Clinical trial NCT06657261: Comparison of the Analgesic Efficacy of Chest Wall Blocks in Coronary Artery Bypass Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Serratus Anterior Muscle Plane Block
Transversus Thoracis Muscle Plane Block
Postoperative Analgesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: "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."
Primary purpose: PREVENTION

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.

Detailed description: Postoperative pain is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (CABG) surgery. If effective respiratory function cannot be maintained in patients with high pain levels, atelectasis, cardiac ischemia, and arrhythmias may be observed. This prolongs the hospital discharge time of patients and increases the frequency of postoperative pulmonary complications and postoperative morbidity. Moreover, if postoperative acute pain is not adequately treated, chronic pain may develop after surgery, preventing patients from regaining their normal activities for a long time. In addition to medications, various neuroaxial and peripheral nerve blocks can be used in cardiac surgery. The use of intraoperative heparin limits the application of neuroaxial anesthesia (thoracic epidural and intrathecal opioids) and paravertebral block due to potential complications. Nevertheless, studies have shown their benefits in reducing cardiac and pulmonary complications. Recently, fascial plane nerve blocks, which are alternatives to these methods, have gained more popularity in cardiovascular surgery. These blocks include pectoral nerve blocks, serratus anterior plane block (SAPB), erector spinae plane block (ESPB), transverse thoracic plane blocks (TTMP), pecto-intercostal fascial blocks (PIF), and intercostal nerve blocks. The inability to effectively prevent postoperative pain in cardiac surgery has led not only to the exploration of new block applications but also to the combination of these blocks.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
city: Ankara
country: Turkey
facility: Ankara bilkent city hospital, Ankara, Çankaya 06530
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.