Non-Opioid Prescriptions After Arthroscopic Surgery in Canada (NO PAin): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Total oral morphine equivalents (OMEs)
研究概览
简要总结
This is a randomized controlled trial of 200 patients between the ages of 18 and 65 years undergoing outpatient knee or shoulder arthroscopy. Patients will be evaluated clinically at 2 and 6 weeks post-operatively. Patients will be recruited from experienced arthroscopic surgeons at 3 hospital sites in Hamilton, Ontario. All research will be conducted according to international standards of Good Clinical Practice and institutional research policies and procedures.
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
Given that patients in the intervention group will receive a pamphlet explaining how to use their prescription allocation, patient blinding is not feasible. Surgeons cannot be blinded as they will need to sign the prescriptions and provide any necessary advice about the medications being prescribed. Outcome assessors and data analysts will be blinded.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing outpatient knee or shoulder arthroscopy for any of the following procedures: ACL reconstruction (with or without LET), MPFL reconstruction (not including TTO), Chondroplasty, Meniscectomy, Meniscal repair Meniscal transplant, Microfracture, ACI, Fixation of unstable osteochondral lesion, Subacromial decompression, Rotator cuff repair, Shoulder stabilization, Superior capsule reconstruction, Biceps tenotomy/tenodesis, Capsular release, SLAP repair, Diagnostic arthroscopy, Irrigation and/or debridement, Loose body removal, Synovectomy
- •Patients aged 18 years and older
- •Patients who have the ability to speak, understand, and read English
- •Provision of informed consent
排除标准
- •Patients who take or are on a home dose of an opioid medication (i.e. once daily or more)
- •Patients involved in ongoing litigation or compensation claims for any injury (e.g. Work Safety Insurance Board, WSIB)
- •Patients involved in another research study that requires a specific post-operative pain control medication regimen
- •Patients undergoing a knee or shoulder arthroscopy procedure that will likely have an operative time greater than 3 hours
- •Patients who will undergo concomitant open surgery
- •Patients who require overnight admission
- •Patients with a contraindication or allergy to NSAIDs, acetaminophen, or morphine and hydromorphone
- •Patients diagnosed with renal disease or cardiac disease
- •Patients who are scheduled for/plan to have an additional surgical procedure during the 6-week follow-up period
- •Patients who will likely have problems, in the judgement of the investigator, with maintaining follow-up
- •Any other reason(s) the investigator feels is relevant for excluding the patient
结局指标
主要结局
Total oral morphine equivalents (OMEs)
时间窗: 6 weeks postoperatively
The primary outcome is the number of total OMEs consumed as determined by a patient-reported medication diary.
次要结局
- Opioid Refills(6 weeks postoperatively)
- OMEs Prescribed(6 weeks postoperatively)
- Adverse Events(6 weeks postoperatively)
- Patient Satisfaction (Hospital Consumer Assessment of Health Care Provider and Systems Question, HCAHPS)(6 weeks postoperatively)
- Pain (Visual Analogue Scale, VAS)(6 weeks postoperatively)
研究者
Olufemi Ayeni
Professor
McMaster University