AuthorisedTherapeutic confirmatory (Phase III)Interventional

Phase III Randomized, Double-Blind Clinical Trial to Determine the Role of Magnesium Sulfate in Adductor Canal Block in Total Knee Arthroplasty

This research is a big study (Phase III) to find out if a substance called magnesium sulfate, when added to a common pain-relief injection (an adductor canal block) during knee replacement surgery, can help manage pain better. An adductor canal block is an injection that numbs the nerves going to the knee, helping with pain after the operation. The study wants to see if adding magnesium sulfate makes this pain relief last longer, so patients might not need extra pain medication as quickly. Half the participants will get the magnesium sulfate with the pain reliever, and the other half will get a dummy liquid (saline) with the pain reliever, without anyone knowing which they're getting. Finding better ways to manage pain after surgery is important for recovery.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Progreso Y Salud

Enrolment target

131

Start

14 Oct 2024

Total knee arthroplasty

What is this study about?

Imagine you're having knee replacement surgery. To help with pain afterwards, doctors often use a special injection called an 'adductor canal block'. This injection numbs the nerves that send pain signals from your knee to your brain, making you much more comfortable as you recover. Think of it like turning down the volume on pain in your knee area.

This study is testing if we can make that pain-relieving injection even better. Researchers are exploring if adding a common substance, magnesium sulfate (often called Epsom salts), to the usual pain medicine in the block can make the pain relief last for a longer time. If the pain relief lasts longer, you might not feel the need for other strong painkillers as quickly, which could help your recovery and comfort. This is a "Phase III" study, which means it's a large, important step to confirm if this new approach really works and is safe.

To make sure the results are fair, some people in the study will get the magnesium sulfate with their pain-blocking injection, and others will get the same pain-blocking injection with a harmless salt solution (like sterile water) instead of magnesium sulfate. Neither you nor your doctor will know which one you're getting. Doctors will then carefully watch how long it takes before you feel you need more pain medication. This helps them understand if magnesium sulfate truly extends the pain relief.

Key takeaways

The study explores if magnesium sulfate makes pain relief after knee surgery last longer.
It uses a common pain-blocking injection called an adductor canal block.
Half of participants get magnesium, half get a dummy liquid; neither you nor your doctor will know which.
The main goal is to see how long pain relief lasts before more painkillers are needed.
This is a large, important study (Phase III) to help improve future pain management.

Who may be eligible?

This study is looking for adults who are planning to have a total knee replacement operation. To be considered, you must be at least 18 years old. There's no upper age limit, so people of all adult ages can take part. Both men and women are welcome to participate in this research.

Essentially, if you are an adult, regardless of your specific age or gender, and are scheduled for a complete knee replacement procedure, you might be able to join this study. The medical team will check other details from your health history to make sure the study is a safe and good fit for 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 planning to have total knee replacement surgery?
Are you comfortable with the idea of receiving an injection for pain relief?
Are you willing to have your pain levels monitored after surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve receiving a standard pain-blocking injection (an adductor canal block) as part of your knee replacement surgery. In addition to the usual pain medicine, you would either receive magnesium sulfate or a simple salt solution in this injection. After your surgery, the medical team will carefully monitor how long it takes before you feel you need extra pain medication. There will be no extra hospital visits beyond your normal surgical care. The total duration of your participation will mainly cover your time in the hospital immediately after surgery, up until you first request pain relief.

Potential risks and benefits

Participating in this study might offer an improved way to manage pain after your knee replacement, potentially making your initial recovery more comfortable. However, there's also a chance that the magnesium sulfate won't extend pain relief, or that you might feel some mild, temporary side effects from the injection, similar to any medical procedure. Serious side effects are rare. It's very important to remember that joining a study is always your choice, and you have the right to withdraw at any time, even after you've started, 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
Spain

Common questions

What is an adductor canal block?

It's an injection near your thigh that numbs nerves going to your knee, helping to reduce pain after surgery.

What is magnesium sulfate?

It's a common mineral salt, sometimes called Epsom salts, that researchers think might help pain relief last longer.

Will I know if I'm getting the magnesium or the dummy liquid?

No, neither you nor your doctors will know, so the study results are unbiased and fair.

Is this a new or experimental medicine?

Magnesium sulfate is well-known, but we are testing if adding it to this specific pain block improves its effects for knee surgery.

How long will I be in the study?

Your participation mainly covers your hospital stay after surgery, up until you ask for extra pain medication for the first time.