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NCT Number: NCT06123715

Perioperative Vitamin C to Reduce Persistent Pain After Total Knee Arthroplasty

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.

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Key information

Conditions

Chronic Pain Knee Pain Chronic Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Pain Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Ascorbic Acid

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.

Other names: Lactose (Monohydrate)

Primary outcomes

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

    Time frame: 12 months

    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.

  2. Clinical site compliance

    Time frame: 12 months

    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.

  3. Resource Assessment

    Time frame: 12 months

    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.

Secondary outcomes

  1. Prevalence of persistent pain

    Time frame: 3 months and 12 months

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

  2. Qualities and characteristics of persistent pain

    Time frame: 3 months and 12 months

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

  3. Persistent Neuropathic Pain

    Time frame: 3 months and 12 months

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

  4. Acute and chronic analgesic consumption

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

    Analgesic and oral morphine-equivalent opioid consumption

  5. Development of Complex Regional Pain Syndrome (CRPS)

    Time frame: 3 months and 12 months

    Presence of CRPS measured by a physical assessment of sensory, vasomotor, sudomotor/edema, and motor/tropic categories using the Budapest Criteria

  6. Physical function

    Time frame: 3 months and 12 months

    Patient reported outcome measure to assess level of function, daily living activities and their affect on pain measured by answering 12 questions using the Oxford Knee Score (OKS)

  7. Emotional functioning

    Time frame: 3 months and 12 months

    Patients emotional functioning measured on a scale of 1-5 using the EQ-5D-5L

  8. Patient Satisfaction

    Time frame: 3 months and 12 months

    Assessment of patient satisfaction with surgery on scale of 0-100

  9. Quality of life assessment

    Time frame: 3 months and 12 months

    Patient reported assessment of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a scale of level 1 - level 5 using the EuroQol 5-dimension 5-level (EQ-5D-5L)

  10. Adverse events

    Time frame: 3 months and 12 months

    Monitored as a secondary safety outcome using an assessment of follow-up visits for drug related adverse events and passive surveillance of clinical notes

Study contacts

Contact information is provided by the study sponsor or research team.

James Khan, MD

CONTACT

[email protected]

416-340-4800 ext. 3243

Nour Ayach

CONTACT

[email protected]

(416) 340 4800 ext. 4221

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • The Arthritis Society, Canada

Registry information

Official study title

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

Acronym: PROVISION

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 9, 2023
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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