Clinical trial NCT06123715: Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty
Official title: PeRiOperative VItamin C to Reduce perSistent paIn After tOtal kNee Arthroplasty (PROVISION): a Pilot Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Pain
Knee Pain Chronic
Post Operative Pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Arthritis Society, Canada
First posted: 2023-11-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: PROVISION is a multicentre, pilot, parallel-group, blinded, randomized controlled trial of 300 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.

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

Primary outcomes:
measure: Study will determine feasibility of enrolling, recruiting, and follow-up with patients.
timeFrame: 12 months
measure: Clinical site compliance
timeFrame: 12 months
measure: Resource Assessment
timeFrame: 12 months
Secondary outcomes:
measure: Prevalence of persistent pain
timeFrame: 3 months and 12 months
measure: Qualities and characteristics of persistent pain
timeFrame: 3 months and 12 months
measure: Persistent Neuropathic Pain
timeFrame: 3 months and 12 months
measure: Acute and chronic analgesic consumption
timeFrame: Day of surgery, post-operative day 1-3, 3 months, and 12 months
measure: Development of Complex Regional Pain Syndrome (CRPS)
timeFrame: 3 months and 12 months
measure: Physical function
timeFrame: 3 months and 12 months
measure: Emotional functioning
timeFrame: 3 months and 12 months
measure: Patient Satisfaction
timeFrame: 3 months and 12 months
measure: Quality of life assessment
timeFrame: 3 months and 12 months
measure: Adverse events
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook - Holland Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network; Department of Anesthesia and Pain Medicine
name: James Khan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Holland Orthopedic and Arthritic Centre
name: Raman Mundi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Holland Orthopedic and Arthritic Centre
name: Harman Chaudhry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Hospital; Department of Surgery
name: Jesse Wolfstadt, MD
role: PRINCIPAL_INVESTIGATOR
References: