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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05282303
Other study ID # Cosarcan3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 10, 2020
Est. completion date January 20, 2021

Study information

Verified date March 2022
Source V.K.V. American Hospital, Istanbul
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background Pain after cardiac surgery is both multifocal and multifactorial. Sternotomy, sternal retraction, internal mammary dissection, posterior rib dislocation or fracture, possible brachial plexus injury, and mediastinal and pleural drains contribute to pain experienced in the immediate postoperative period. Ineffective pain management can cause systemic and pulmonary complications and significant cardiac consequences. Methods This study was conducted to compare the effectiveness of regional anesthesia techniques for perioperative pain management in cardiac surgery patients at our clinic. The effects of analgesic methods, in terms of contributing to recovery, have been examined.


Description:

This study was approved by the Koç University Clinical Research Ethics Committee (2021.464.IRB1.131); patients who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively. Patients with a history of cerebrovascular events, scheduled carotid surgery, or emergency CABG surgery were excluded from the study. Demographic data from the preoperative evaluation forms and operation types from the surgery reports were recorded. Intraoperative anesthesia follow-up forms were assessed if regional anesthesia was used, and the type and extent of opioids during the operation were examined. The postoperative transfer forms were examined to the cardiovascular intensive care unit (CICU), intensive care follow-up forms, and service ward record follow-up forms. Pain scores (NRS) during rest and coughing, vital signs, mobilization, and the start of respiratory exercises were recorded for postoperative respiratory complications.


Recruitment information / eligibility

Status Completed
Enrollment 221
Est. completion date January 20, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively Exclusion Criteria: - History of cerebrovascular event - History of Alzheimer's and dementia - Inadequate cognitive functions - History of chronic pain - Long-term opioid therapy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
CABG operation
Efficacy of regional analgesia techniques in coronary artery bypass operations

Locations

Country Name City State
Turkey American Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
V.K.V. American Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147. Review. — View Citation

Doehring A, Oertel BG, Sittl R, Lötsch J. Chronic opioid use is associated with increased DNA methylation correlating with increased clinical pain. Pain. 2013 Jan;154(1):15-23. doi: 10.1016/j.pain.2012.06.011. — View Citation

Elsharkawy H, Pawa A, Mariano ER. Interfascial Plane Blocks: Back to Basics. Reg Anesth Pain Med. 2018 May;43(4):341-346. doi: 10.1097/AAP.0000000000000750. Review. — View Citation

Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanc — View 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- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative analgesia NRS score 0 - 24 hours
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