REGIONAL ANALGESIA TECHNIQUES FOR EFFECTIVE RECOVERY TO C... | NCT05282303

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2020Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jan 20, 2021Actual

First Submitted Date

Feb 25, 2022

First Submission Date that Met QC Criteria

Mar 7, 2022

First Posted Date

Mar 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2022

Last Update Posted Date

Mar 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sami Kaan Coşarcan, MD, V.K.V. American Hospital, IstanbulPrincipal Investigator

Lead Sponsor

V.K.V. American Hospital, IstanbulOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

221Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CABG operation	Procedure	Efficacy of regional analgesia techniques in coronary artery bypass operations	DIESPB PIB SAB TPVB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative analgesia	NRS score	0 - 24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with coronary artery disease scheduled for bypass surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
American Hospital		Istanbul		34365	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25500688	Result	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.
23273101	Result	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.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms