Back to resultsEffects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters
Primary Purpose
Coronary Artery Disease, Erector Spinae Plane Block, Bypass Extremity Graft
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Cardiac anesthesia, Sympathectomy, Off-pump coroner artery by-pass surgery
Eligibility Criteria
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
Sites / Locations
- Koc University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erector Spinae Plane Block
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04447560
Brief Title
Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters
Official Title
Effects of Erector Spinae Plane Block on Sympathectomy in Off Pump Coronary Artery Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
September 28, 2020 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Koç University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Erector Spinae Plane Block, Bypass Extremity Graft
Keywords
Cardiac anesthesia, Sympathectomy, Off-pump coroner artery by-pass surgery
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erector Spinae Plane Block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Other Intervention Name(s)
Bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of erector spinae plane (ESP) block on the change in diameters of mammarian arteries and radial arteries
Description
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.
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
Secondary Outcome Measure Information:
Title
Measurement of Mean Arterial Pressure on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block
Description
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.
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.
Title
Measurement of Mean Heart Rate on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
Description
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.
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.
Title
Measurement of Pulse Oxymetri on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ömür Erçelen
Organizational Affiliation
Koç University
Official's Role
Study Director
Facility Information:
Facility Name
Koc University
City
İstanbul
ZIP/Postal Code
34010
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Starting from 6 months after publication for 5 years
IPD Sharing Access Criteria
No access criteria
Citations:
PubMed Identifier
16534283
Citation
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.
Results Reference
background
PubMed Identifier
20479150
Citation
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.
Results Reference
background
PubMed Identifier
30052229
Citation
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.
Results Reference
background
PubMed Identifier
30055991
Citation
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.
Results Reference
background
PubMed Identifier
31833864
Citation
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.
Results Reference
background
PubMed Identifier
30676423
Citation
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.
Results Reference
result
Learn more about this trial
Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters
We'll reach out to this number within 24 hrs