Coronary Artery DiseaseNCT04447560
Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters
A study testing Erector Spinae Plane Block in people with Coronary Artery Disease and Erector Spinae Plane Block, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
Off-pump coronary artery bypass grafting (OPCABG) is a bypass method performed on the working heart. Pain is a frequently seen side effect experienced following this surgery. Erector spinae plane block is our analgesia method that the investigators routinely perform prior to the surgery to overcome this problem. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Erector Spinae Plane Block, Bypass Extremity Graft
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2020to 15 Oct 2020
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are aged between 18-75,
- ASA III
- Patients who are undergoing off pump coronary artery bypass grafting surgery
Who cannot join
- Patients who are allergic to planned-medications,
- those with previous cardiac surgery,
- patients undergoing emergency surgery,
- uncontrolled diabetes mellitus,
- chronic opioid or opioid receptor agonist users,
- those with pre-operative neuropathies, psychiatric diseases,
- non-communicable patients and
- those who refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Erector Spinae Plane Block on Sympathectomy in Off Pump Coronary Artery Bypass Surgery
Off-pump coronary artery bypass grafting (OPCABG) is a bypass method performed on the working heart. Pain is a frequently seen side effect experienced following this surgery. Erector spinae plane block is our analgesia method that the investigators routinely perform prior to the surgery to overcome this problem. In this method, analgesic medication is given via a needle in between the two superficial muscle groups (erector spinae muscles) located in participants back. The investigators believe this method not only provides pain relief, but also is beneficial (dilating) on the vessels that will be used for bypassing the clogged vessels during the surgery. The investigators aimed to measure some parameters in this routine procedure before and after performing the analgesic method with an ultrasound (imaging with sound waves).
- Being tested
- Erector Spinae Plane Block
- Keywords
- Cardiac anesthesia, Sympathectomy, Off-pump coroner artery by-pass surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Also called Bupivacaine
One researcher will record the artery images as explained in the protocol and two researchers will measure the radius and area of those vessels separately. Researchers who are measuring the radius and area of vessels won't know whether those images belong to pre or post- ESP block. The results two researchers measure will be compared statistically and if there are no statistically significant differences, the mean value of their separate recordings will be taken into account for the statistical analysis.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Experimental | One researcher will record the artery images as explained in the protocol before and after the plane block and two researchers will measure the radius and area of those vessels separately. Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of erector spinae plane (ESP) block on the change in diameters of mammarian arteries and radial arteries
Linear probe is used for measurements. Images will be recorded by ultrasound from the third, fourth and fifth intercostal spaces for the LIMA and RIMA and 3cm proximal to the wrist for the right and left radial arteries. After images are saved, the researcher will perform ESP block with USG. Linear/convex probe is used to place the needle parasagittally 3 cm lateral to T5 spinous processes. ESP block will be performed to right and left sides equally with 40ml %0.25 bupivacaine in total, to the fascial plane between the transverse process and erector spinae muscle. Artery images will be recorded again by the same researcher after 45 minutes.For the recordings, one researcher will record the images as explained in the protocol and two researchers will measure the records separately. The results measured in millimeters by two researchers will be compared statistically and if there is no significant difference, the average value of the records will be used for statistical analysis.
Measured: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed in sitting position by an experienced anesthesiologist. Second measurement will be done 45 minutes after performing the ESP block
Secondary outcomes (3)
Measurement of Mean Arterial Pressure on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block
When each participant comes to the preoperative preparation room, the mean arterial pressure will be measured in mmHg. Then the erector spinae plane block will be performed. After the block is performed, a measurement will be recorded every 5 minutes. The last measurement will be done 45 minutes after the block is performed.
Measured: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.
Measurement of Mean Heart Rate on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
When each participant comes to the preoperative preparation room, the heart rate will be measured in per minute. Then the erector spinae plane block will be performed. After the block is performed, a measurement will be recorded every 5 minutes. The last measurement will be done 45 minutes after the block is performed.
Measured: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.
Measurement of Pulse Oxymetri on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
When each participant comes to the preoperative preparation room, the pulse oximetry will be measured. Then the erector spinae plane block will be performed. After the block is performed, a measurement will be recorded every 5 minutes. The last measurement will be done 45 minutes after the block is performed.
