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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05702125
Other study ID # IndonesiaUAnes921
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date March 31, 2024

Study information

Verified date January 2023
Source Indonesia University
Contact Ratna F Soenarto, Consultant
Phone 81310538988
Email fida.soenarto@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 96
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale Pain score to assess pain intensity 1 week after surgery
Primary Visual Analog Scale Pain score to assess postoperative pain intensity 3 months after surgery
Primary Visual Analog Scale Pain score to assess postoperative pain intensity 6 months after surgery
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