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Идёт набор NCT06534372

Affecting Factors for Chronic Pain After Sternotomy

Наблюдательное Cardiac Surgery Sternotomy Pain, Acute Pain, Chronic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Open cardiac surgery with sternotomy.
Кому может быть актуально
Состояния в реестре: Cardiac Surgery, Sternotomy, Pain, Acute, Pain, Chronic. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Affecting Factors the Incidince of Chronic Pain After Sternotomy

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months. [Срок оценки: 3rd postoperative month]
Вторичные конечные точки (4)
  • Self-leeds assessment of neuropathic symptoms and sign findings at 6th months [Срок оценки: 6th postoperative month]
  • Short Form 12 scores in the 3rd month. [Срок оценки: 3rd postoperative month]
  • Short Form 12 scores in the 6th month. [Срок оценки: 6th postoperative month]
  • Acute pain score [Срок оценки: Up to postoperative 24 hour]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 2 центра
  • Ankara Etlik City Hospital — Ankara
  • Ankara Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT06534372 · AEŞH-EK1-2024-0068

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