Opioid Reduction in Orthopaedic Surgery (OREOS): a Feasibility Randomized Controlled Trial in Knee Replacement Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Participant recruitment [feasibility]
研究概览
简要总结
Knee replacements are the second most common surgery in Canada. Most patients recover very well but research consistently shows that 1 in 5 patients still have pain many months after surgery. Doctors often prescribe opioid medications for pain after surgery (e.g. Percocet, hydromorphone, codeine). These medications can be helpful for some people, but they can also be dangerous, particularly when used for a long time. Many patients don't like the way opioids make them feel and would prefer alternative pain management strategies. Some people become addicted to opioids, have a difficult time reducing the dose of opioids, or have lasting health problems after using them.
People in this study will be randomized to either have usual care or a new pathway designed to improve pain control and decrease opioid use after knee replacements. This study will have an intervention coordinator who will assess patients before surgery and who will follow up with patients regularly after surgery to make sure their pain is controlled and to avoid long-term opioid use. This study will use education, physiotherapy, psychological therapy, ice/cold, and non-opioid pain medications. As pain medications may work differently in different patients, the coordinator will check on each patient to look for pain control and assist to reduce the amount of opioids used after surgery.
This study will help people have safer and more effective pain management after surgery which may lead to better recovery, higher satisfaction, and a lower risk of being harmed by opioids after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the study interventions, patients and the health care team cannot be blinded. An independent blinded surgeon will evaluate each adverse event to minimize the risk of bias for that outcome. The primary study outcome of non-opioid pain control will be collected using a daily e-diary up to 8 weeks. Other study outcomes will be collected by a research personnel not involved in the clinical care. Data analysts will be blinded for all outcomes
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
- •Adult (18+)
- •Undergoing elective total knee arthroplasty (TKA) for knee arthritis
- •Can use a simple electronic (phone or tablet) device
- •Provide informed consent to participate
排除标准
- •Revision surgery
- •Simultaneous bilateral arthroplasties
- •Unable to consent (e.g., cognitive disability or substantial language barrier without a support person)
结局指标
主要结局
Participant recruitment [feasibility]
时间窗: 4 months
Number of participants recruited
Participant retention [feasibility]
时间窗: 8 weeks
Number of participants completing the primary outcome
Intervention adherence [feasibility]
时间窗: 8 weeks
Percentage of patients receiving at least 3 of the 4 trial intervention components.
次要结局
- Opioid-free pain control(8 weeks)
- Chronic post-surgical pain (CPSP)(12 months)
- CPSP intensity of resting and movement evoked pain(12 months)
- Postoperative opioid use(12 months)
- Satisfaction with pain control(12 months)
- Health related quality of life(12 months)
- Complications(12 months)
研究者
Kim Madden
Assistant Professor
McMaster University
