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NCT Number: NCT06534372

Affecting Factors for 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital, Ankara, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open cardiac surgery with sternotomy

Procedure

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

Primary outcomes

  1. 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

  1. Self-leeds assessment of neuropathic symptoms and sign findings at 6th months

    Time frame: 6th 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.

  2. Short Form 12 scores in the 3rd month.

    Time frame: 3rd postoperative month

    Short Form 12 scores will be evaluated in the 3rd month to evaluate the quality of life of the patients.

  3. Short Form 12 scores in the 6th month.

    Time frame: 6th postoperative month

    Short Form 12 scores will be evaluated in the 6th month to evaluate the quality of life of the patients.

  4. Acute pain score

    Time frame: Up to postoperative 24 hour

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jülide Ergil, Professor

CONTACT

[email protected]

00905323469216

Umut Can Özağar, M.D.

CONTACT

[email protected]

00905546271611

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

Affecting Factors the Incidince of Chronic Pain After Sternotomy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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