Chest Wall BlocksNCT05907798
Serratus Anterior Plan Block (SAP) and Pectoralis (PECSI-II) Blocks on Left Internal Mammarian Artery (LIMA) Blood Flow
A study testing LIMA Blood flow in people with Chest Wall Blocks, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Wall Blocks
- What is being tested?
- LIMA Blood flow
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Agreeing to participate in the study
- 20-65 years old
- ASA I-II-III
- Coronary artery bypass grafting will be performed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chest Wall Blocks
- Being tested
- LIMA Blood flow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIMA Blood flowProcedure or surgery
30 minutes after induction
| Study group | Role | What they receive |
|---|---|---|
| Group PECS | Active comparator | 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. Receives: Procedure: LIMA Blood flow |
| Group SA | Active comparator | 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. Receives: Procedure: LIMA Blood flow |
| Group K (Control group) | Sham comparator | 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. Receives: Procedure: LIMA Blood flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
LIMA blood flow will be measured
Measured: 30 minutes after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start2 Jan 2023
- Primary completion2 Jun 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest Wall BlocksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blind, method comparison study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- Medicine School Department of Anesthesiology and Reanimation, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907798
- Sponsor's protocol ID
- 2023-4
- Status last verified
- Jan 2025
- First submitted
- 23 May 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants' personal information will not be shared.
Publications
Tekeli AE, Eker E, Sahinalp S, Yuzkat N, Caliskan R, Catulay D, Uzlas M, Elkassabany N. Association of pectoral nerve (PECS) and Serratus Anterior Plane (SAP) blocks with intraoperative left internal mammary artery free blood flow and hemodynamic responses in patients undergoing coronary artery bypass grafting: a randomized controlled trial. BMC Anesthesiol. 2026 Jun 2. doi: 10.1186/s12871-026-03974-x. Online ahead of print.
PubMed 42231185
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05907798
- Acronym / sponsor ID
- 2023-4
- Conditions
- Chest Wall Blocks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 2 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, single-blind, method comparison study
| Arm | Type | Receives |
|---|---|---|
| Group PECS | Active comparator | Procedure: LIMA Blood flowplacing 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. |
| Group SA | Active comparator | Procedure: LIMA Blood flowIt 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. |
| Group K (Control group) | Sham comparator | Procedure: LIMA Blood flowThe 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Agreeing to participate in the study
- 20-65 years old
- ASA I-II-III
- Coronary artery bypass grafting will be performed
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIMA Blood flow30 minutes after induction | Procedure or surgery | Group K (Control group), Group PECS, Group SA |
Primary outcome
Blood flow
Time frame: 30 minutes after induction
LIMA blood flow will be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 42231185Tekeli AE, Eker E, Sahinalp S, Yuzkat N, Caliskan R, Catulay D, Uzlas M, Elkassabany N. Association of pectoral nerve (PECS) and Serratus Anterior Plane (SAP) blocks with intraoperative left internal mammary artery free blood flow and hemodynamic responses in patients undergoing coronary artery bypass grafting: a randomized controlled trial. BMC Anesthesiol. 2026 Jun 2. doi: 10.1186/s12871-026-03974-x. Online ahead of print.
- Individual participant dataSharing planned: No. Participants' personal information will not be shared.
Related trials for Chest Wall Blocks
Recruiting
Preoperative Deep Parasternal Intercostal Plane Block and Intraoperative Opioid Use in Cardiac Surgery
Postoperative Pain, Sternotomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medicine School Department of Anesthesiology and Reanimation study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIMA Blood flow in people with Chest Wall Blocks, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood flow (time frame: 30 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.