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RecruitingPHASE2INTERVENTIONAL

A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guided Infraclavicular Block

This study aims to discover the best dose of a medicine called dexmedetomidine, which is used alongside local anaesthetic for arm and hand surgery. When you have surgery, doctors can give you a nerve block to numb the area and reduce pain afterwards. We're testing three different amounts of dexmedetomidine (0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg) to see if one dose makes the numbing effect last longer, particularly for how long you can't move your hand and fingers. The study team thinks a slightly higher dose might work a bit longer, helping you stay comfortable for more time after your operation.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrolment target
69
Start
28 Dec 2025
Estimated completion
30 Jun 2026

What is this study about?

This study is designed to help us understand how to make nerve blocks for arm and hand surgery more effective. A nerve block is a way to numb a specific area of your body, like your arm, by injecting medicine near the nerves. This can help with pain during and after surgery. In this study, we're focusing on a specific type of nerve block for the arm, called an infraclavicular brachial plexus block.

We are looking at a medicine called dexmedetomidine, which isn't a painkiller on its own, but it can make other pain-numbing medicines work better and last longer. We want to find the best amount of dexmedetomidine to use with the standard numbing medicines. We're comparing three different doses (0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg) to see if one dose helps the numbing effect, specifically for muscle movement in your hand and fingers, last for a longer time after your operation.

By carefully comparing these different doses, we hope to find a way to improve pain management for people having arm or hand surgery. This could mean you experience less pain for longer after your operation, potentially reducing the need for other painkillers. The study is particularly interested in how long the feeling of numbness, affecting movement, lasts.

Key takeaways

  • Tests different doses of a medicine (dexmedetomidine) for arm nerve blocks.
  • Aims to make pain relief last longer after arm and hand surgery.
  • Compares three specific doses to find the most effective one.
  • Measures how long the numbing effect on hand and finger movement lasts.
  • Participation involves one injection before surgery and a follow-up about numbness duration.
  • Could lead to better pain management for future patients.

Who may be eligible?

To join this study, you would need to be having surgery on your arm, specifically at or below the elbow. You should be between 18 and 75 years old and generally in good health, as assessed by a doctor, with a body mass index (BMI) between 18 and 35.

There are some reasons why you couldn't take part. These include if you can't give your own consent, have ever had an allergic reaction to dexmedetomidine or the numbing medicines used, or have recently received dexmedetomidine. Also, if you have certain existing health conditions like nerve problems, issues with blood clotting, kidney or liver failure, or if you are pregnant or breastfeeding, you wouldn't be able to join. If you've had previous surgery in the area near your collarbone or have ongoing pain issues that require regular strong painkillers, you also wouldn't be suitable.

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.

  1. Are you having surgery on your arm, at or below the elbow?
  2. Are you between 18 and 75 years old?
  3. Do you have good general health (no major heart, lung, kidney, or liver problems)?
  4. Have you had any allergies to numbing medicines or similar drugs before?
  5. Are you pregnant or breastfeeding?
  6. Do you have a pre-existing nerve problem or issues with blood clotting?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first meet with a study team member the day before your surgery. On the day of your surgery, before your operation begins and while you're in an induction room, you will have the nerve block performed. This involves an injection near your collarbone using ultrasound guidance, which helps the doctor see exactly where to inject. The injection will include standard numbing medicines blended with one of the three different doses of dexmedetomidine, chosen randomly (like drawing a number out of a hat).

Immediately after the injection, the doctors performing the block won't know which dose you received. You will be given a simple form to fill out at home. On this form, you'll note down when you feel you can move your hand and fingers fully again. The day after your surgery, a study team member will collect this form from you in person (if you're in hospital) or by phone (if you've gone home). This follow-up ensures we collect important information about how long the numbing effect lasted for you.

Potential risks and benefits

Taking part in this study could potentially mean your nerve block lasts longer, providing you with better pain relief after your arm surgery. As with any medical procedure, there are always some risks involved, such as potential side effects from the medicines or very rare complications from the nerve block itself, but the team will take every precaution. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • McGill University Health Centre
    Verified postcode
    Montreal, Canada· Recruiting

Common questions

What is a nerve block for arm surgery?

It's an injection that numbs your arm to help with pain during and after surgery, similar to how a dentist numbs your mouth.

What is dexmedetomidine?

It's a medication used alongside numbing drugs to help their effects last longer, improving pain relief.

Will I know which dose I'm getting?

No, you won't know which specific dose of dexmedetomidine you receive. This helps ensure the study results are fair and unbiased.

What is the main thing the study wants to find out?

The study wants to see which dose of dexmedetomidine helps the numbness, particularly the inability to move your hand and fingers, last the longest after surgery.

How long will the numbness last?

The study is designed to measure this, but we hope the dexmedetomidine will extend the numbing effect beyond what the standard pain medication alone would provide.

How to find out more

Julián Aliste, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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