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Affecting Factors for Chronic Pain After Sternotomy

Affecting Factors the Incidince of Chronic Pain After Sternotomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06534372
Enrollment
500
Registered
2024-08-02
Start date
2024-09-01
Completion date
2026-03-30
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Pain, Acute, Pain, Chronic, Sternotomy

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.

Interventions

PROCEDUREOpen cardiac surgery with sternotomy

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

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.3rd postoperative monthPatients' 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

MeasureTime frameDescription
Self-leeds assessment of neuropathic symptoms and sign findings at 6th months6th postoperative monthPatients' 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.
Short Form 12 scores in the 3rd month.3rd postoperative monthShort Form 12 scores will be evaluated in the 3rd month to evaluate the quality of life of the patients.
Short Form 12 scores in the 6th month.6th postoperative monthShort Form 12 scores will be evaluated in the 6th month to evaluate the quality of life of the patients.
Acute pain scoreUp to postoperative 24 hourPain 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactUmut Can Özağar, M.D.
ozagarumutcan@hotmail.com00905546271611
Backup ContactJülide Ergil, Professor
julideergil@hotmail.com00905323469216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026