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RecruitingPHASE4INTERVENTIONAL

Topical TRanexamic Acid vs. Placebo on Acute Postoperative Pain Following DRF Fixation

This research is investigating a common surgery for broken wrists. We want to find out if putting a medicine called tranexamic acid (TXA) directly into the wound during surgery for a broken wrist can help people feel less pain afterwards. The study will compare patients who receive TXA with those who receive a 'placebo' (a dummy treatment, which looks the same but contains no active medicine). We'll be checking if TXA can lead to needing fewer strong painkillers and if it helps people get back to using their wrist more easily following the operation. The aim is to improve how patients recover after surgery for a broken wrist.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
University Health Network, Toronto
Enrolment target
90
Start
13 Aug 2025
Estimated completion
01 Dec 2027

What is this study about?

When you break a bone in your wrist, surgery is often needed to fix it properly. This study is exploring a way to make your recovery after this surgery a bit easier. Specifically, we're looking at a medicine called tranexamic acid (TXA). It's a medicine that's already used in hospitals for different reasons, for example, to help stop bleeding. In this study, we're investigating if applying a small amount of TXA directly into the surgical wound during your wrist operation might help reduce the pain you feel afterwards. We also want to see if it means you'll need fewer pain medications and if it helps you get your wrist moving better more quickly.

To really understand if TXA makes a difference, we need to compare it to not using it at all. That's why some people in the study will receive TXA, and others will receive a 'placebo'. A placebo looks exactly like the TXA but doesn't contain any active medicine. Neither you nor your doctors will know whether you've received the TXA or the placebo, which helps us get unbiased results. This is a common and important way to do research so we can be sure any effects we see are genuinely due to the medicine.

The main goal is to improve how people feel and recover after this common wrist surgery. If TXA proves to be helpful, it could become a new way to manage pain and improve recovery for many people in the future.

Key takeaways

  • This study investigates if a medicine called TXA reduces pain after wrist surgery.
  • TXA will be applied directly to the wound during your operation.
  • You might receive active TXA or a 'placebo' (dummy treatment).
  • The aim is to reduce pain and improve wrist recovery.
  • Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To take part in this study, you would need to be at least 18 years old and be having specific surgery on your wrist for a broken bone. This surgery involves fixing the broken bone using plates or screws through an incision on the palm side of your wrist. You also need to be able to understand the study information and speak English so you can fill out any questionnaires.

However, there are some reasons why you might not be able to join. For example, if you've had previous surgery on the same wrist, or if you have certain long-term pain conditions like fibromyalgia. It's also not suitable if you are already taking strong painkillers (opioids) regularly, or if you have a known allergy to TXA. If you currently have health problems like severe heart or breathing issues, or a history of blood clots, you wouldn't be able to participate. This study also isn't for pregnant or breastfeeding women.

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 18 years old or older?
  2. Are you having surgery for a broken wrist through the palm side of your hand?
  3. Do you not have a history of serious blood clots or severe heart/lung problems?
  4. Are you not currently pregnant or breastfeeding?
  5. Do you not have ongoing long-term pain conditions like fibromyalgia?
  6. Do you not have any known allergies to TXA?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be part of the study for a period after your wrist surgery. This would involve receiving either the active medicine (TXA) or the placebo during your operation. After surgery, you would need to honestly report your pain levels and how much pain relief you're using. You'll likely have follow-up appointments where doctors will check how well your wrist is healing and how much movement you have. You might also be asked to fill out questionnaires about your pain and how you're using your wrist. The total duration of your involvement will be clearly explained to you before you agree to take part.

Potential risks and benefits

Potential benefits of taking part could include better pain control after surgery, needing fewer strong painkillers, and potentially recovering the use of your wrist more quickly. However, there's no guarantee you'll receive the active medicine or experience these benefits. As with any medical treatment, there are potential risks. Though TXA is generally safe, studies like this carefully monitor for any side effects. These will be fully explained to you before you consent to take part. Remember, joining is entirely your choice, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

  • Toronto Western Hospital
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is 'tranexamic acid' (TXA)?

TXA is a medicine that helps reduce bleeding. In this study, we're exploring if it can also help with pain after wrist surgery when applied directly to the wound.

What is a 'placebo'?

A placebo is adummy treatment that looks exactly like the actual medicine but contains no active ingredients. It helps us compare the real medicine's effects accurately.

Will I know if I'm getting the active medicine or the placebo?

No, neither you nor your doctors will know if you've received the active medicine or the placebo. This is to ensure the study results are as fair and unbiased as possible.

How long will I be involved in the study?

The duration of your involvement in the study will be explained in detail by the research team before you agree to participate.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Ryan Paul

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 "Topical TRanexamic Acid vs. Placebo on Acute Postoperative P…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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