Chronic Pain After Cardiothoracic Surgery

January 26, 2023 updated by: Ratna Farida Soenarto, Indonesia University
This is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Ratna F Soenarto, Consultant, Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes921

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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