Summary

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB), and erector spinae plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. There are two techniques for SAPB application. In Deep SAPB (DSAPB) application, a local anesthetic agent is given under the serratus anterior muscle. In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle. Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry. The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other. Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB, as in the multimodal analgesia method. This study seeks to evaluate the effect of TPVB and combined SAPB (CSAPB) after VATS.

Conditions

Pain, Postoperative; Serratus Anterior Plane Block; Thoracic Paravertebral Block; Multimodal Analgesia; Thoracic Surgery, Video-Assisted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Combined Serratus Anterior Plane Block

In patients who are planned to have combined deep and superficial serratus anterior plane block, following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 15 ml 0.25% bupivacaine will be injected into the area. Then, with the same needle, will be returned 1-2 cm from the deep serratus anterior area to the superficial serratus anterior area above the serratus anterior muscle and injected 2 ml normal saline for hydrodissection. Finally, 15 ml of 0.25% bupivacaine will be injected for the superficial serratus anterior block into the interfacial area.

Group Type: ACTIVE_COMPARATOR

Combined Serratus Anterior Plane Block

Intervention Type: PROCEDURE

Combined deep and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.

Thoracic Paravertebral Block

In patients who are planned to have a thoracic paravertebral block, the needle will be advanced to the paravertebral area with ultrasound-guided in-plane technique. 30 ml of 0.25% bupivacaine will be injected into this area.

Group Type: ACTIVE_COMPARATOR

Thoracic Paravertebral Block

Intervention Type: DRUG

Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

Interventions

Combined Serratus Anterior Plane Block

Combined deep and superficial serratus anterior plane block will be applied to the patients under real-time ultrasound guidance.

Intervention Type: PROCEDURE

Thoracic Paravertebral Block

Thoracic paravertebral block will be applied to the patients under real-time ultrasound guidance.

Intervention Type: DRUG

Other Intervention Names

Drug; Drug

Eligibility Criteria

Inclusion Criteria

• 18 to 65 years old
• ASA physical status I-II-III
• BMI 18 to 30 kg/m2
• Elective video-assisted thoracoscopic surgery

Exclusion Criteria

• Patient refusing the procedure
• Emergency surgery
• Chronic opioid or analgesic use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Musa Zengin

Principal İnvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Musa Zengin, MD

Role: PRINCIPAL_INVESTIGATOR

Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

Locations

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E.Kurul-E1-22-2372

Identifier Type: -

Identifier Source: org_study_id