Study on the Effects of Oxycodone and Paracetamol in Patients with Heart Valve or Coronary Artery Disease After Cardiac Surgery
This clinical trial is being conducted in Finland and focuses on patients who have undergone heart surgery for conditions including coronary artery disease, aortic valve disease, mitral valve disease, tricuspid valve disease, or a combination of these conditions.
Main inclusion criteria:
- Must be over 18 years old
- Must be scheduled for open heart surgery using cardiopulmonary bypass (a machine that helps circulate blood during the operation)
- Must understand the study protocol and what participation involves
- Must provide informed consent, meaning you agree to take part after understanding the study details
Main exclusion criteria:
- The trial has specific exclusion criteria related to certain heart conditions and vulnerable populations, though the specific details should be discussed with the research team
Focus and goals of the trial:
The main purpose of this study is to evaluate how oxycodone affects breathing after heart surgery. Oxycodone is a pain medication that will be given through a system called patient-controlled analgesia, or PCA. This system allows patients to manage their own pain by controlling how much medication they receive within safe limits.
Researchers will carefully monitor participants' oxygen levels and breathing patterns to understand any changes that occur when using oxycodone. They will also track how much medication is used and measure its concentration in the blood. Additionally, the study will assess pain levels throughout recovery, any complications from surgery, and overall quality of life after the procedure.
Participants will receive either oxycodone or a placebo (an inactive substance) for comparison. Along with oxycodone administered through PCA, participants will also receive paracetamol in tablet form to help manage pain. The study involves regular check-ins to monitor the effects of the medication, both during the hospital stay and after discharge.
Investigational drug:
The main medication being studied is oxycodone, a pain reliever used to treat moderate to severe pain. It works by binding to specific receptors in the brain and spinal cord that change how pain is perceived. In this trial, oxycodone is delivered through a PCA system, which gives patients control over their pain management while ensuring they stay within safe dosage limits. The study aims to better understand how this medication affects breathing function after cardiac surgery, which is important information for improving post-surgical care.
The study is expected to be completed by December 31, 2026, and will provide valuable information about both short-term and long-term outcomes of using oxycodone for pain management after heart surgery.
Germany