Methadone versus fentanil and oxycodone for post-operative pain reduction in patients undergoing coronary artery bypass grafting and/or valve surgery – a placebo-controlled, double-blind, randomized clinical trial
After heart surgery, many patients still have a lot of pain and need strong pain relief, which can sometimes lead to problems and a slower recovery. This study is exploring different pain medications – methadone, fentanyl, and oxycodone – to see which one works best. It's a 'placebo-controlled' study, meaning some patients might receive a dummy treatment, and 'double-blind,' so neither patients nor their doctors will know who is getting which medicine. This helps make the results fairer and more accurate. The main aim is to see which medicine helps patients use less strong pain relief in the first two days after surgery, and also how it affects their pain levels, recovery time, and overall quality of life.
At a glance
What is this study about?
Heart surgery is a major operation, and it's common for people to experience significant pain afterwards. When pain isn't managed well, or if patients need a lot of strong pain relief (opioids), it can sometimes lead to other health problems and make recovery more difficult. This study is looking into whether using different pain medicines – methadone, fentanyl, or oxycodone – can help to reduce pain more effectively after heart surgery, specifically after coronary artery bypass grafting (a type of heart bypass) or valve surgery.
The researchers want to see which of these medicines helps patients use the least amount of strong pain relief in the first 48 hours after their operation. They'll also be checking how well pain is controlled when patients are resting and moving around, how quickly they recover and get out of bed, their stay in the intensive care unit, and their general well-being and quality of life in the weeks and months following surgery. The hope is that better pain control will lead to a smoother recovery and fewer complications for patients.
To make sure the results are as fair and reliable as possible, this study is 'double-blinded' and includes a 'placebo' group. This means that neither you nor your doctors will know which specific pain medicine you are receiving – it could be methadone, fentanyl, oxycodone, or a dummy treatment (placebo). This approach helps to ensure that any observed effects are truly due to the medications being tested, rather than other factors.
Key takeaways
- This study compares pain relief medicines after heart surgery.
- It aims to find the best way to manage pain and improve recovery.
- Participation involves monitoring after surgery and follow-up for 90 days.
- You will receive one of three common pain medicines or a placebo.
- The study helps doctors understand better pain management strategies for future patients.
Who may be eligible?
To take part in this study, you must be at least 18 years old. People of any gender are welcome to participate. The study is specifically for patients who are having heart surgery, either a coronary artery bypass graft (CABG) or heart valve surgery.
Your medical team will check if you meet all the specific health requirements for the study. They will also confirm that there are no reasons why you shouldn't take part, such as other medical conditions or medications that might interfere with the study treatments.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Are you scheduled for coronary artery bypass graft (CABG) or heart valve surgery?
- Do you understand that you might receive one of several pain medicines or a placebo?
- Are you able to attend follow-up appointments or complete questionnaires for up to 90 days?
What does participation involve?
If you decide to take part in this study, you would receive one of the study medications (methadone, fentanyl, oxycodone, or a dummy treatment) to help manage your pain after heart surgery. You'll be closely monitored by your medical team in the hospital. The main period of the study involves tracking your pain relief needs for the first two days after your operation. Your pain levels will be assessed regularly, both when you're resting and when you're doing physiotherapy exercises.
Researchers will also monitor how quickly you recover, including when you're able to get out of bed, how long you stay in the intensive care unit, and when you're ready to go home. You'll complete questionnaires about your quality of recovery and quality of life at various points after surgery, including on days 0, 1, 2, 3, 30, and 90. There will also be an assessment for chronic pain 30 and 90 days after your operation. The total duration of follow-up for the study is 90 days.
Potential risks and benefits
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Common questions
What kind of heart surgery is this study for?
This study is for patients having coronary artery bypass grafting (CABG) or heart valve surgery.
Will I know which pain medicine I am getting?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know which specific medicine you receive until after the study is complete. You might get methadone, fentanyl, oxycodone, or a placebo.
How long will I be involved in the study?
You'll be closely monitored in the hospital after surgery, and then there will be follow-up assessments for up to 90 days after your operation.
What is the main goal of the study?
The main goal is to see which pain medicine best reduces the amount of strong pain relief needed in the first two days after heart surgery, aiming for better recovery and fewer problems.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and this will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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