Measured: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start6 Jul 2020
- Primary completion28 Sep 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is planned as prospective. Aged between 18-75, ASA III risk group and are undergoing off pump coronary artery bypass grafting surgery are selected for the study. Who are allergic to planned-medications, chronic opioid or opioid receptor agonist users, those with preoperative neuropathies, psychiatric diseases will be excluded. Electrocardiography and pulse oximetry monitorization is performed in the recovery room where a peripheric intravenous line is opened afterwards. High frequency (12-24 MHz) linear probe is used for measurements. Images will be recorded by USG from the 3., 4. and 5. intercostal spaces for the LIMA and RIMA and 3cm proximal to the wrist for the right and left radial arteries. After images are saved, the researcher will perform ESP block with USG. ESP block will be performed to right and left sides equally with 40ml %0.25 bupivacaine in total. Artery images will be recorded again by the same researcher after 45 minutes.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Darcin, Koç University
- Investigators
- Ömür Erçelen, Study director, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447560
- Sponsor's protocol ID
- ESPCVS01
- Status last verified
- Jan 2021
- First submitted
- 1 Jun 2020
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Alvarez J, Hernandez B, Atanassoff PG. High thoracic epidural anesthesia and coronary artery disease in surgical and non-surgical patients. Curr Opin Anaesthesiol. 2005 Oct;18(5):501-6. doi: 10.1097/01.aco.0000183104.73931.22.
PubMed 16534283Bourke T, Vaseghi M, Michowitz Y, Sankhla V, Shah M, Swapna N, Boyle NG, Mahajan A, Narasimhan C, Lokhandwala Y, Shivkumar K. Neuraxial modulation for refractory ventricular arrhythmias: value of thoracic epidural anesthesia and surgical left cardiac sympathetic denervation. Circulation. 2010 Jun 1;121(21):2255-62. doi: 10.1161/CIRCULATIONAHA.109.929703. Epub 2010 May 17.
PubMed 20479150Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
PubMed 30052229Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
PubMed 30055991Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818.
PubMed 31833864Wink J, Veering BT, Aarts LPHJ, Wouters PF. Effects of Thoracic Epidural Anesthesia on Neuronal Cardiac Regulation and Cardiac Function. Anesthesiology. 2019 Mar;130(3):472-491. doi: 10.1097/ALN.0000000000002558.
PubMed 30676423
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erector Spinae Plane Block on Sympathectomy in Off Pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT04447560
- Acronym / sponsor ID
- ESPCVS01
- Keywords
- Cardiac anesthesia, Sympathectomy, Off-pump coroner artery by-pass surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 28 Sep 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 25 Jun 2020 (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.
Off-pump coronary artery bypass grafting (OPCABG) is a bypass method performed on the working heart. Pain is a frequently seen side effect experienced following this surgery. Erector spinae plane block is our analgesia method that the investigators routinely perform prior to the surgery to overcome this problem. In this method, analgesic medication is given via a needle in between the two superficial muscle groups (erector spinae muscles) located in participants back. The investigators believe this method not only provides pain relief, but also is beneficial (dilating) on the vessels that will be used for bypassing the clogged vessels during the surgery. The investigators aimed to measure some parameters in this routine procedure before and after performing the analgesic method with an ultrasound (imaging with sound waves).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is planned as prospective. Aged between 18-75, ASA III risk group and are undergoing off pump coronary artery bypass grafting surgery are selected for the study. Who are allergic to planned-medications, chronic opioid or opioid receptor agonist users, those with preoperative neuropathies, psychiatric diseases will be excluded. Electrocardiography and pulse oximetry monitorization is performed in the recovery room where a peripheric intravenous line is opened afterwards. High frequency (12-24 MHz) linear probe is used for measurements. Images will be recorded by USG from the 3., 4. and 5. intercostal spaces for the LIMA and RIMA and 3cm proximal to the wrist for the right and left radial arteries. After images are saved, the researcher will perform ESP block with USG. ESP block will be performed to right and left sides equally with 40ml %0.25 bupivacaine in total. Artery images will be recorded again by the same researcher after 45 minutes.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockOne researcher will record the artery images as explained in the protocol before and after the plane block and two researchers will measure the radius and area of those vessels separately. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are aged between 18-75,
- ASA III
- Patients who are undergoing off pump coronary artery bypass grafting surgery
