Affecting Factors for Chronic Pain After Sternotomy
Affecting Factors the Incidince of Chronic Pain After Sternotomy
1 other identifier
observational
500
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 2, 2024
CompletedStudy Start
First participant enrolled
September 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedJanuary 29, 2025
January 1, 2025
1.5 years
July 30, 2024
January 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Interventions
Factors affecting the occurrence of chronic pain in patients undergoing open cardiac surgery with sternotomy will be investigated.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ankara Etlik City Hospital
Ankara, Ankara, 06290, Turkey (Türkiye)
Ankara Etlik City Hospital
Ankara, Yenimahalle, 06010, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jülide Ergil, Professor
WHO, Turkish Society of Anesthesiology and Reanimation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal İnvestigator
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 2, 2024
Study Start
September 1, 2024
Primary Completion
March 10, 2026
Study Completion
March 30, 2026
Last Updated
January 29, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share