Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty
PeRiOperative VItamin C to Reduce perSistent paIn After tOtal kNee Arthroplasty (PROVISION): a Pilot Multicentre Randomized Controlled Trial
University Health Network, Toronto
300 participants
Apr 16, 2024
INTERVENTIONAL
Conditions
Summary
Phase II Multicentre, pilot, parallel-group, blinded, 1:1 randomized controlled trial to determine the feasibility of conducting a larger definitive trail of using vitamin C to reduce persistent pain in patients undergoing total knee arthroplasty surgery.
Eligibility
Inclusion Criteria2
- Patients >18 years old
- Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee
Exclusion Criteria8
- 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
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Interventions
Drug: Patients in the intervention group will receive 2g Vitamin C orally within 4 hours of the start of the surgery followed by 500 mg of Vitamin C to be taken orally twice a day from post-op day1 to day 56.
Drug: Patients in the placebo group will receive identical placebo capsules taken orally within 4 hours of the start of the surgery followed by placebo capsules taken orally twice a day from post-op day 1 to day 56.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06123715