Viewing Study NCT04928521



Ignite Creation Date: 2024-05-06 @ 4:15 PM
Last Modification Date: 2024-10-26 @ 2:07 PM
Study NCT ID: NCT04928521
Status: COMPLETED
Last Update Posted: 2021-12-28
First Post: 2021-06-06

Brief Title: Erector Spinae Plane ESP Block With 20 ml Versus 30 ml in Cardiac Surgery
Sponsor: Ankara City Hospital Bilkent
Organization: Ankara City Hospital Bilkent

Study Overview

Official Title: Comparison of Postoperative Analgesic Efficacy of Erector Spinae Plane Block With 20 ml and 30 ml Bupivacaine Volumes in Cardiac Surgery
Status: COMPLETED
Status Verified Date: 2021-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Even though erector spinae plane ESP block is shown to be efficient in cardiac surgery it is still controversial how much volume is necessary for efficient analgesic effect for sternotomy and drain tube pain relief This study aims to investigate the optimal local anesthetic volume 20 mL versus 30 mL with ESP block for open-heart cardiac surgery
Detailed Description: In cardiac surgery the most common cause of pain during the first two days postoperatively is median sternotomy In a study in which 705 patients who had undergone cardiac surgery were followed up prospectively postoperative 24 hours pain scores ranging from 53 to 65 out of 10 with deep breathing and coughing were shown In these patients it may increase the frequency of atelectasis due to reasons such as failure in pain control weak coughing and limitation of movement and these may lead increase in morbidity and hospital stay Although nonsteroidal analgesics and opioids are used successfully in the control of this severe pain they are far from being ideal analgesics alone due to their side effects such as kidney damage bleeding risk sedation respiratory depression itching nausea and vomiting The complications of neuraxial techniques seem to be the disadvantages of these methods Erector spinae plane ESP block is one of the regional anesthesia techniques that has been shown to be effective in reducing sternotomy pain in sternotomy-guided cardiac surgeries

The Erector spinae plane ESP block was first described by Forero in 2016 In this block technique a local anesthetic is given to the plane between the erector spinae muscle and the vertebral transverse process The dorsal and ventral branches of the spinal nerves are blocked in this plane However due to individual regional anatomical differences there is not enough data to determine the optimum volume at which the appropriate spread of local anesthetic will occur Volume-based cadaver studies have some handicaps since they do not have the characteristics of living tissue

This study aims to compare the postoperative analgesic efficacy of ESP block applied at the same dose but with different local anesthetic volumes in cardiac surgeries to be performed with sternotomy

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None