Effects of Erector Spinae Plane Block Method Used in Pain Management in Heart Surgery on Vascular Diameters

Not Applicable

Completed

• Conditions: Erector Spinae Plane Block; Bypass Extremity Graft; Coronary Artery Disease
• Interventions: Procedure: Erector Spinae Plane Block

• Registration Number: NCT04447560
• Lead Sponsor: Koç University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-25
• Study Start: 2020-07-06
• Primary Completion: 2020-09-28
• Study Completion: 2020-10-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Erector Spinae Plane Block	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.

Primary Outcome Measures

Name	Time	Method
Effect of erector spinae plane (ESP) block on the change in diameters of mammarian arteries and radial arteries	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of Mean Arterial Pressure on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block	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.	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 Pulse Oxymetri on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.	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.	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.
Measurement of Mean Heart Rate on basis, 5,10,15,20,25,30,35,40,45 minutes after the Erector Spinae Plane block.	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.	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.

Trial Locations

Locations (1)

Koc University; 🇹🇷 İstanbul, Turkey