Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block After Video-Assisted Thoracoscopic Surgery

NCT05255536 | Recruiting

• 1 other identifier: E.Kurul-E1-22-2371
• 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. In addition, SAPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of SAPB block to be performed with USG in patients who underwent VATS.

Conditions

Serratus Anterior Plane Block; Pain, Postoperative; Thoracic Surgery, Video-Assisted; Local Anesthetic

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)

Serratus Anterior Plan Block with 20 ml %0.25 Bupivacaine

ACTIVE COMPARATOR

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area.

Procedure: Serratus Anterior Plan Block with 20 ml

Serratus Anterior Plan Block with 30 ml %0.25 Bupivacaine

ACTIVE COMPARATOR

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 30 ml 0.25% bupivacaine will be injected into the area.

Procedure: Serratus Anterior Plan Block with 30 ml

Interventions

Serratus Anterior Plan Block with 20 ml PROCEDURE

Superficial serratus anterior plane block with 20 ml will be applied to the patients under real-time ultrasound guidance.

Also known as: Drug

Serratus Anterior Plan Block with 20 ml %0.25 Bupivacaine

Serratus Anterior Plan Block with 30 ml PROCEDURE

Superficial serratus anterior plane block with 30 ml will be applied to the patients under real-time ultrasound guidance.

Also known as: Drug

Serratus Anterior Plan Block with 30 ml %0.25 Bupivacaine

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)

RECRUITING

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

Central Study Contacts

Musa Zengin, MD

CONTACT

903125677233; musazengin@gmail.com

Ali Alagoz, Assoc Prof

CONTACT

+903125677232; mdalagoz@gmail.com

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: April 15, 2024
• Study Completion: May 15, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

TU (1)