Ongoing Clinical Trials for Aortic Valve Disease
Currently, there is 1 ongoing clinical trial investigating pain management after cardiac surgery in patients with aortic valve disease. This study is evaluating the effects of oxycodone on breathing and pain relief following heart surgery.
Clinical trial locations
Study on the Effects of Oxycodone and Paracetamol in Patients with Heart Valve or Coronary Artery Disease After Cardiac Surgery
This clinical trial is designed for patients who have undergone open heart surgery for conditions including coronary artery disease, aortic valve disease, mitral valve disease, tricuspid valve disease, or a combination of these conditions. The study is taking place in Finland and focuses on pain management after cardiac surgery.
Inclusion criteria: To participate in this study, you must be over 18 years old and scheduled for open heart surgery that uses cardiopulmonary bypass, which is a machine that helps circulate blood while the heart is being operated on. You need to understand what the study involves and give your informed consent to participate.
Exclusion criteria: You cannot participate if you are part of a vulnerable population that might need special protection or care. Interestingly, having coronary artery disease or valve diseases including aortic, mitral, or tricuspid valve disease is listed in the exclusion criteria, though these are the conditions being studied, which suggests this may apply to specific circumstances within the broader patient population.
Study focus: The main goal of this trial is to evaluate how oxycodone, a pain relief medication, affects breathing after heart surgery. Researchers will monitor patients’ oxygen levels and breathing patterns to understand any changes that occur with the use of this medication. The study will also measure how much oxycodone is used, its concentration in the blood, pain levels, any complications from surgery, and overall quality of life after the procedure.
How the study works: After surgery, participants will receive oxycodone through a system called patient-controlled analgesia, or PCA. This allows you to manage your own pain by controlling the amount of medication you receive through an intravenous line, under medical supervision. Additionally, paracetamol tablets will be provided to assist with pain management. Throughout your hospital stay, medical staff will closely monitor your breathing, oxygen levels, and pain levels. After you leave the hospital, you will continue to report your pain levels and complete assessments about any complications, anxiety, depression, and your overall quality of life. The study is expected to conclude by December 31, 2026.
Investigational drug: Oxycodone is a medication used to relieve moderate to severe pain. It works by binding to opioid receptors in the brain and spinal cord, which changes how your body perceives pain. In this study, oxycodone is being specifically evaluated for its effects on breathing and its effectiveness in managing pain after cardiac surgery.
Summary
Currently, there is only one clinical trial available for patients with aortic valve disease, located in Finland. This study specifically addresses an important aspect of post-surgical care: pain management and its effects on breathing after open heart surgery. The trial uses oxycodone administered through a patient-controlled system, giving patients some control over their pain relief while allowing researchers to carefully monitor respiratory effects. This research is valuable as it aims to better understand the balance between effective pain control and maintaining safe breathing patterns after major cardiac surgery. If you are scheduled for heart valve or coronary artery surgery in Finland, you may wish to discuss this trial with your surgical team to see if participation is right for you.
