Multicentre, open-label, randomized controlled non-inferiority trial comparing single dose intrathecal morphine and continuous thoracic epidural analgesia for multimodal analgesia in open colorectal surgery: the ColoREDIT protocol
This study, called ColoREDIT, is looking at the best ways to manage pain after major bowel surgery. When you have this type of surgery, doctors need to make sure you have good pain relief afterwards to help you recover well. This study specifically compares two main approaches: a single dose of morphine injected into the spine (backbone) and a continuous drip of pain medication given through a small tube placed in the back, often called an epidural. The main goal is to see if the single morphine injection helps people recover just as well as the epidural, by looking at their overall recovery and how much pain they experience. The study also checks how satisfied patients are with their pain relief, how long they stay in hospital, and if there are any long-term effects.
At a glance
What is this study about?
When you have surgery on your bowel (colorectal surgery), good pain relief afterwards is really important for your recovery. This study, called ColoREDIT, is designed to compare two common ways of managing pain after this type of operation. One method involves a single injection of a pain medicine called morphine into the fluid around your spinal cord, which can provide pain relief for a longer period. The other method uses a small tube (epidural) placed in your back, through which pain medicine is continuously given to keep you comfortable. Both methods are already used in hospitals.
The main aim of this study is to find out if the single morphine injection is just as effective as the continuous epidural in helping you recover well after surgery. Researchers will be looking at how well people feel two days after their operation, taking into account how they felt before surgery. They will also measure other important things like how much pain you feel, how happy you are with your pain management, how long you stay in hospital, and your general quality of life.
By comparing these two methods, doctors hope to understand which one offers the best balance of pain relief and recovery for patients undergoing bowel surgery. This could help them make better choices for future patients, ensuring everyone gets the most suitable and effective pain management for their surgery.
Key takeaways
- Compares two common pain relief methods after bowel surgery.
- Aims to see if a single spinal morphine injection is as effective as a continuous epidural.
- Evaluates overall recovery, pain levels, and satisfaction.
- Follows patients for up to one year to track long-term effects.
- Helps doctors choose the best pain management for future patients.
Who may be eligible?
This study is looking for adult patients who need to have surgery on their bowel. This type of surgery typically involves making a cut down the middle of your tummy (abdomen).
You would be considered for this study if you are 18 years old or over, and both men and women can take part. The surgery you're having must be for a condition that requires a section of your bowel to be removed.
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 having bowel surgery where part of your bowel needs to be removed?
- Will your surgery involve a cut down the middle of your tummy?
- Are you able to understand and agree to take part in the study?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive one of the two pain relief methods: either a single injection of morphine into your spine, or continuous pain medicine through an epidural in your back. The doctors and nurses looking after you will know which treatment you are receiving, but the choice is made at random, like flipping a coin.
Before your surgery, you will have a visit to assess your health. After your surgery, the research team will check on your recovery and pain levels regularly, often daily for the first week, and then again after about a month and a year. This will involve answering questions about your pain, how you're feeling, and your overall recovery. They will also keep track of any pain medicines you're given and how long you stay in hospital. You can expect to answer questions about your health and recovery for up to a year after your surgery, usually through questionnaires.
Potential risks and benefits
Locations (1)
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Common questions
What kind of surgery is this trial for?
This trial is for patients needing surgery to remove part of their bowel, usually with a cut down the centre of their tummy.
What pain relief methods are being compared?
Doctors are comparing a single injection of morphine into the spine versus continuous pain medicine through a tube in the back (epidural).
Will I get to choose my pain relief?
No, the type of pain relief you receive will be chosen at random, similar to drawing straws. This ensures the study is fair.
How long will I be followed up for?
You will be followed up for about a year after your surgery to see how your recovery progresses long-term.
What is the main thing the study is trying to find out?
The study wants to know if a single morphine injection is just as good as an epidural for helping people recover well after bowel surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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