Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Benefits on Post-operative Pain of Intravenous, Intraoperative, Tranexamic Acid Injection During Arthroscopic Shoulder Surgery.

If you're having shoulder surgery, doctors want to find the best ways to manage your pain afterwards. This study is testing a medicine called tranexamic acid, which is given into a vein during your operation. Researchers believe this medicine might help reduce how much pain you feel, meaning you might need less strong painkillers like morphine in the 24 hours after your surgery. They will also look at how satisfied you are with your pain relief, how well your shoulder recovers over time, and if there are any side effects from the treatment. This research aims to find better ways to make your recovery from shoulder surgery more comfortable.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Aquitaine Sante

Enrolment target

220

Start

07 Jan 2025

Patient requiring shoulder arthroscopy

What is this study about?

This study is about making recovery from shoulder surgery more comfortable for patients. When you have an operation on your shoulder, it's normal to feel some pain afterwards. Doctors are always looking for better ways to help manage this pain. This particular study is focusing on a medicine called tranexamic acid.

Tranexamic acid is given directly into your vein during your shoulder surgery. The main thing the researchers want to find out is if people who receive this medicine need less strong pain medication, like morphine, in the first 24 hours after their operation. This would suggest that the tranexamic acid is helping to reduce their pain.

Beyond just pain medication, the study will also look at other important things. For example, they'll ask about your pain levels a day after surgery and a week later, and how happy you are with your overall experience. They will also check how well your shoulder is moving and working about a month after surgery. As with any medical study, they will carefully watch for any unexpected effects or issues that might come up.

Key takeaways

Researchers are testing a medicine to reduce pain after shoulder surgery.
The medicine (tranexamic acid) is given during the operation.
The main goal is to see if patients need less strong pain medication afterwards.
The study also checks pain levels, satisfaction, and shoulder recovery.
Participation involves monitoring for about one month after surgery.

Who may be eligible?

This study is looking for adults aged 18 or older who are scheduled to have a specific type of shoulder surgery called an arthroscopy. This is a common keyhole surgery often used to diagnose and treat problems inside the shoulder joint.

Both men and women can take part in this study. The most important thing is that you are planning to have this shoulder operation. Your doctor will be able to tell you if your specific surgery fits the requirements for this study.

There might be other health conditions or medicines you are taking that mean you can't join, but the doctors running the study will check all these details carefully with you.

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 to have shoulder arthroscopy (keyhole surgery)?
Are you open to potentially receiving a study medicine or a dummy treatment?
Are you able to complete online assessments and attend follow-up checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, tranexamic acid, or a dummy treatment (a saline solution, which is just salty water) during your shoulder surgery. You won't know which one you're getting, as this helps make the study results fair.

After your surgery, and for the first 24 hours, the study team will carefully track how much pain medication, specifically morphine, you need. You'll also be asked to rate your pain on a simple scale. About a week after your surgery, you'll complete an online assessment about your pain. Around 30 days after your operation, they will check how well your shoulder is moving and working. The study team will also keep track of any side effects you experience throughout your participation. The total duration of your active involvement will be about one month, with monitoring for pain and shoulder function.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the tranexamic acid helps to reduce your pain after surgery, possibly meaning you need less strong painkillers. Everyone in the study will receive excellent care, whether they get the active medicine or the dummy treatment. As with any medicine or procedure, there's always a chance of side effects, which the study team will carefully monitor. You are 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.

—
Unverified
France

Common questions

What exactly is tranexamic acid?

It's a medicine given into your vein during surgery that researchers are investigating to see if it helps reduce pain and bleeding.

Will I know if I'm getting the real medicine or the dummy treatment?

No, neither you nor your doctors will know. This is a standard way to make sure the study results are unbiased and reliable.

What kind of shoulder surgery is this for?

This study is for patients having 'arthroscopic shoulder surgery,' which is a common type of keyhole operation on the shoulder.

How long will I be involved in the study?

You'll be actively involved for about a month after your surgery, with follow-ups for pain and shoulder function assessments.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without giving a reason, and it won't affect your medical care.