Chronic PainNCT05702125
Chronic Pain After Cardiothoracic Surgery
An observational study of Chronic Pain and Thoracic, run by Universitas Indonesia.
Trial summary
This is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Thoracic, Chronic Pain Syndrome
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergo elective sternotomy and/or thoracotomy using general anesthesia in Cipto Mangunkusumo hospital during January 2023 until March 2024
Who may be able to join
- Patients undergo elective sternotomy and/or thoracotomy using general anesthesia
- Patients agree to follow the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
This is a prospective cohort study to estimate prevalence of chronic pain after cardiothoracic surgery
Read the 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.
- Conditions
- Chronic Pain, Thoracic, Chronic Pain Syndrome
- Keywords
- chronic pain, thoracotomy, sternotomy, cardiothoracic surgery
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain score to assess pain intensity
Measured: 1 week after surgery
Visual Analog Scale
Pain score to assess postoperative pain intensity
Measured: 3 months after surgery
Visual Analog Scale
Pain score to assess postoperative pain intensity
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ratna Farida Soenarto, Universitas Indonesia
- Investigators
- Ratna F Soenarto, Consultant, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702125
- Sponsor's protocol ID
- IndonesiaUAnes921
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT05702125
- Acronym / sponsor ID
- IndonesiaUAnes921
- Conditions
- Chronic Pain, Thoracic, Chronic Pain Syndrome
- Keywords
- chronic pain, thoracotomy, sternotomy, cardiothoracic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergo elective sternotomy and/or thoracotomy using general anesthesia in Cipto Mangunkusumo hospital during January 2023 until March 2024
Key inclusion criteria (2 listed)
- Patients undergo elective sternotomy and/or thoracotomy using general anesthesia
- Patients agree to follow the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale
Time frame: 1 week after surgery
Pain score to assess pain intensity
Visual Analog Scale
Time frame: 3 months after surgery
Pain score to assess postoperative pain intensity
Visual Analog Scale
Time frame: 6 months after surgery
Pain score to assess postoperative pain intensity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratna F Soenarto, Consultant principal investigator
Universitas Indonesia
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Thoracic, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ratna F Soenarto, Consultant (81310538988 ext. +62, fida.soenarto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 1 week after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.