Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
研究概览
简要总结
The primary objective of investigators' proposed study is to demonstrate that the following two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS) scores up to 3 months post-operatively: one that is administered a modified multimodal analgesic pathway without opioids and the other administered the current standard multimodal analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The secondary objective is to demonstrate that these cohorts will also have equivalent functional outcomes as determined by both objective measures (such as hip range of motion) and patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all ages with end-stage primary hip osteoarthritis.
排除标准
- •Patients with creatinine clearance between 30 and 60 mL/min
- •Use of any opioid analgesics in the 6 months preceding surgery
- •Revision total hip arthroplasty
- •Patients with liver insufficiency
- •Patients on chronic anticoagulation
- •Workers compensation patients
- •Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)
结局指标
主要结局
Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
时间窗: From immediate post-operative period to 3 months post-operatively
Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt
次要结局
- Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)(From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively)
- Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale(From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively)