- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04447560
Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters
January 11, 2021 updated by: Kamil Darcin, Koç University
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
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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İstanbul, Turkey, 34010
- Koç University
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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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who are aged between 18-75,
- ASA III
- Patients who are undergoing off pump coronary artery bypass grafting surgery
Exclusion Criteria:
- 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
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: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Erector Spinae Plane Block
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ömür Erçelen, Koç University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Smith 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.
- 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.
- Bourke 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.
- Nagaraja 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.
- Krishna 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. Erratum In: J Cardiothorac Vasc Anesth. 2022 Feb;36(2):627.
- Wink 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.
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)
July 6, 2020
Primary Completion (ACTUAL)
September 28, 2020
Study Completion (ACTUAL)
October 15, 2020
Study Registration Dates
First Submitted
June 1, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (ACTUAL)
June 25, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
Other Study ID Numbers
- ESPCVS01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
Starting from 6 months after publication for 5 years
IPD Sharing Access Criteria
No access criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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