Clinical trial NCT04447560: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Erector Spinae Plane Block
Bypass Extremity Graft
Keywords: Cardiac anesthesia
Sympathectomy
Off-pump coroner artery by-pass surgery
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Effect of erector spinae plane (ESP) block on the change in diameters of mammarian arteries and radial arteries
timeFrame: 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:
measure: Measurement of Mean Arterial Pressure on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block
timeFrame: 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.
measure: Measurement of Mean Heart Rate on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
timeFrame: 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.
measure: Measurement of Pulse Oxymetri on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.
timeFrame: 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.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Ömür Erçelen
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.