Chronic Pain After Cardiothoracic Surgery | NCT05702125

Studies
Chronic Pain After Cardiothoracic Surgery

NCT05702125

Sponsor

Indonesia University

Status

Unknown status

Last Update Posted

Jan 27, 2023Actual

Enrollment

96Estimated

Phase

Not provided

Conditions

Chronic Pain
Thoracic
Chronic Pain Syndrome

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Estimated

Primary Completion Date

Mar 31, 2024Estimated

Completion Date

Mar 31, 2024Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 26, 2023

First Posted Date

Jan 27, 2023Actual

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

Jan 26, 2023

Last Update Posted Date

Jan 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery

Detailed Description

This is a prospective cohort study of all patients undergo cardiothoracic elective surgery in Cipto Mangunkusumo Hospital using general anesthesia. Patients with emergency surgery, history of psychologic and neurologic disease which cannot reliably state their pain score, cannot communicate well, and disagree to follow the research will be exempted. The pain score will be recorded one week after surgery during walk-in consultation, followed by 3 months and 6 months after surgery via telecommunication.

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

96Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analog Scale	Pain score to assess pain intensity	1 week after surgery
Visual Analog Scale	Pain score to assess postoperative pain intensity	3 months after surgery
Visual Analog Scale	Pain score to assess postoperative pain intensity	6 months after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergo elective sternotomy and/or thoracotomy using general anesthesia
Patients agree to follow the study

Exclusion Criteria:

Patients undergo emergency sternotomy or thoracotomy
Patients with pyschological and neurological disorder, that it is not reliable to determine the pain intensity
Patients who cannot communicate
Patients disagree to follow the study

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 undergo elective sternotomy and/or thoracotomy using general anesthesia in Cipto Mangunkusumo hospital during January 2023 until March 2024

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ratna F Soenarto, Consultant	Contact	81310538988	+62	fida.soenarto@gmail.com

Overall Officials

Name	Affiliation	Role
Ratna F Soenarto, Consultant	Indonesia University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided