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Clinical Trials/NCT06534372
NCT06534372
Recruiting
Not Applicable

Affecting Factors the Incidince of Chronic Pain After Sternotomy

Ankara Etlik City Hospital1 site in 1 country500 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Surgery
Sponsor
Ankara Etlik City Hospital
Enrollment
500
Locations
1
Primary Endpoint
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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, we 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, we 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.

Our study does not pose any risk for the patients to be included.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
March 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Ankara Etlik City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Umut Can Özağar

Principal İnvestigator

Ankara Etlik City Hospital

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Self-leeds assessment of neuropathic symptoms and sign findings at 6th months(6th postoperative month)
  • Short Form 12 scores in the 3rd month.(3rd postoperative month)
  • Short Form 12 scores in the 6th month.(6th postoperative month)
  • Acute pain score(Up to postoperative 24 hour)

Study Sites (1)

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