Using vitamin C to reduce pain after knee surgery
PeRiOperative VItamin C to Reduce perSistent paIn After tOtal kNee Arthroplasty (PROVISION): a Pilot Multicentre Randomized Controlled Trial
This study is testing if giving vitamin C to people before and after knee surgery can help reduce their pain and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 3 sites (Toronto, Ontario and 2 other locations) |
| Trial ID | NCT06123715 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the feasibility of using vitamin C to alleviate persistent pain in patients undergoing total knee arthroplasty. A total of 300 patients will be randomly assigned to receive either vitamin C or a placebo, with the vitamin C administered shortly before surgery and continued for eight weeks post-operatively. Participants will be monitored for pain levels, medication use, and quality of life at various follow-up points. The study aims to gather preliminary data to support a larger definitive trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing primary total knee arthroplasty for advanced osteoarthritis.
Not a fit: Patients with specific contraindications such as infections, certain autoimmune diseases, or those with a history of kidney stones may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic pain following knee surgery, improving recovery and quality of life for patients.
How similar studies have performed: While the use of vitamin C in this context is novel, other studies have explored its effects on pain management with varying results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients \>18 years old * Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee Exclusion Criteria: * TKA for infection (septic joint), 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 impede valid completion of questionnaires * Planned staged bilateral TKA * Treating surgeon deems patient inappropriate for inclusion in trial * Any allergy or sensitivity to milk * Pregnant or planning to become pregnant during the study
Where this trial is running
Toronto, Ontario and 2 other locations
- Sunnybrook - Holland Centre — Toronto, Ontario, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- Toronto Western Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: James Khan, MD — University Health Network; Department of Anesthesia and Pain Medicine
- Study coordinator: James Khan, MD
- Email: James.Khan@medportal.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.