Comparison of Combined Serratus Anterior Plane Block and Thoracic Paravertebral Block

NCT05255562 | Completed

• 1 other identifier: E.Kurul-E1-22-2372
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.

  48 hours after surgery

Secondary Outcomes (1)

• Morphine Consumption

  24 hours after surgery

Study Arms (2)

Combined Serratus Anterior Plane Block

ACTIVE COMPARATOR

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.

Procedure: Combined Serratus Anterior Plane Block

Thoracic Paravertebral Block

ACTIVE COMPARATOR

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.

Drug: Thoracic Paravertebral Block

Interventions

Combined Serratus Anterior Plane Block PROCEDURE

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

Also known as: Drug

Combined Serratus Anterior Plane Block

Thoracic Paravertebral Block DRUG

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

Also known as: Drug

Thoracic Paravertebral Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: lead

Study Sites (1)

Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Keçiören, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Musa Zengin, MD

  Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: February 15, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 16, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

TU (1)