- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907798
Serratus Anterior Plan Block (SAP) and Pectoralis (PECSI-II) Blocks on Left Internal Mammarian Artery (LIMA) Blood Flow
January 20, 2025 updated by: Arzu Esen Tekeli, Yuzuncu Yıl University
Effect of Serratus Anterior Plan Block (SAP) and Pectoralis (PECSI-II) Peripheral Blocks on Left Internal Mammarian Artery (LIMA) Blood Flow in Coronary Bypass Surgery
To investigate whether the anterior chest wall blocks performed before the surgery have an effect on the LIMA (left internal mammarian artery) blood flow in patients who will undergo coronary artery bypass surgery.
Study Overview
Detailed Description
Coronary artery bypass grafting (CABG), also known as heart bypass surgery, is a procedure performed to improve reduced blood flow due to narrowing of the coronary arteries.
The left internal mammary artery (LIMA) is generally the preferred perforator artery for grafting of the left anterior descending (LAD) coronary artery from the coronary arteries.
However, spasm during the release phase for anastomosis often complicates surgical dissection and anastomosis, and adversely affects flow dynamics (1) LIMA has been used as an important potential graft in coronary artery bypass graft (CABG) surgery since the 1970s.
LIMA has a potent biological function through the production of vasodilator and platelet inhibitory factors.
LIMA's feature of having less fenestration, lower intimal hyperplasia tendency and less permeability in intercellular connections prevents lipoproteins from entering the subendothelial space (2) The use of ultrasound in anesthesia practice, especially for analgesia, is increasingly popular.
The sonoanatomical dominance of anesthetists on regional structures is increasing, especially with plan blocks, a new one being defined every day.
The primary aim of this study was to investigate the effect of the ultrasound guided papaverine application method and the traditional method of topical papaverine application on the LIMA flow measured before and after anastomosis.
Papaverine will be administered to all patients after the block procedure at the beginning of the surgical procedure.
Study Type
Interventional
Enrollment (Actual)
90
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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-
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Van, Turkey, 65100
- Arzu Esen Tekeli
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-
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:
- Agreeing to participate in the study
- 20-65 years old
- ASA I-II-III
- Coronary artery bypass grafting will be performed
Exclusion Criteria:
- Refusal to participate in the study
- Patients under the age of 20, over the age of 65
- presence of pregnancy
- Bleeding diathesis
- Liver or kidney failure
- Acute and bleeding patients Those who receive inotropic support starting from the preoperative period
- BMI ≥30
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: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group PECS
placing the ultrasound probe in the midclavicular line and in the parasagittal plane, After identifying the second and third ribs by sliding the ultrasound probe caudally, the lower end will be rotated towards the axilla to make the probe parallel to the deltopectoral groove.
Combined with the in-plane technique, this rotation provides better extension to the intercostobrachial nerve.
The tip of the needle will be inserted into the interpectoral fascial plane (between pectoralis major and minor).
The needle will be advanced from the interpectoral fascial plane to the fascial plane between the pectoralis minor and the serratus anterior.
10 mL of local anesthetic (Bupivacaine) will be applied to the PECS I area and 20 mL to the PECS II area.
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30 minutes after induction
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Active Comparator: Group SA
It will be positioned to stand at the head of the patient or to one side of the patient and to see the ultrasound screen easily.
High-frequency linear probe and 80 mm blunt-tipped needle will be placed cauda-cranially or cranially-caudal with in-plane technique.
The injection site is found by placing the ultrasound probe under the clavicle in a parasagittal manner and counting from the second rib.
By moving the probe laterally towards the mid or posterior axillary line, the serratus anterior muscle is seen as a layer of muscle over the anechoic shadow of the rib.
It extends over the latissimus dorsi serratus anterior muscle and appears thicker and more prominent in the posterior axillary line.
30 mL of local anesthetic (bupivacaine) will be administered to the fascial plane by advancing the needle superficially or deeply into the serratus anterior muscle.
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30 minutes after induction
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Sham Comparator: Group K (Control group)
The patient, who was taken to the operating table with his consent, will be monitored.
ECG monitoring, SpO2 monitoring, invasive artery monitoring will be performed.
General Anesthesia will be applied(Induction with 2 mg/kg propofol, 0.6mg/kg rocuronium bromide, 2µcg/kg fentanyl, 2MAC sevoflurane + 40% air mixture and maintenance with 2L/min) Routine coronary artery bypass grafting surgery will be performed without any peripheral blocking and LIMA blood flow will be measured.
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30 minutes after induction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Blood flow
Time Frame: 30 minutes after induction
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LIMA blood flow will be measured
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30 minutes after induction
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Medicine School Department of Anesthesiology and Reanimation, Van Yuzuncu Yıl University
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)
January 2, 2023
Primary Completion (Actual)
June 2, 2024
Study Completion (Actual)
December 1, 2024
Study Registration Dates
First Submitted
May 23, 2023
First Submitted That Met QC Criteria
June 15, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 20, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2023-4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participants' personal information will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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