TRAMORNOT: Tramadol versus morphine in postoperative analgesia after laparoscopic abdominal surgery: a randomized controlled trial
This research study is looking at two common pain medications, tramadol and morphine, to see which works best for pain after a type of surgery called laparoscopic abdominal surgery, which uses small cuts. The main goal is to find out which medicine helps patients recover better in the first 24 hours after their operation. They are using a special questionnaire called the QoR-15 to measure how well people are feeling. The study will also look at how much pain people have, how much pain medicine they use, and if they experience any side effects like sickness or itching. By comparing these two medicines, doctors hope to learn how to manage pain more effectively for patients after this kind of surgery.
At a glance
What is this study about?
Imagine you're having an operation where doctors use small cameras and tools through tiny cuts in your tummy – this is called keyhole (or laparoscopic) abdominal surgery. After such an operation, managing pain is super important for a good recovery.
This study, called TRAMORNOT, is comparing two pain medicines that are often used: tramadol and morphine. Doctors want to understand which one helps patients feel better and recover more quickly after this type of surgery. They are especially interested in how people feel 24 hours after their operation, using a special questionnaire that asks about different aspects of their well-being, like their comfort, emotional state, and ability to do daily tasks.
Beyond just pain relief, the study will also track other important things. This includes how much pain patients feel over a few days, how much of the pain medicine they need, and if they experience any unwanted side effects such as feeling sick, itching, or confusion. They will also look at how long people stay in the hospital and even check if they develop long-lasting pain after three months. The aim is to find the best way to help you recover comfortably and safely.
Key takeaways
- Compares tramadol and morphine for pain after keyhole abdominal surgery.
- Aims to find which medicine helps patients recover better after 24 hours.
- Checks for pain levels, amount of medicine used, and side effects.
- Involves follow-ups for up to three months after surgery.
- Participants must be over 18 and having specific keyhole surgery.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. People of any gender can take part.
Crucially, you would need to be scheduled for major laparoscopic abdominal surgery. This means the study is specifically for people who are having a planned operation that involves keyhole surgery in their tummy area.
The study will screen participants to ensure they meet all the specific health criteria needed for a clinical trial to be safe and effective. This ensures that the results are reliable and that all participants are suitable for the treatments being tested.
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 a major keyhole (laparoscopic) abdominal surgery?
- Are you comfortable filling out questionnaires about your pain and recovery?
- Are you able to attend follow-up appointments or phone calls for up to 3 months?
What does participation involve?
If you decide to join this study, you would receive either tramadol or morphine to help manage your pain after your keyhole abdominal surgery. The doctors running the study will decide which one you receive, similar to how patients usually get pain relief in hospital. You wouldn't know which medicine you are getting, and neither would your doctors, to keep the study fair.
Throughout your hospital stay, you would be asked about your pain levels and how you are feeling using questionnaires, including the special QoR-15 questionnaire, at 24, 48, and 72 hours after surgery. Doctors and nurses would also keep track of any side effects you might have. They'd also note how long you stay in the recovery room and in the hospital overall.
After you go home, there would be follow-up checks at 1 month and 3 months to see if you are still taking pain medication daily or if you have any ongoing pain. This helps the researchers understand the long-term effects of the pain relief given during and after surgery. The total duration of your participation would be about three months after your surgery.
Potential risks and benefits
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Common questions
What kind of surgery is this study for?
This study is for people having planned keyhole surgery involving the tummy area (major laparoscopic abdominal surgery).
What pain medicines are being compared?
The study is comparing two common pain medications: tramadol and morphine.
How will they know which medicine works best?
Researchers will use a special questionnaire (QoR-15) to see how well patients recover, especially 24 hours after surgery, and will also look at pain levels and side effects.
How long will I be involved in the study?
You would be involved for about three months after your surgery, with checks during your hospital stay and at 1 and 3 months after going home.
Can I stop being part of the study once I've started?
Yes, you are always free to leave the study at any time without it affecting your medical care.
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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