PeRiOperative VItamin C to Reduce perSistent paIn After tOtal kNee Arthroplasty (PROVISION): a Pilot Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Resource Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 years old
- •Undergoing a unilateral or bilateral primary total knee arthroplasty for advanced osteoarthritis of the knee
排除标准
- •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
研究组 & 干预措施
Placebo
Preoperative placebo capsules
干预措施: Placebo (Drug)
Intervention
Preoperative Vitamin C capsules
干预措施: Vitamin C (Drug)
结局指标
主要结局
Resource Assessment
时间窗: 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.
Study will determine feasibility of enrolling, recruiting, and follow-up with patients.
时间窗: 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.
Clinical site compliance
时间窗: 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.
次要结局
- Prevalence of persistent pain(3 months and 12 months)
- Persistent Neuropathic Pain(3 months and 12 months)
- Physical function(3 months and 12 months)
- Adverse events(3 months and 12 months)
- Qualities and characteristics of persistent pain(3 months and 12 months)
- Acute and chronic analgesic consumption(Day of surgery, post-operative day 1-3, 3 months, and 12 months)
- Development of Complex Regional Pain Syndrome (CRPS)(3 months and 12 months)
- Emotional functioning(3 months and 12 months)
- Patient Satisfaction(3 months and 12 months)
- Quality of life assessment(3 months and 12 months)