In short
Currently, there is 1 ongoing clinical trial related to tricuspid valve disease. This trial is investigating pain management following heart surgery in patients with various heart valve conditions, including tricuspid valve disease. The study is being conducted in Finland and focuses on the effects of oxycodone, a pain relief medication, on breathing and recovery after cardiac 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 heart conditions. The study examines how pain medication affects recovery following cardiac surgery.
Who can join this trial?
To participate in this study, you must meet the following criteria:
- Be at least 18 years old
- Be scheduled for open heart surgery using cardiopulmonary bypass, which is a machine that helps circulate blood while your heart is being operated on
- Understand what the study involves and what will happen during your participation
- Provide informed consent, meaning you agree to take part after understanding the study details
Who cannot join this trial?
You cannot participate if you belong to a vulnerable population that might need special protection or care. It's important to note that the exclusion criteria mention having heart valve conditions, but this appears to apply to the general population being screened, as the trial specifically includes patients with these conditions who are undergoing surgery.
What is the trial investigating?
The main focus of this research is to understand how oxycodone, a medication used for pain relief, affects breathing after heart surgery. Oxycodone is given through a system called patient-controlled analgesia (PCA), which allows you to manage your own pain by controlling when you receive the medication through an intravenous line.
Researchers will carefully monitor several aspects of your recovery, including:
- Your oxygen levels in the blood
- Your breathing patterns and respiratory rate
- How much oxycodone you use and its concentration in your blood
- Your pain levels using rating scales
- Any complications from the surgery
- Your overall quality of life after surgery
What medication is being tested?
The investigational drug in this trial is oxycodone, a powerful pain reliever used to manage moderate to severe pain. In this study, oxycodone is administered through the PCA system, giving you control over your pain management after surgery. Additionally, paracetamol is provided as film-coated tablets to help with pain relief.
Oxycodone works at the molecular level by binding to specific receptors in your brain and spinal cord, changing how your body perceives pain. Some participants will receive oxycodone, while others will receive a placebo, allowing researchers to compare the effects.
What happens during the trial?
After your cardiac surgery, you will begin recovery in the hospital where medical staff will closely monitor you. You will use the PCA system to manage your pain with oxycodone as needed. Throughout your hospital stay, healthcare providers will track your breathing, oxygen levels, and pain scores daily.
After you leave the hospital, you will continue to report your pain levels and participate in assessments that evaluate surgical complications, anxiety, depression, resilience, life satisfaction, and overall health-related quality of life. The study is expected to conclude by December 31, 2026.
Summary
Currently, there is only one active clinical trial specifically including patients with tricuspid valve disease. This trial is being conducted in Finland and focuses on post-surgical pain management rather than treating the valve condition itself. The study aims to better understand how oxycodone affects breathing and recovery outcomes in patients who have undergone cardiac surgery for various heart conditions. This research may help improve pain management protocols for future cardiac surgery patients, ensuring safer and more effective recovery strategies.