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Recruiting NCT06123715

Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

Phase II Interventional Chronic Pain Knee Pain Chronic Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin C, Placebo.
Who it may be relevant to
Registry conditions: Chronic Pain, Knee Pain Chronic, Post Operative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PeRiOperative VItamin C to Reduce perSistent paIn After tOtal kNee Arthroplasty (PROVISION): a Pilot Multicentre Randomized Controlled Trial

Overview

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.

Detailed description

PROVISION is a multicentre, pilot, parallel-group, blinded, randomized controlled trial of 400 patients undergoing total knee arthroplasty surgery. Consented eligible patients will be randomized to receive vitamin C: 2000 mg taken orally within 4 hours of the start of surgery, followed by 500 mg of vitamin C taken twice daily from post-operative day 1 to day 56 (8 weeks). Patient in the control group will receive placebo lactose monohydrate capsules. Study medications will be prepared to look similar and labelled as per regulatory requirements. Patients will follow up on post-operative days 1-3, weeks 2,4,6, and 8 post-operatively, and at 3- and 12-months post-operatively to report on pain, opioid and analgesic consumption, medication adherence, adverse events, functional, mood, and quality of life outcomes.

Interventions

  • Drug Vitamin C
    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 Placebo
    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.

Primary outcome measures

  • Study will determine feasibility of enrolling, recruiting, and follow-up with patients. [Time frame: 12 months]
  • Clinical site compliance [Time frame: 12 months]
  • Resource Assessment [Time frame: 12 months]
Secondary outcome measures (10)
  • Prevalence of persistent pain [Time frame: 3 months and 12 months]
  • Qualities and characteristics of persistent pain [Time frame: 3 months and 12 months]
  • Persistent Neuropathic Pain [Time frame: 3 months and 12 months]
  • Acute and chronic analgesic consumption [Time frame: Day of surgery, post-operative day 1-3, 3 months, and 12 months]
  • Development of Complex Regional Pain Syndrome (CRPS) [Time frame: 3 months and 12 months]
  • Physical function [Time frame: 3 months and 12 months]
  • Emotional functioning [Time frame: 3 months and 12 months]
  • Patient Satisfaction [Time frame: 3 months and 12 months]
  • Quality of life assessment [Time frame: 3 months and 12 months]
  • Adverse events [Time frame: 3 months and 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Canada · 3 centers
  • Sunnybrook - Holland Centre — Toronto
  • Mount Sinai Hospital — Toronto
  • Toronto Western Hospital — Toronto

Identifiers

NCT: NCT06123715 · 23-5642

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