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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Van, Turkey, 65100
        • Arzu Esen Tekeli

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: LIMA Blood flow
30 minutes after induction
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.
Procedure: LIMA Blood flow
30 minutes after induction
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.
Procedure: LIMA Blood flow
30 minutes after induction

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood flow
Time Frame: 30 minutes after induction
LIMA blood flow will be measured
30 minutes after induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yuzuncu Yıl University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Medicine School Department of Anesthesiology and Reanimation, Van Yüzüncü 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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