Affecting Factors for Chronic Pain After Sternotomy

NCT ID: NCT06534372

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-03-30

Brief Summary

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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

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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

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Cardiac Surgery Sternotomy Pain, Acute Pain, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Open cardiac surgery with sternotomy

Factors affecting the occurrence of chronic pain in patients undergoing open cardiac surgery with sternotomy will be investigated.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Umut Can Özağar

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jülide Ergil, Professor

Role: STUDY_DIRECTOR

WHO, Turkish Society of Anesthesiology and Reanimation

Locations

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Ankara Etlik City Hospital

Ankara, Ankara, Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ankara Etlik City Hospital

Ankara, Yenimahalle, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Umut Can Özağar, M.D.

Role: CONTACT

00905546271611

Jülide Ergil, Professor

Role: CONTACT

00905323469216

Facility Contacts

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Umut Can Özağar, M.D.

Role: primary

00905546271611

Julide Ergil, Professor

Role: backup

00905323469216

Jülide Ergil

Role: primary

+903127970000 ext. 123129

Other Identifiers

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AEŞH-EK1-2024-0068

Identifier Type: -

Identifier Source: org_study_id

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