Cardiac SurgeryNCT06534372
Affecting Factors for Chronic Pain After Sternotomy
An observational study of Cardiac Surgery and Sternotomy, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Chronic pain is common complication of surgery procedures. Rates of mortalits is getting lower in cardiac surgery. This situation has brought us to focus morbidity and long term life quality. Previous study show that chronic pain after cardiac surgery is experienced 11-40% patient. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Sternotomy, Pain, Acute
- What is being tested?
- Open cardiac surgery with sternotomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the ASA I-II-III risk group, between the ages of 18-80 years, with a BMI between 18-35 kg/m2, who will undergo elective open coronary artery bypass graft surgery, who will undergo elective open heart valve surgery, who will undergo general anesthesia, and who will undergo sternotomy will be included in the study.
Who may be able to join
- Between the ages of 18-80
- BMI 18-35 kg/m2
- ASA (American Society of Anesthesiologists) Scoring I-II-III
- Elective open coronary artery bypass graft surgery
- Elective open heart valve surgery
- Patients who will undergo general anesthesia
- Patients who agree to participate in the study and sign a form
Who cannot join
- Patients under 18 and over 80 years of age
- Patients who do not want to participate in the study
- Patients with advanced organ failure (liver failure, renal failure)
- Patients with chronic pain or chronic opioid use
- Patients with alcohol, substance or drug addiction
- Patients planned for surgery with thoracotomy
Show all 10Show fewer
- Patients with a history of previous sternotomy (redo)
- Patients with limited cooperation such as dementia, psychiatric disorders
- Pregnant and breastfeeding patients will be excluded from the study.
- Patients who cannot communicate in their native language will be excluded from the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Ankara Etlik City Hospital
Ankara, Ankara, 06290
Umut Can Özağar, M.D., 00905546271611, ozagarumutcan@hotmail.com
Julide Ergil, Professor, 00905323469216, julideergil@hotmail.com
- Recruiting
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010
Jülide Ergil, +903127970000 ext. 123129, julideergil@hotmail.com
Umut Can Özağar
About this study
Official title: Affecting Factors the Incidince of Chronic Pain After Sternotomy
Chronic pain is common complication of surgery procedures. Rates of mortalits is getting lower in cardiac surgery. This situation has brought us to focus morbidity and long term life quality. Previous study show that chronic pain after cardiac surgery is experienced 11-40% patient. Multifactorial causes play a role in chronic pain etiology. The aim of our study is to determine the causes of chronic pain in patients who underwent sternotomy.
Read the detailed description
Pain can be classified as anatomical, etiological, duration, intensity, and pathophysiological.
Classification according to duration is made according to the duration that the person feels the pain. Here, the classification is basically divided into acute and chronic. Acute pain is usually associated with acute injury or trauma. Chronic pain is defined as pain that continues after the expected period for the tissues to heal. Chronic pain is pain that lasts for 3 months or longer. Various conditions, usually including psychological and ethnic conditions, can affect the type of pain.
More than 2 million people worldwide undergo open heart surgery. Although mortality rates have decreased significantly thanks to advances in anesthesia and surgery, chronic pain after open heart surgery is still a serious problem. The rate of chronic pain varies between 11-40% within 1 year after cardiac surgery. Since open heart surgery is a very common procedure, it affects many people. Therefore; It is important to understand the factors related to the development of chronic pain.
Many risk factors have been identified for chronic pain after coronary artery bypass surgery. These are; female gender, young age, preoperative anxiety, intraoperative opioid use, and intense pain in the first days of the postoperative period. Although there are various retrospective and prospective studies on this subject, these studies are still insufficient and need support in the literature.
In this study, investigators aim to reveal the factors that increase chronic pain after sternotomy, take precautions against these factors and reduce the development of chronic pain.
Chronic pain is a problem that has been increasing in our country as well as all over the world in recent years. Therefore, defining the factors related to pain is very important. In our study, investigators aim to reveal the factors that increase chronic pain after sternotomy. By determining these factors, it will be possible to prevent the development of chronic pain in patients, reduce costs and increase the quality of life of patients. This study does not pose any risk for the patients to be included.
- Conditions
- Cardiac Surgery, Sternotomy, Pain, Acute, Pain, Chronic
- Being tested
- Open cardiac surgery with sternotomy
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open cardiac surgery with sternotomyProcedure or surgery
Factors affecting the occurrence of chronic pain in patients undergoing open cardiac surgery with sternotomy will be investigated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
Patients' self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain.
Measured: 3rd postoperative month
Secondary outcomes (4)
Self-leeds assessment of neuropathic symptoms and sign findings at 6th months
Patients' self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain.
Measured: 6th postoperative month
Short Form 12 scores in the 3rd month.
Short Form 12 scores will be evaluated in the 3rd month to evaluate the quality of life of the patients.
Measured: 3rd postoperative month
Short Form 12 scores in the 6th month.
