- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06657261
Comparison of the Analgesic Efficacy of Chest Wall Blocks in Coronary Artery Bypass Surgery
March 23, 2026 updated by: Ankara City Hospital Bilkent
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey (Türkiye), 06530
- Ankara Bilkent City Hospital
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Ankara, Turkey (Türkiye)
- Ankara bilkent city hospital, Ankara, Çankaya 06530
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: The patient group receiving deep and superficial serratus anterior plane block
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.
|
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.
|
|
Active Comparator: The patient group receiving a combination of deep serratus anterior plane block and transverse thora
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: postoperative 24 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2024
Primary Completion (Actual)
November 1, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
October 23, 2024
First Submitted That Met QC Criteria
October 23, 2024
First Posted (Actual)
October 24, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2026
Last Update Submitted That Met QC Criteria
March 23, 2026
Last Verified
October 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- AsenaIremYildiz2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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