Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Effect of ultrasound guided lateral infraclavicular brachial plexus block with Lidocaine or Ropivacaine for closed reduction of distal radius fractures - A randomized controlled non-inferiority trial

This research study is comparing two common numbing medications, Lidocaine and Ropivacaine, used when someone breaks their wrist and needs the bone reset. Doctors often use a special technique called an ultrasound-guided nerve block to numb the arm before gently putting the bone back into place without surgery. The main goal of this study is to find out if Ropivacaine is just as effective as Lidocaine in numbing the arm within 45 minutes of giving the injection. This could help doctors choose the best pain relief for patients needing this procedure, making things more comfortable and efficient. This is a type of study that looks at treatments already in use to see how well they work in real-world settings.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Nordsjaellands Hospital

Enrolment target

Start

04 Apr 2024

Distal radius fractures with need of acute closed reduction

What is this study about?

When you break your wrist, sometimes the bones move out of place and need to be gently put back into their correct position. This process is called a 'closed reduction' because it's done without needing to cut open the skin. To make sure this isn't painful, doctors often inject numbing medicine near the nerves in your arm, guided by an ultrasound machine. This is like a very targeted local anaesthetic for your whole arm, helping you stay comfortable during the procedure.

This particular study is comparing two different numbing medicines: Lidocaine and Ropivacaine. Both are commonly used, but doctors want to see if one is as good as the other – or perhaps even better – at numbing the area quickly and effectively. By using ultrasound, they can see exactly where to inject the medicine, making the numbing process more precise.

The main thing researchers are looking at is how well the arm is numbed within 45 minutes after the injection. Finding out which medicine works best, or if they are equally good, will help doctors choose the most effective way to help patients with broken wrists, making their treatment more comfortable and successful.

Key takeaways

Researchers are comparing two common numbing medicines (Lidocaine and Ropivacaine) for broken wrists.
The study uses ultrasound to guide the injection for precise numbing.
The main goal is to see which medicine numbs the arm effectively within 45 minutes.
This research aims to help doctors choose the best pain relief for wrist fractures.
It's a study of existing treatments, not brand-new experimental drugs.

Who may be eligible?

To be part of this study, you would need to be 18 years old or older. There isn't an upper age limit, meaning people of all adult ages can take part. Both men and women are welcome to participate in this research.

The most important thing is that you have a broken wrist (what doctors call a 'distal radius fracture') and the medical team has decided that you need to have the bone gently put back into place without surgery. This procedure is known as an 'acute closed reduction'.

There might be other reasons why you couldn't join the study, for example, if you have certain other health conditions or allergies to the medications being used. The study team would discuss all of this with you to make sure it's safe for you to take part.

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?
Do you have a broken wrist (distal radius fracture)?
Has your doctor said you need a 'closed reduction' (bone reset without surgery)?
Are you able to provide informed consent (understand and agree to take part)?
Do you have any known allergies to Lidocaine or Ropivacaine? (If yes, you might not be eligible)

Answer every question to see your result.

What does participation involve?

If you decide to join this study, after you've broken your wrist and need it reset, you would be given one of the two numbing medications (Lidocaine or Ropivacaine) through an injection in your arm, guided by ultrasound. This is part of the standard care you would receive anyway to help with pain during the procedure.

The study team would then check how well your arm is numbed about 45 minutes after the injection. They would also watch you closely during the procedure to make sure you're comfortable and to see how effective the numbing medicine is. You wouldn't need extra hospital visits beyond what's needed for your broken wrist care. The total duration of your participation would be focused around your wrist reduction procedure and immediate recovery.

Potential risks and benefits

Taking part in this study means you'll receive a standard treatment for your broken wrist: a nerve block to numb your arm. The potential benefit is that you might receive a numbing medicine that is found to be very effective for quick pain relief during your procedure. As with any medical procedure involving injections, there are small risks like bruising, bleeding, or a slight infection at the injection site, or rarely, temporary nerve irritation. The study uses medicines already approved and widely used. You are always free to withdraw from the study at any time, for any reason, without it affecting your 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
Denmark

Common questions

What is a 'closed reduction' for a broken wrist?

It's a way doctors put a broken wrist bone back into place without needing surgery, by gently moving it from the outside.

What is a 'nerve block'?

It's an injection of numbing medicine near a nerve to make a specific part of your body, like your arm, go numb so you don't feel pain during a procedure.

Why use ultrasound?

The ultrasound machine helps the doctor see exactly where the nerves are, so they can inject the numbing medicine in the right place more accurately.

Will I know which medicine I'm getting?

It's a 'randomised' study, meaning you won't choose which medicine you get. Also, often in these studies, neither you nor your doctor knows which one you're getting until afterwards, to make it fair.

Is this a new medicine?

No, both Lidocaine and Ropivacaine are established numbing medicines. This study is comparing how well they work for this specific procedure, rather than testing a brand new drug.