Health TrialsbyHealthPanel

Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

ConditionsChronic PainKnee Pain ChronicPost Operative Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients >18 years old

Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vitamin C

    Drug

    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.

  • Placebo

    Drug

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Study will determine feasibility of enrolling, recruiting, and follow-up with patients.

The study will assess the feasibility of enrolling, recruiting, and following-up with patients undergoing a primary total knee arthroplasty (TKA) through active monitoring of recruitment/enrollment rates on a monthly basis for a total of one year using excel trackers. The follow-up rate of patients will be assessed at 12 months based on completion of all 12 month questionnaires.

Time frame
12 months
2

Clinical site compliance

Clinical site compliance with trial protocol will be determined based on number of protocol deviations at each site as logged on the deviation logs. This will be assessed on a monthly basis for a full year to maintain active monitoring of compliance.

Time frame
12 months
3

Resource Assessment

This pilot study will help determine the resources required for larger definitive trial based on critical analysis of recruitment trackers to assess time spent on recruitment/enrollment.

Time frame
12 months

Secondary outcomes

1

Prevalence of persistent pain

Pain intensity measured using 0-10 Numeric Rating Scale (NRS) scale at rest and movement

Time frame
3 months and 12 months
2

Qualities and characteristics of persistent pain

Pain qualities measured using the 0-10 scale of the Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)

Time frame
3 months and 12 months
3

Persistent Neuropathic Pain

Neuropathic pain assessed on a binary scale of Yes or No using the Douleur Neuropathique 4 (DN4) symptoms interview

Time frame
3 months and 12 months
4

Acute and chronic analgesic consumption

Analgesic and oral morphine-equivalent opioid consumption

Time frame
Day of surgery, post-operative day 1-3, 3 months, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

The Arthritis Society, Canada

Collaborator

Source ClinicalTrials.gov
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