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Study on the Effects of Oxycodone and Paracetamol in Patients with Heart Valve or Coronary Artery Disease After Cardiac Surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients who have undergone heart surgery, specifically those with conditions like coronary artery disease, aortic valve disease, mitral valve disease, tricuspid valve disease, or a combination of these. The study is investigating the effects of a medication called oxycodone, which is used for pain relief. Oxycodone will be administered through a method called PCA, or patient-controlled analgesia, which allows patients to manage their pain by controlling the amount of medication they receive.

The purpose of the study is to evaluate how oxycodone affects breathing after heart surgery. Researchers will monitor patients' oxygen levels and breathing patterns to understand any changes that occur with the use of oxycodone. The study will also look at how much oxycodone is used and its concentration in the blood. Additionally, the study will assess pain levels, any complications from surgery, and overall quality of life after the surgery.

Participants in the study will receive either oxycodone or a placebo. The study will take place over a period of time, with regular check-ins to monitor the effects of the medication. The goal is to gather information on both the short-term and long-term outcomes of using oxycodone for pain management after heart surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be over 18 years old and scheduled for open heart surgery using cardiopulmonary bypass. Understanding of the study protocol and informed consent are required.

  2. Step 2

    Surgery and initial recovery

    Participants undergo cardiac surgery for conditions such as coronary artery disease or valve diseases. Recovery begins in the hospital where initial monitoring occurs.

  3. Step 3

    Medication administration

    Post-surgery, participants receive oxycodone through a method called PCA (patient-controlled analgesia) to manage pain. This involves self-administering the medication intravenously as needed, under medical supervision.

    Additionally, paracetamol is provided in the form of film-coated tablets for oral use to assist with pain management.

  4. Step 4

    Monitoring and data collection

    Throughout the hospital stay, participants' respiratory effects are closely monitored. This includes measuring peripheral oxygen saturation (SpO2), noting any desaturations, and recording respiratory rates.

    Pain levels are assessed daily using a numerical rating scale (NRS).

  5. Step 5

    Post-hospital follow-up

    After discharge, participants continue to report pain levels using the Brief Pain Inventory (BPI).

    Additional assessments include evaluating surgical complications, anxiety, depression, resilience, life satisfaction, and health-related quality of life.

  6. Step 6

    Study completion

    The study is expected to conclude by December 31, 2026. Data collected will contribute to understanding the respiratory effects and overall outcomes of using oxycodone PCA after cardiac surgery.

Who can join the trial?

4 criteria

  • Must be older than 18 years.
  • Must need open heart surgery. This surgery involves using a machine to help circulate blood while the heart is being operated on.
  • Must understand the study protocol, which means knowing what the study involves and what will happen during it.
  • Must agree to participate by giving informed consent, which means you understand the study and agree to take part.

Who cannot join the trial?

2 criteria

  • Having any of the following heart conditions: coronary artery disease (a problem with the blood vessels that supply the heart), aortic valve disease (a problem with the valve that controls blood flow from the heart to the body), mitral valve disease (a problem with the valve between the heart's left chambers), or tricuspid valve disease (a problem with the valve on the right side of the heart).
  • Being part of a vulnerable population, which means groups of people who might need special protection or care.
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Investigated drugs

Oxycodone is a medication used to relieve moderate to severe pain. In this clinical trial, it is administered through a patient-controlled analgesia (PCA) system, allowing patients to manage their pain by controlling the amount of medication they receive. The study aims to evaluate how oxycodone affects breathing, specifically looking at oxygen levels in the blood and breathing rates after cardiac surgery.

What is already known about the treatment

Oxycodone – Oxycodone is administered orally or intravenously, often using a patient-controlled analgesia (PCA) device, allowing patients to manage their pain after surgery. It is currently well-established in medical practice and literature as a potent pain reliever, particularly after surgical procedures. The main therapeutic indication for oxycodone is the management of moderate to severe pain. At the molecular level, oxycodone works by binding to opioid receptors in the brain and spinal cord, altering the perception of pain. It is classified pharmacologically as an opioid analgesic.

Investigated diseases

  • Coronary Artery Disease

    This condition involves the narrowing or blockage of the coronary arteries, usually due to a buildup of cholesterol and fatty deposits called plaques. Over time, these plaques can harden or rupture, leading to reduced blood flow to the heart muscle. This can cause chest pain, known as angina, especially during physical activity or stress. If a plaque ruptures, it can lead to a heart attack. The disease progresses as the arteries become increasingly narrowed, potentially leading to more severe symptoms and complications.

  • Aortic Valve Disease

    This disease affects the aortic valve in the heart, which controls blood flow from the heart to the aorta and onward to the rest of the body. It can involve either narrowing (stenosis) or leaking (regurgitation) of the valve. As the condition progresses, it can lead to symptoms such as shortness of breath, fatigue, and chest pain. Over time, the heart may have to work harder to pump blood, which can lead to heart failure if untreated.

  • Mitral Valve Disease

    This condition affects the mitral valve, which regulates blood flow between the left atrium and left ventricle of the heart. It can involve mitral valve stenosis, where the valve does not open fully, or mitral valve regurgitation, where the valve does not close properly. As the disease progresses, it can cause symptoms like shortness of breath, fatigue, and irregular heartbeats. The heart may become enlarged or weakened over time due to increased workload.

  • Tricuspid Valve Disease

    This disease affects the tricuspid valve, which controls blood flow between the right atrium and right ventricle. It can involve tricuspid stenosis or regurgitation, leading to improper blood flow through the heart. As the condition progresses, it can cause symptoms such as swelling in the abdomen or legs, fatigue, and irregular heart rhythms. Over time, it can lead to complications such as heart failure if not managed properly.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515530-33-00Protocol code2024-515530-33-00Estimated enrolment100 patientsSponsorPohjois-Savon hyvinvointialue

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