Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06123715

Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty A Pilot Multicentre Randomized Controlled Trial

Led by University Health Network, Toronto · Updated on 2025-04-25

300

Participants Needed

3

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a Phase II multicentre, pilot, randomized controlled trial to see if vitamin C can reduce ongoing pain in patients having total knee arthroplasty surgery. The study aims to check if a larger trial is feasible by enrolling 300 patients and comparing vitamin C to a placebo. The trial evaluates pain levels, medication use, mood, function, and quality of life after surgery. Participants will be randomly assigned to receive either vitamin C or placebo capsules. The vitamin C group takes 2000 mg orally within 4 hours before surgery, then 500 mg twice daily from day 1 after surgery through day 56 (8 weeks). The placebo group takes identical capsules on the same schedule. The study medications are prepared to look the same and labeled according to regulations. Follow-up visits occur on post-operative days 1-3, weeks 2, 4, 6, and 8, plus 3- and 12-month visits. During the trial, participants report pain, opioid and analgesic use, medication adherence, adverse events, functional ability, mood, and quality of life. Researchers assess feasibility of recruitment, site compliance, and resources over 12 months. Secondary outcomes include persistent pain characteristics, neuropathic pain, development of complex regional pain syndrome, physical and emotional function, patient satisfaction, and safety. The total participation period includes up to 12 months of follow-up.

CONDITIONS

Brief Title

Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients older than 18 years
  • Undergoing unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee
Not Eligible

You will not qualify if you...

  • Total knee arthroplasty for infection, fracture, ankylosing spondylitis, lupus, or psoriatic arthritis
  • History of kidney stones, acute or chronic renal failure, hemochromatosis, or glucose-6-phosphate deficiency
  • Unlikely to comply with follow-up (e.g., no fixed address, plans to move out of town)
  • Language difficulties that would prevent valid completion of questionnaires
  • Planned staged bilateral total knee arthroplasty
  • Treating surgeon deems patient inappropriate for trial inclusion
  • Allergy or sensitivity to milk
  • Pregnant or planning to become pregnant during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Treatment

Duration - 8 weeks

Participants receive vitamin C or placebo capsules starting within 4 hours of surgery and continue twice daily from post-operative day 1 to day 56 (8 weeks).

Daily medication with follow-up visits on post-operative days 1-3, and weeks 2, 4, 6, and 8

Follow-up

Duration - Up to 12 months post-surgery

Participants are followed up to assess pain, medication use, adverse events, and quality of life outcomes.

Visits at 3 months and 12 months post-operatively

Trial Site Locations

Total: 3 locations

1

Sunnybrook - Holland Centre

Toronto, Ontario, Canada, M4Y 1H1

Actively Recruiting

2

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G 1X5

Actively Recruiting

3

Toronto Western Hospital

Toronto, Ontario, Canada, M5T 2S8

Actively Recruiting

Loading map...

Research Team

J

James Khan, MD

N

Nour Ayach

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

POPSICLE (Postoperative Pain Study in Children) A Longitudin...

Chronic Pain

Actively Recruiting

16 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here