NCT05282303

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

6 months

First QC Date

February 25, 2022

Last Update Submit

March 7, 2022

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia

    NRS score

    0 - 24 hours

Study Arms (4)

DIESPB

Dual injection of erector spinae plane block

Procedure: CABG operation

TPVB

Thoracic paravertebral block

Procedure: CABG operation

SAB

Serratus anterior plane block

Procedure: CABG operation

PIB

Parasternal ıntercostal block

Procedure: CABG operation

Interventions

CABG operationPROCEDURE

Efficacy of regional analgesia techniques in coronary artery bypass operations

DIESPBPIBSABTPVB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with coronary artery disease scheduled for bypass surgery

You may qualify if:

  • Who underwent coronary artery bypass grafting (CABG) surgery at the VKV American Hospital between January 2015 and May 2020 were reviewed retrospectively

You may not qualify if:

  • History of cerebrovascular event
  • History of Alzheimer's and dementia
  • Inadequate cognitive functions
  • History of chronic pain
  • Long-term opioid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Hospital

Istanbul, 34365, Turkey (Türkiye)

Location

Related 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.

    PMID: 25500688RESULT

  • Doehring A, Oertel BG, Sittl R, Lotsch 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.

    PMID: 23273101RESULT

  • 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.

    PMID: 30052229RESULT

  • 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: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.

    PMID: 31054241RESULT

  • 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.

    PMID: 29561295RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 16, 2022

Study Start

July 10, 2020

Primary Completion

January 1, 2021

Study Completion

January 20, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations

TU(1)