Affecting Factors for Chronic Pain After Sternotomy

Affecting Factors the Incidince of 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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Cardiac Surgery; Pain, Chronic; Sternotomy
• Intervention / Treatment: Procedure: Open cardiac surgery with 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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Umut Can Özağar, M.D.; Phone Number: 00905546271611; Email: ozagarumutcan@hotmail.com
• Study Contact Backup: Name: Jülide Ergil, Professor; Phone Number: 00905323469216; Email: julideergil@hotmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06290
    • Not yet recruiting
    • Ankara Etlik City Hospital
    • Contact: Umut Can Özağar, M.D.; Phone Number: 00905546271611; Email: ozagarumutcan@hotmail.com
    • Contact: Jülide Ergil, Professor; Phone Number: 00905323469216; Email: julideergil@hotmail.com
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey, 06010
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: Jülide Ergil; Phone Number: 123129 +903127970000; Email: julideergil@hotmail.com
      • Contact: Umut Can Özağar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients in the ASA I-II-III risk group, between the ages of 18-80 years, with a BMI between 18-35 kg/m2, who will undergo elective open coronary artery bypass graft surgery, who will undergo elective open heart valve surgery, who will undergo general anesthesia, and who will undergo sternotomy will be included in the study.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-leeds assessment of neuropathic symptoms and sign findings in 3rd months.	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.	3rd postoperative month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-leeds assessment of neuropathic symptoms and sign findings at 6th months	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.	6th postoperative month
Short Form 12 scores in the 3rd month.	Short Form 12 scores will be evaluated in the 3rd month to evaluate the quality of life of the patients.	3rd postoperative month
Short Form 12 scores in the 6th month.	Short Form 12 scores will be evaluated in the 6th month to evaluate the quality of life of the patients.	6th postoperative month
Acute pain score	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.	Up to postoperative 24 hour

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital
• Investigators: Study Director: Jülide Ergil, Professor, WHO, Turkish Society of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): March 10, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: AEŞH-EK1-2024-0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No