Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Rebound pain after volar plate surgery in infraclavicular brachial plexus block with ropivacaine 3.75 mg/ml compared with 7.5 mg/ml. A prospective, triple blinded randomised controlled trial

This research focuses on people having surgery for a broken wrist. Doctors want to understand the best way to manage pain after this type of surgery. They are comparing two different strengths of a pain-blocking medicine, called ropivacaine, which is given as an injection near the nerves in the arm (an 'infraclavicular brachial plexus block'). The main goal is to see if one strength is better at reducing pain, particularly the pain that can come back as the nerve block wears off, often called 'rebound pain.' They will also look at how much other pain relief people need and how their recovery goes over several weeks. This is a Phase IV study, meaning the medicines are already approved for use, and researchers are gathering more information on their best use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Oslo University Hospital HF

Enrolment target

Start

15 Jan 2025

Radius fracture

What is this study about?

Imagine you've broken your wrist and need surgery. To help with the pain, doctors often give you a special injection that numbs your arm, called a nerve block. This study is all about finding the best strength of one of these numbing medicines, called ropivacaine. They are comparing a standard dose with a slightly higher dose to see which one works better for pain control after a specific type of wrist surgery involving a plate. The surgery is for a 'radius fracture,' which is a common type of broken wrist.

The main thing the doctors want to know is what your worst pain is like in the first two days after the surgery. They'll ask you to rate your pain on a scale, which helps them understand how well the different medicine strengths are working. They are especially interested in something called 'rebound pain.' This is when the numbing medicine wears off, and the pain might suddenly become much stronger. They want to see if one strength of ropivacaine helps reduce this 'rebound' effect.

But it's not just about the pain right after surgery. The study also looks at other important things. For example, they'll check how much other pain relief medicines (like paracetamol or stronger painkillers) you need, how long any moderate or strong pain lasts, and how your pain changes over seven days and even up to six weeks later. They'll also ask about your sleep, how easy it is to do daily activities, and your overall satisfaction with your pain treatment. All this information helps doctors understand the best way to keep you comfortable and help you recover well after your wrist surgery.

Key takeaways

The study explores the best dose of nerve-blocking medicine (ropivacaine) for wrist surgery.
It aims to reduce pain, especially 'rebound pain' as the block wears off.
Researchers will track your pain levels and any other painkillers you use.
Your recovery, sleep, and daily activities will be monitored for up to six weeks.
This research helps improve pain relief for future patients having similar wrist surgery.

Who may be eligible?

To be able to take part in this study, you need to be at least 18 years old. The study is open to both men and women.

The main reason you would be considered for this study is if you are having surgery for a specific type of broken wrist, called a 'radius fracture.' The surgery involves a 'volar plate,' which is a small metal plate used to help fix the bone.

There might be other reasons why you wouldn't be able to join, even if you meet these main points. For example, if you have certain other health conditions, are taking particular medications, or have known allergies to the study drugs, the doctors might decide it's not safe for you to participate. This is to ensure your well-being throughout the study.

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 surgery for a broken wrist (radius fracture) involving a 'volar plate'?
Are you able to reliably understand and answer questions about your pain?
Do you have any known allergies to commonly used pain medications or local anaesthetics?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a meeting with the study team to make sure it's right for you. If you qualify, you would receive one of two strengths of the nerve-blocking medicine (ropivacaine) during your wrist surgery. You won't know which strength you're getting, and neither will your doctors or the study nurses – this helps keep the study fair and unbiased.

After your surgery, the study team will regularly ask you about your pain levels over the first 48 hours, and then at specific times like 3 days, 7 days, and 6 weeks after your operation. You'll use a simple scale to rate your pain. They will also keep track of any other pain relief medicines you take, like paracetamol or stronger painkillers such as OxyNorm or Arcoxia. You might also be asked about your ability to sleep, do daily activities, and your general well-being at different points.

The total duration of your active participation, where you're regularly providing information, would be about six weeks after your surgery. Throughout this time, you'll be giving feedback on how you're feeling and how your recovery is progressing.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving close monitoring of your pain relief after surgery, which could lead to better pain management. The information gathered will also help doctors improve pain treatment for future patients with similar injuries. However, as with any medical procedure or study, there are potential risks. While ropivacaine and the other pain medications are commonly used, there are always very rare chances of side effects, allergies, or issues related to the nerve block itself. The study team will closely monitor you for any such concerns. You have the absolute right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is a 'nerve block'?

A nerve block is an injection that numbs a specific area of your body by temporarily stopping nerves from sending pain signals. In this study, it's given in your arm for wrist surgery.

What is 'rebound pain'?

Rebound pain is when pain can increase quite suddenly when the effect of a nerve block wears off. This study is looking at ways to make that less likely.

Will I know which dose of medicine I'm getting?

No, you won't know if you're getting the lower or higher dose of the nerve block. This helps make sure the study results are fair and unbiased.

What happens if I'm still in pain after the nerve block?

You will be given other pain relief medicines as needed, such as paracetamol or stronger painkillers, to ensure your comfort after surgery.

How long will I be involved in the study?

You'll be involved in providing information about your pain and recovery for about six weeks after your wrist surgery.