Short Form 12 scores will be evaluated in the 6th month to evaluate the quality of life of the patients.
Measured: 6th postoperative month
Acute pain score
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be made in 1, 2, 12, 24 hour after extubation in the postoperative period.
Measured: Up to postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Sep 2024
- Primary completion10 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Umut Can Özağar, Ankara Etlik City Hospital
- Investigators
- Jülide Ergil, Professor, Study director, WHO, Turkish Society of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534372
- Sponsor's protocol ID
- AEŞH-EK1-2024-0068
- Status last verified
- Jan 2025
- First submitted
- 30 Jul 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affecting Factors the Incidince of Chronic Pain After Sternotomy
- ClinicalTrials.gov ID
- NCT06534372
- Acronym / sponsor ID
- AEŞH-EK1-2024-0068
- Conditions
- Cardiac Surgery, Sternotomy, Pain, Acute, Pain, Chronic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 2 Aug 2024 (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.
Chronic pain is common complication of surgery procedures. Rates of mortalits is getting lower in cardiac surgery. This situation has brought us to focus morbidity and long term life quality. Previous study show that chronic pain after cardiac surgery is experienced 11-40% patient. Multifactorial causes play a role in chronic pain etiology. The aim of our study is to determine the causes of chronic pain in patients who underwent sternotomy.
Detailed description
Pain can be classified as anatomical, etiological, duration, intensity, and pathophysiological.
Classification according to duration is made according to the duration that the person feels the pain. Here, the classification is basically divided into acute and chronic. Acute pain is usually associated with acute injury or trauma. Chronic pain is defined as pain that continues after the expected period for the tissues to heal. Chronic pain is pain that lasts for 3 months or longer. Various conditions, usually including psychological and ethnic conditions, can affect the type of pain.
More than 2 million people worldwide undergo open heart surgery. Although mortality rates have decreased significantly thanks to advances in anesthesia and surgery, chronic pain after open heart surgery is still a serious problem. The rate of chronic pain varies between 11-40% within 1 year after cardiac surgery. Since open heart surgery is a very common procedure, it affects many people. Therefore; It is important to understand the factors related to the development of chronic pain.
Many risk factors have been identified for chronic pain after coronary artery bypass surgery. These are; female gender, young age, preoperative anxiety, intraoperative opioid use, and intense pain in the first days of the postoperative period. Although there are various retrospective and prospective studies on this subject, these studies are still insufficient and need support in the literature.
In this study, investigators aim to reveal the factors that increase chronic pain after sternotomy, take precautions against these factors and reduce the development of chronic pain.
Chronic pain is a problem that has been increasing in our country as well as all over the world in recent years. Therefore, defining the factors related to pain is very important. In our study, investigators aim to reveal the factors that increase chronic pain after sternotomy. By determining these factors, it will be possible to prevent the development of chronic pain in patients, reduce costs and increase the quality of life of patients. This study does not pose any risk for the patients to be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the ASA I-II-III risk group, between the ages of 18-80 years, with a BMI between 18-35 kg/m2, who will undergo elective open coronary artery bypass graft surgery, who will undergo elective open heart valve surgery, who will undergo general anesthesia, and who will undergo sternotomy will be included in the study.
Key inclusion criteria (7 listed)
- Between the ages of 18-80
- BMI 18-35 kg/m2
- ASA (American Society of Anesthesiologists) Scoring I-II-III
- Elective open coronary artery bypass graft surgery
- Elective open heart valve surgery
Key exclusion criteria (10 listed)
- Patients under 18 and over 80 years of age
- Patients who do not want to participate in the study
- Patients with advanced organ failure (liver failure, renal failure)
- Patients with chronic pain or chronic opioid use
- Patients with alcohol, substance or drug addiction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open cardiac surgery with sternotomyFactors affecting the occurrence of chronic pain in patients undergoing open cardiac surgery with sternotomy will be investigated. | Procedure or surgery | – |
Primary outcome
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
Time frame: 3rd postoperative month
Patients' self-Leeds assessment of neuropathic symptoms and sign (S-LANSS) findings will be evaluated in the 3rd postoperative month. Patients with an S-LANSS score of 12 and above will be diagnosed with chronic neuropathic pain.
4 secondary outcomes
Self-leeds assessment of neuropathic symptoms and sign findings at 6th months
Time frame: 6th postoperative month
Short Form 12 scores in the 3rd month.
Time frame: 3rd postoperative month
Short Form 12 scores in the 6th month.
Time frame: 6th postoperative month
Acute pain score
Time frame: Up to postoperative 24 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Jülide Ergil, Professor study director
WHO, Turkish Society of Anesthesiology and Reanimation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Sternotomy, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Umut Can Özağar, M.D. (00905546271611, ozagarumutcan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months. (time frame: 3rd postoperative month). 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 29 Jan 2025.