Key exclusion criteria (8 listed)
- Patients who are allergic to planned-medications,
- those with previous cardiac surgery,
- patients undergoing emergency surgery,
- uncontrolled diabetes mellitus,
- chronic opioid or opioid receptor agonist users,
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 |
|---|---|---|
| Erector Spinae Plane BlockAlso: BupivacaineOne researcher will record the artery images as explained in the protocol and two researchers will measure the radius and area of those vessels separately. Researchers who are measuring the radius and area of vessels won't know whether those images belong to pre or post- ESP block. The results two researchers measure will be compared statistically and if there are no statistically significant differences, the mean value of their separate recordings will be taken into account for the statistical analysis. | Procedure or surgery | Erector Spinae Plane Block |
Primary outcome
Effect of erector spinae plane (ESP) block on the change in diameters of mammarian arteries and radial arteries
Time frame: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed in sitting position by an experienced anesthesiologist. Second measurement will be done 45 minutes after performing the ESP block
Linear probe is used for measurements. Images will be recorded by ultrasound from the third, fourth and fifth intercostal spaces for the LIMA and RIMA and 3cm proximal to the wrist for the right and left radial arteries. After images are saved, the researcher will perform ESP block with USG. Linear/convex probe is used to place the needle parasagittally 3 cm lateral to T5 spinous processes. ESP block will be performed to right and left sides equally with 40ml %0.25 bupivacaine in total, to the fascial plane between the transverse process and erector spinae muscle. Artery images will be recorded again by the same researcher after 45 minutes.For the recordings, one researcher will record the images as explained in the protocol and two researchers will measure the records separately. The results measured in millimeters by two researchers will be compared statistically and if there is no significant difference, the average value of the records will be used for statistical analysis.
3 secondary outcomes
Measurement of Mean Arterial Pressure on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block
Time frame: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.
Measurement of Mean Heart Rate on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
Time frame: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.
Measurement of Pulse Oxymetri on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
Time frame: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed. After the block, a measurement will be made every 5 minutes. The last measurement will be made 45 minutes after the block.
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 13 Jan 2021.
- Background: PubMed 16534283Alvarez J, Hernandez B, Atanassoff PG. High thoracic epidural anesthesia and coronary artery disease in surgical and non-surgical patients. Curr Opin Anaesthesiol. 2005 Oct;18(5):501-6. doi: 10.1097/01.aco.0000183104.73931.22.
- Background: PubMed 20479150Bourke T, Vaseghi M, Michowitz Y, Sankhla V, Shah M, Swapna N, Boyle NG, Mahajan A, Narasimhan C, Lokhandwala Y, Shivkumar K. Neuraxial modulation for refractory ventricular arrhythmias: value of thoracic epidural anesthesia and surgical left cardiac sympathetic denervation. Circulation. 2010 Jun 1;121(21):2255-62. doi: 10.1161/CIRCULATIONAHA.109.929703. Epub 2010 May 17.
- Background: PubMed 30052229Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
- Background: PubMed 30055991Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
- Background: PubMed 31833864Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818.
- Results publication: PubMed 30676423Wink J, Veering BT, Aarts LPHJ, Wouters PF. Effects of Thoracic Epidural Anesthesia on Neuronal Cardiac Regulation and Cardiac Function. Anesthesiology. 2019 Mar;130(3):472-491. doi: 10.1097/ALN.0000000000002558.
- Individual participant dataSharing planned: Yes
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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.
Ömür Erçelen study director
Koç 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 Erector Spinae Plane Block in people with Coronary Artery Disease and Erector Spinae Plane Block, run by Koç 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 3 inclusion and 8 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 13 Jan 2021. 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. 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?
Effect of erector spinae plane (ESP) block on the change in diameters of mammarian arteries and radial arteries (time frame: The first measurement will be done in the pre-operative preparation room for each participant, and block will be performed in sitting position by an experienced anesthesiologist. Second measurement will be done 45 minutes after performing the ESP block). 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 NCT04447560, which also lists 6 linked publications.
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 13 Jan 2021.