Comparison of different doses of perineural dexmedetomidine as adjuvans to ropivacaine 0,67% for interscalene plexus block in association with 10 mg intravenous dexamethasone: a single center, double blinded, randomised controlled trial.
This research trial is investigating the best way to manage pain after shoulder surgery. It specifically looks at adding a drug called dexmedetomidine, in different amounts, to a local anaesthetic (ropivacaine) given as an injection near the nerves in your neck (called an interscalene block). This block helps to numb your arm and shoulder. The study also involves a single dose of intravenous dexamethasone. The main goal is to see which combination provides the longest-lasting pain relief, meaning you'll need fewer painkillers after surgery. Researchers will also be checking for side effects, how quickly you recover, and how much pain you experience in the first 48 hours.
At a glance
What is this study about?
If you're having shoulder surgery, managing pain afterwards is really important. This study is designed to help doctors find the most effective way to keep you comfortable. Currently, a common method is to use a local anaesthetic injection, called an interscalene block, which numbs your shoulder and arm during and after the operation. This trial is exploring if adding another medication, called dexmedetomidine, to this local anaesthetic can make the pain relief last longer.
Researchers are comparing different doses of dexmedetomidine to see which works best. They are also giving a small dose of dexamethasone through a drip. By doing this, they hope to understand how these medicines work together to reduce pain and enhance your recovery. The study is a "double-blinded" trial, which means neither you nor your doctors will know which dose you're receiving, ensuring the results are fair and unbiased.
The main thing the study wants to find out is how long it takes before you feel you need to take pain medication after surgery. They will also be looking at other important aspects like how long your arm stays numb, if you feel sick after the operation, and how quickly you recover from the anaesthetic. This information will help doctors improve pain management for future patients undergoing similar surgeries.
Key takeaways
- This study explores better pain relief after shoulder surgery.
- It tests different doses of dexmedetomidine with a local anaesthetic.
- The main goal is to find out which option provides the longest pain relief.
- Researchers will also check for side effects like nausea and recovery time.
- Participation involves close monitoring during your ordinary hospital stay.
Who may be eligible?
This study is looking for adult patients who are planning to have shoulder surgery. You must be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to participate.
The research team will have specific health requirements to make sure the study is safe for you and that the results are accurate. They will check your medical history to ensure you don't have any conditions that would make it unsafe for you to take part or affect the medicines being tested.
It's important to discuss your full medical history with the study team. They will explain all the requirements in detail and confirm whether this study is suitable for you.
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 aged 18 years or older?
- Are you scheduled to have shoulder surgery?
- Are you happy for your pain and recovery to be monitored for 48 hours after surgery?
- Are you able to understand and consent to take part in the study?
What does participation involve?
If you decide to take part in this study, the process will be integrated into your surgical pathway. You will receive the study medication – which includes local anaesthetic, dexmedetomidine (at one of the different doses being tested), and intravenous dexamethasone – before or during your shoulder operation. This will be given by the anaesthetic team as part of your pain management plan.
After your surgery, the research team will closely monitor your pain levels and recovery over the next 48 hours. This will involve you reporting when you first feel you need pain relief, and regularly answering questions about your pain using a simple scale (like 0-10). They will also ask about any sickness or other side effects you might experience. There won't be extra visits to the hospital specifically for the study, as all assessments will happen during your hospital stay for the surgery. The total duration of active participation and monitoring will be for the first 48 hours after your operation.
Potential risks and benefits
Locations (1)
- —UnverifiedBelgium
Common questions
What is an interscalene block?
It's an injection near the nerves in your neck that numbs your shoulder and arm, helping with pain during and after surgery.
What is dexmedetomidine?
It's a medicine that can be added to local anaesthetics to make the pain-relieving effects last longer, and it also has a sedative effect.
Will I know which dose of medication I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your doctors will know which specific dose you receive until the study is over. This helps keep the results fair.
Will this study add extra appointments for me?
No, all assessments and monitoring for the study will happen during your hospital stay for your shoulder surgery within the first 48 hours after your operation.
What if I change my mind about participating?
You are free to withdraw from the study at any time, for any reason, 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
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.