Comparison of the Analgesic Efficacy of Chest Wall Blocks in Coronary Artery Bypass Surgery

NCT06657261 | Completed

• 1 other identifier: AsenaIremYildiz2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, the analgesic effects of the Transverse Thoracic Muscle Plane Block and deep Serratus Anterior Plane versus deep and superficial Serratus Anterior Plane applications, which will be performed under ultrasound guidance in patients undergoing coronary artery bypass surgery with sternotomy, will be compared and evaluated.

Conditions

Serratus Anterior Muscle Plane Block; Transversus Thoracis Muscle Plane Block; Postoperative Analgesia; Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (1)

• Comparison of the Analgesic Efficacy of Deep and Superficial Serratus Anterior Plane Block with the Combination of Deep Serratus Anterior Plane and Transverse Thoracic Muscle Plane Block in Coronary Artery Bypass Surgery: A Randomized Controlled Trial

  Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher VAS scores indicate worse pain outcomes. Pain scores will be recorded by the pain nurse in the postoperative post-anesthesia care unit (PACU), where patients are routinely monitored for 24 hours. Additional postoperative analgesic consumption and patient satisfaction will also be assessed. For descriptive analysis, pain intensity will be categorized as mild (VAS \<3), mild to moderate (VAS 3-6), and moderate to severe (VAS \>6).

  postoperative 24 hours

Study Arms (2)

The patient group receiving deep and superficial serratus anterior plane block

ACTIVE COMPARATOR

In this group, the ultrasound probe will be placed on the 5th rib in the mid-axillary line. After visualizing the muscle structures down to the rib (latissimus dorsi, teres major, and serratus anterior), the needle will be advanced using the in-plane technique to two separate areas on the 5th rib: the superficial and deep fascial planes of the serratus anterior muscle. A total of 20 ml of 0.25% bupivacaine will be injected into both areas. The procedure will be performed bilaterally.

Procedure: The patient group receiving deep and superficial serratus anterior plane block

The patient group receiving a combination of deep serratus anterior plane block and transverse thora

ACTIVE COMPARATOR

In this group, for the TTMP block, the ultrasound probe will be placed on the midclavicular line at the 3rd or 4th intercostal space, where the pleura, pectoralis major, and intercostal muscles will be visualized. A lateral-to-medial scan will be performed to visualize the hypoechoic TTMP located deep to the intercostal muscle and above the pleura. The needle target will be the plane between the internal intercostal muscle and the TTMP. In this area, 10 ml of 0.25% bupivacaine will be injected. The procedure will be performed bilaterally. For the deep SAPB, the ultrasound probe will be placed on the 5th rib in the mid-axillary line. After visualizing the muscle structures down to the rib (latissimus dorsi, teres major, and serratus anterior), the needle will be advanced using the in-plane technique to the fascial plane deep to the serratus anterior muscle on the 5th rib. In this area, 10 ml of 0.25% bupivacaine will be injected. The procedure will be performed bilaterally.

Procedure: The patient group receiving a combination of deep serratus anterior plane block and transverse thoracic muscle plane block

Interventions

The patient group receiving deep and superficial serratus anterior plane block PROCEDURE

The ultrasound device to be used , the type of single-use ultrasound-compatible block needle, the type of local anesthetic agent to be administered to the patient, the concentration of the local anesthetic agent, and the total dose of the local anesthetic agent to be administered to the patient will be the same.

The patient group receiving deep and superficial serratus anterior plane block

The patient group receiving a combination of deep serratus anterior plane block and transverse thoracic muscle plane block PROCEDURE

The ultrasound device to be used , the type of single-use ultrasound-compatible block needle, the type of local anesthetic agent to be administered to the patient, the concentration of the local anesthetic agent, and the total dose of the local anesthetic agent to be administered to the patient will be the same.

The patient group receiving a combination of deep serratus anterior plane block and transverse thora

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-80
• Patients with ASA score I-II-III
• Patients with a body mass index (BMI) between 18-35
• Patients undergoing sternotomy in the operating room

You may not qualify if:

• Patients under 18 and over 80 years of age
• Patients with an ASA score of IV or higher
• Patients with advanced comorbidities
• Patients with a history of bleeding diathesis
• Patients using medications that cause bleeding disorders
• Patients with infections in the area where the block will be performed
• Patients with a body mass index (BMI) below 18 or above 35

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (2)

Ankara Bilkent City Hospital

Ankara, 06530, Turkey (Türkiye)

Location

Ankara bilkent city hospital, Ankara, Çankaya 06530

Ankara, Turkey (Türkiye)

Location

Related Publications (6)

• Hamed MA, Boules ML, Sobhy MM, Abdelhady MA. The Analgesic Efficacy of Ultrasound-Guided Bilateral Transversus Thoracic Muscle Plane Block After Open-Heart Surgeries: A Randomized Controlled Study. J Pain Res. 2022 Mar 5;15:675-682. doi: 10.2147/JPR.S355231. eCollection 2022.

  PMID: 35281480 BACKGROUND

• Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector spinae plane block provides comparable analgesia to thoracic paravertebral block following thoracotomy: a single center randomized controlled double-blind study. Ann Transl Med. 2019 Apr;7(8):174. doi: 10.21037/atm.2019.03.53.

  PMID: 31168455 BACKGROUND

• Abdallah NM, Bakeer AH, Youssef RB, Zaki HV, Abbas DN. Ultrasound-guided continuous serratus anterior plane block: dexmedetomidine as an adjunctive analgesic with levobupivacaine for post-thoracotomy pain. A prospective randomized controlled study. J Pain Res. 2019 Apr 30;12:1425-1431. doi: 10.2147/JPR.S195431. eCollection 2019.

  PMID: 31118760 BACKGROUND

• Jannati M, Attar A. Analgesia and sedation post-coronary artery bypass graft surgery: a review of the literature. Ther Clin Risk Manag. 2019 Jun 20;15:773-781. doi: 10.2147/TCRM.S195267. eCollection 2019.

  PMID: 31417264 BACKGROUND

• Caruso TJ, Lawrence K, Tsui BCH. Regional anesthesia for cardiac surgery. Curr Opin Anaesthesiol. 2019 Oct;32(5):674-682. doi: 10.1097/ACO.0000000000000769.

  PMID: 31356362 BACKGROUND

• Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.

  PMID: 32062870 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: "The anesthesia and surgical method will be the same for both patient groups. One group of patients will receive deep and superficial serratus anterior plane block. The other group will receive a combination of deep serratus anterior plane block and transverse thoracic muscle plane block. Postoperative visual pain scores will be observed for both groups. At the end of the study, the analgesic efficacy of the two groups will be compared."

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 25, 2026

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)