Clinical trial NCT06534372: Affecting Factors for Chronic Pain After Sternotomy
Official title: Affecting Factors the Incidince of Chronic Pain After Sternotomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery
Sternotomy
Pain, Acute
Pain, Chronic
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-02
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
timeFrame: 3rd postoperative month
Secondary outcomes:
measure: Self-leeds assessment of neuropathic symptoms and sign findings at 6th months
timeFrame: 6th postoperative month
measure: Short Form 12 scores in the 3rd month.
timeFrame: 3rd postoperative month
measure: Short Form 12 scores in the 6th month.
timeFrame: 6th postoperative month
measure: Acute pain score
timeFrame: Up to postoperative 24 hour
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Yenimahalle
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: WHO, Turkish Society of Anesthesiology and Reanimation
name: Jülide Ergil, Professor
role: STUDY_DIRECTOR
References: