Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

The effect of combining lidocaine and ropivacaine on the duration and onset time of an ultrasound-guided infraclavicular brachial plexus nerve block. A randomized controlled trial

This research study is investigating how a combination of two common local anaesthetics, lidocaine and ropivacaine, performs during hand surgery. The main goal is to find out if mixing these medicines helps the pain relief last longer after an 'infraclavicular brachial plexus nerve block' – that's a way of numbing the arm by targeting nerves in the shoulder area. They also want to see if the numbing effect starts more quickly. This information could help doctors provide better pain control for patients having operations like fixing broken bones in the lower arm or surgery on the thumb joint.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Nordsjaellands Hospital

Enrolment target

Start

22 Mar 2024

Patients undergoing hand surgery for antebrachial fractures or arthroplasty/alloplasty of a thumb base joint in the hand

What is this study about?

This study is looking into a type of pain relief called a 'nerve block' for people having hand surgery. Imagine your arm nerves are like a telephone cable. A nerve block is like putting a temporary 'mute' button on that cable so the pain signals can't get to your brain during surgery. Doctors use a special scan, like an ultrasound, to guide a tiny needle to the right spot in your shoulder area. This allows them to numb your entire arm.

In this study, they're testing two common numbing medicines, lidocaine and ropivacaine, to see if using them together works better than using them separately. They want to find out if this combination makes the numbing effect start quicker, last longer, and also how well it stops you from feeling anything during and after your surgery. This is important for managing pain during and after your operation.

The main thing they want to measure is how long it takes until you first feel any pain in the area of your surgery after the nerve block has been given. They will also look at how quickly your arm goes completely numb, how long that numbness lasts, and for how long you can't move your arm properly. This research could help doctors choose the best way to keep patients comfortable during and after hand surgery.

Key takeaways

Tests a new combination of numbing medicines for hand surgery.
Aims for pain relief that starts faster and lasts longer.
Focuses on patients having specific hand operations.
Uses a common and safe method of local anaesthesia (nerve block).
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, and the study is open to both men and women.

You would be eligible if you are scheduled to have specific types of hand surgery. This includes operations to fix broken bones in your lower arm (often called 'antebrachial fractures').

Additionally, if you are having surgery on your thumb's base joint, either to repair it or replace it with a new one, you could also be included in this 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 having surgery for a broken bone in your forearm?
Or, are you having surgery on the base joint of your thumb (repair or replacement)?
Are you generally healthy enough for surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive one of the specific pain relief combinations during your hand surgery. This would involve a nerve block procedure where medication is injected near the nerves in your shoulder area. Researchers would then carefully monitor how quickly the numbing effect starts and how long it lasts. They'll also check your pain levels. This primarily involves assessments during and immediately after your surgery, with follow-up to see how long the pain relief from the block lasts. The total duration of your participation would be focused around the time of your surgery and the immediate recovery period.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a potentially optimized pain relief combination for your hand surgery. While nerve blocks are generally safe, there are small risks involved, such as minor bruising, infection, or, very rarely, nerve damage. You will be closely monitored, and medical staff will be available to address any concerns. You are always free to withdraw from the study at any time without 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 nerve block?

It's a way to numb a part of your body for surgery by injecting medicine near the nerves that control feeling in that area.

What kind of hand surgery is this for?

It's for surgery to fix broken bones in your forearm or operations on the base joint of your thumb.

What does 'breakthrough pain' mean?

It's the first time you start to feel any pain in the area of your surgery after the nerve block has been fully given.

Will I get both medicines?

The study is comparing different combinations, so you would receive one specific type of pain relief, which might be a mix of the medicines.

Can I leave the study if I change my mind?

Yes, you can absolutely choose to leave the study at any point, and your medical care won't be affected.