RecruitingPHASE2INTERVENTIONAL

Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

This research is exploring if taking Vitamin C around the time of knee replacement surgery can help lower your chances of having ongoing pain afterwards. It's a 'Phase 2' study, which means it's an early step to see if a larger study would be useful. Patients will either receive Vitamin C or a harmless dummy pill (placebo) after their knee surgery. The study is designed to be 'blinded', meaning neither you nor your doctors will know which treatment you are getting. Researchers will follow participants for about a year to see how their pain, mood, and quality of life are affected. The main goal is to check if this idea is worth investigating further on a larger scale.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Health Network, Toronto

Enrolment target

300

Start

16 Apr 2024

Estimated completion

31 Dec 2026

Chronic Pain Knee Pain Chronic Post Operative Pain

What is this study about?

You're probably reading this because you or someone you know is considering knee replacement surgery. This study, called PROVISION, is looking into a really important issue: managing pain after the operation. While knee replacements are very successful for many, some people still experience pain that lasts a long time afterwards. This study wants to find out if taking Vitamin C could be a simple way to help prevent this.

Researchers are using Vitamin C because some studies suggest it might help reduce inflammation and pain. This trial is an early-stage study, meaning it's not meant to give a final answer right away. Instead, it's a 'pilot' study. This means it's testing the waters to see if it's even possible and worthwhile to do a much bigger study on Vitamin C for pain relief after knee surgery in the future. Think of it as a practice run to make sure everything works well before a big performance.

All patients in the study will still receive the standard care for their knee surgery. This study simply adds the Vitamin C or a dummy pill on top of that. The researchers are very careful to make sure you get the best possible care throughout the trial, and your safety is their top priority.

Key takeaways

This study investigates if Vitamin C reduces pain after knee replacement.
It's a pilot study, aiming to see if a larger trial is feasible.
You'll receive either Vitamin C or a dummy pill for 8 weeks.
Neither you nor your doctor will know which treatment you receive.
Participation involves follow-up visits for about one year.
Your involvement could help improve future pain management for others.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and be planning to have a total knee replacement operation, either on one knee or both, because of severe arthritis.

There are some reasons why you wouldn't be able to join. For example, if your knee replacement is for an infection, a broken bone, or certain other conditions like lupus. Also, if you have a history of kidney stones, kidney problems, or certain genetic conditions, you wouldn't be able to take part. This is because Vitamin C might not be suitable for people with these health issues.

The study also needs to make sure participants can complete all the follow-up visits and questionnaires. So, if you're planning to move out of the area, or if language difficulties would make it hard to understand the study, you might not be eligible. Also, if your surgeon feels it's not right for you, or if you're pregnant, planning to become pregnant, or have a milk allergy, you wouldn't be able to join.

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 or older?
Are you having a total knee replacement for arthritis?
Do you have a history of kidney stones or other kidney problems?
Are you able to attend follow-up appointments for a year?
Are you pregnant or planning to become pregnant during the study?
Do you have any allergies to milk products?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups – like flipping a coin. You'll either receive Vitamin C or a harmless dummy pill. You'll take the first dose of your assigned medication within 4 hours before your surgery. Then, starting the day after your surgery, you'll take two doses of either Vitamin C or the dummy pill each day for about 8 weeks.

Throughout the study, both you and the study team won't know whether you're taking Vitamin C or the dummy pill; this is called 'blinded' and helps make the results fair. You'll have several follow-up visits or checks: a few days after surgery, then at 2, 4, 6, and 8 weeks. After that, you'll have two more check-ups at 3 months and 12 months (one year) after your surgery. During these visits, you'll be asked about your pain levels, any other medications you're taking, how well you're sticking to the study medication, any side effects, your mood, and your general quality of life. The total time you'd be involved in the study is about one year.

Potential risks and benefits

By taking part, you might not directly benefit, but you could help researchers understand more about managing pain after knee surgery, which may help future patients. There are always potential risks with any medication, even Vitamin C, and these will be carefully monitored. The dummy pill is harmless. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Sunnybrook - Holland Centre
Verified postcode
Toronto, Canada· Recruiting
Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting
Toronto Western Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is a 'Phase 2' study?

It's an early-stage study to see if a new treatment idea looks promising enough to be tested in a larger, more definitive study.

What is a 'placebo'?

A placebo is a dummy pill that looks just like the real medicine but contains no active ingredient. It helps researchers compare the effects of the active medicine fairly.

Will I know if I'm getting Vitamin C or the dummy pill?

No, neither you nor your doctors will know which you are taking. This is called 'blinded' and helps ensure the study results are unbiased.

How long does the study last?

Your active participation, including follow-up, will be for about one year after your knee surgery.

Can I leave the study early?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

James Khan, MD

james.khan@medportal.ca 416-340-4800 Official trial record

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