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临床试验/NCT06534372
NCT06534372招募中不适用

Affecting Factors the Incidince of Chronic Pain After Sternotomy

Ankara Etlik City Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Ankara Etlik City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Umut Can Özağar

Principal İnvestigator

Ankara Etlik City Hospital

研究点 (1)

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