Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Undergoing unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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
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
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
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