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Study on Methadone, Fentanyl, and Oxycodone for Reducing Pain After Heart Surgery in Adults

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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 improving pain management for patients who have undergone heart surgery, specifically coronary artery bypass grafting and/or valve surgery. After such surgeries, patients often experience significant pain and require high amounts of pain-relieving medications, which can lead to negative side effects and poor recovery outcomes. The study aims to compare the effectiveness of a single dose of methadone given during surgery with the usual care, which involves the use of fentanyl and oxycodone, in reducing the need for additional pain medication after surgery.

Participants in the study will receive one of the treatments during their surgery. The study will monitor the amount of pain medication needed after surgery, as well as other factors like pain levels, recovery time, and overall quality of life. The trial will also look at how quickly patients can be discharged from the hospital and any complications that may arise, such as irregular heartbeats or delayed bowel function.

The goal of this research is to find the most effective way to manage pain after heart surgery, which could lead to better recovery experiences for patients. By comparing methadone with the more commonly used fentanyl and oxycodone, the study hopes to identify a treatment that reduces the need for additional pain medication and improves overall patient outcomes.

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

    Eligibility for the study requires being 18 years or older and scheduled for coronary artery bypass grafting (CABG) and/or valve surgery.

    No specific exclusion criteria are mentioned.

  2. Step 2

    Pre-surgery preparation

    Before surgery, anesthesia is induced. At this point, a single dose of methadone is administered to evaluate its effectiveness in reducing post-operative pain.

  3. Step 3

    During surgery

    During the operation, usual care involves the administration of fentanyl and oxycodone to manage pain.

  4. Step 4

    Post-surgery monitoring

    After surgery, the primary focus is on monitoring the total consumption of opioids equivalent to morphine within 48 hours.

    Pain intensity is assessed using the Numeric Rating Scale (NRS) at rest, during coughing, and during physiotherapy.

  5. Step 5

    Recovery and assessment

    The time from arrival in the cardiac intensive care unit (CICU) until extubation and mobilization is recorded.

    The length of stay in the CICU and the time until bowel function returns are monitored.

    Quality of recovery is assessed on postoperative days 0, 1, 2, 3, 30, and 90.

    Quality of life is evaluated 90 days after surgery using the SF-36 questionnaire.

  6. Step 6

    Long-term follow-up

    Chronic pain is assessed at 30 and 90 days post-surgery.

    The time to hospital discharge and any occurrences of postoperative arrhythmias are documented.

    Mortality is tracked over a period of 3 months.

Who can join the trial?

4 criteria

  • Must be **18 years or older**.
  • Scheduled for **CABG** (Coronary Artery Bypass Grafting) and/or **valve surgery**. These are types of heart surgeries.
  • Both **male and female** participants are eligible.
  • Participants should not belong to a **vulnerable population**. This means they should not be in a group that might need special protection or care.

Who cannot join the trial?

5 criteria

  • Patients who have had recent heart surgery and are experiencing poor pain control after the operation.
  • Patients who are consuming a moderate to high amount of **opioids**. Opioids are strong pain-relieving medications.
  • Patients who are not adults. This means the study is only for people who are 18 years or older.
  • Patients who are not undergoing planned or urgent **CABG** or valve surgery. CABG stands for Coronary Artery Bypass Grafting, a type of heart surgery.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care.
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Investigated drugs

  • Methadone

    is being tested in this trial to see if it can help reduce the need for other pain medications after surgery. It is given as a single dose during the operation, right after the patient is put under anesthesia. The goal is to see if this approach can effectively manage pain after heart surgery.

  • Fentanil

    is used as part of the usual care for managing pain during and after surgery. In this trial, it is given during the operation to help control pain. The study is comparing its effectiveness to methadone.

  • Oxycodone

    is another medication used in the usual care for pain management in this trial. It is administered during the operation to help reduce pain. The trial aims to compare its effectiveness with methadone in managing post-operative pain.

What is already known about the treatment

  • Methadone

    Methadone is administered as a single dose during surgery, specifically after anesthesia is induced. It is currently being studied in clinical trials to assess its effectiveness in reducing postoperative pain and opioid consumption in patients undergoing heart surgery. Methadone is primarily used for pain management and opioid addiction treatment. It works by binding to opioid receptors in the brain, altering the perception of pain and providing relief. Methadone is classified as an opioid analgesic.

  • Fentanyl

    Fentanyl is typically administered during surgery to manage pain, often as part of the standard care for patients undergoing heart surgery. It is a well-established medication in medical practice, known for its potent pain-relieving properties. Fentanyl acts by binding to opioid receptors in the brain, providing significant pain relief. It is classified as an opioid analgesic.

  • Oxycodone

    Oxycodone is administered during surgery to help control pain, commonly used alongside other medications like fentanyl. It is widely recognized in medical literature for its effectiveness in managing moderate to severe pain. Oxycodone works by binding to opioid receptors in the central nervous system, altering the body's response to pain. It is classified as an opioid analgesic.

Investigated diseases

Pain Following Heart Surgery – After heart surgery, patients often experience significant pain, which can be challenging to manage effectively. This pain is typically due to the surgical incision and manipulation of tissues during the procedure. Poor pain control can lead to increased consumption of opioids, which are medications used to relieve pain. The use of opioids, while effective, can be associated with adverse effects and complications. Managing this pain effectively is crucial to improve recovery and reduce the need for high doses of pain medication.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519224-24-00Protocol code4000Estimated enrolment110 patientsSponsorRegion Hovedstaden

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