Effect of Stellate Ganglion Block on Internal Mammary Artery Dynamics

May 31, 2025 updated by: Diaaeldin Badr Aboelnile, Ain Shams University
This study aims to assess the effect of a stellate ganglion block on the flow and diameter of the internal mammary artery using the pulsatility index and transient time flowmetry(TTFM) in patients undergoing coronary artery bypass grafting.

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

The internal mammary artery (IMA) is the preferred graft for myocardial revascularization because of its superiority over venous grafts owing to long term patency, lower mortality rates and improved post-operative outcomes.

However, conduit spasm is a recognized complication of coronary artery bypass surgery mainly affecting the arterial conduits, a major concern that can lead to acute myocardial ischemia and may contribute to reduce graft patency.

Topical application or systemic administration of many pharmacological agents has been shown to reverse or prevent graft spasm, but side effects are reported with the use of these agents.

Various vasodilators that have been tried included various organic nitrates, calcium channel blockers, sodium nitroprusside (SNP) and papaverine.

Over the last few years, there were some studies, which investigated the effect of regional anesthesia techniques such as thoracic epidural anesthesia (TEA) and stellate ganglion block (SGB) for sympatholysis and studied its effects on internal mammary artery diameter .

The stellate ganglion block with local anesthetics have been widely used to provide pain relief to treat vascular spastic disorders of upper limbs, chronic pain conditions and treatment of refractory angina.

The stellate ganglion block has also been used for increasing radial artery (RA) blood flow and preventing RA spasm by sympathetic blockade in coronary artery bypass surgery.

In our study, two groups will be compared regarding IMA blood flow and diameter. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block during both the preoperative and intraoperative periods in both groups. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow. Additionally, topical nitroglycerin will be applied intraoperatively in both groups, regardless of whether they received the stellate ganglion block.

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.
70

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.
  • Name: Diaaeldin DA Aboelnile, MD, Lecturer
  • Phone Number: 201018380033
  • Email: diaabadr@gmail.com

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11588
        • Ain Shams University Hospitals

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

No

Description

Inclusion Criteria:

  • Age: 18 to 65 years.
  • Patients who will be slated to undergo elective coronary artery bypass graft surgery under Cardiopulmonary bypass in the Department of Cardiothoracic Surgery.

Exclusion Criteria:

  • Patient not willing to participate in the study.
  • Age more than 65 years.
  • Ejection fraction < 45%.
  • History of strokes / Transient ischaemic attacks and vertebro basilar insufficiency
  • History of Glaucoma.
  • History of allergy to local anaesthetic drugs.
  • Emergency coronary artery bypass graft or reoperations.
  • Pre-existing contralateral phrenic nerve palsy.
  • Patients with existing coagulopathy.
  • Allergy to nitroglycerin.

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: Treatment
  • 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.
Experimental: The first group (A) Stellate Ganglion Block Group
Participants in this group will receive a left stellate ganglion block (LSGB) preoperatively. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block and during both the preoperative and the intraoperative periods. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow.
Procedure: Left stellate ganglion block
patients will be positioned with head in midline position and mild extension of the neck. Cricoid cartilage will be identified by midline palpation of the neck and a 12 mega hertz ultrasound probe will be used. The airway will be identified by the shadow of the cricoid cartilage at the level of C6 vertebrae. The probe will be moved laterally to identify internal jugular vein, carotid artery and thyroid. Depth of ultrasound field will be adjusted to include the transverse process of the C6 vertebra. Following complete aseptic precautions, an echogenic insulated needle 5 cm long will be inserted under ultrasound guidance and directed toward the transverse process of the C6 vertebra. After the needle tip will make contact with the transverse process, it will be withdrawn 2 mm and 8 ml of 0.25% bupivacaine will be injected.
Drug: Topical Nitroglycerine
Application of topical Nitroglycerin solution to the LIMA pedicle graft during dissection of the vessel in both study arms.
Active Comparator: The second Group (B) Control Group (No left stellate ganglion block LSGB)
Participants in this group will not receive a stellate ganglion block. The IMA pulsatility index and diameter will be measured before and after the stellate ganglion block and during both the preoperative and the intraoperative periods. Transit-time flowmetry (TTFM) will be used intraoperatively to assess IMA flow. Topical nitroglycerin will also be applied intraoperatively, similar to the SGB group.
Drug: Topical Nitroglycerine
Application of topical Nitroglycerin solution to the LIMA pedicle graft during dissection of the vessel in both study arms.

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
Effect of left stellate ganglion block on the left internal mammary artery blood flow after 10 minutes
Time Frame: 10 minutes after the left Stellate Ganglion Block
LIMA blood flow will be measured using the pulsatility index
10 minutes after the left Stellate Ganglion Block

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Left Internal Mammary Artery (LIMA) diameter after left Stellate Ganglion Block
Time Frame: 10 minutes after block
LIMA diameter measurement using ultrasound
10 minutes after block
Effect of left stellate ganglion block on the left internal mammary artery blood flow after cardiopulmonary bypass
Time Frame: After cardiopulmonary bypass
Measurement of LIMA blood flow using transit time flow measurement.
After cardiopulmonary bypass
Effect of left stellate ganglion block on mean blood pressure (MBP)
Time Frame: During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation
Effect of the block on hemodynamics
During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation
Effect of left stellate ganglion block on heart rate (HR))
Time Frame: During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation
Effect of the block on hemodynamics
During surgery: baseline, after induction of anesthesia, at time after skin incision, after sternotomy, before and after cardiopulmonary bypass (CPB), after protamine and at the end of operation

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.
Ain Shams 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.
  • Principal Investigator: Diaaeldin DA Aboelnile, MD, Lecturer, Faculty of Medicine, Ain Shams 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.
August 8, 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.
February 10, 2025

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.
February 10, 2025

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).
July 11, 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.
July 18, 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.
July 19, 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.
June 3, 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.
May 31, 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.
May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • FMASU MD124/2023

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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