Opioid-Free Accelerated Recovery Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative
研究概览
简要总结
To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.
详细描述
All study patients will receive a standardized protocol
- All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center
- Will attempt to minimize the number of anesthesiologists to further control variability in care
Methods:
- Pre-op Optimization
- All patients enroll in education program
- All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure
- Total Joint Procedure
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgeries to be performed at hospital
- •Surgeries to be performed at surgery center
- •Ability to read and understand English
- •Primary care clearance for patients diagnosed with high blood pressure
排除标准
- •Disease states, patient conditions to exclude:
- •Schizophrenia Bipolar Disease Dementia
- •Known allergies to local anesthetics
- •Previous burn to affected extremity
- •BMI > 40
- •Nonoptimized anemia
- •Albumin less than 3.5
- •A1C > 8.0
结局指标
主要结局
Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative
时间窗: 12 weeks
Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols
Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative
时间窗: 12 weeks
The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative
次要结局
- Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity(postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery)
- Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)(Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery)
- Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement(6 weeks)
- Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14(Postop Days10-14)
- Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3(postoperative 3 weeks)
- Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6(Postoperative 6 weeks)
- Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12(Postoperative 12 weeks)
研究者
Dr Andrew B. Wickline
Orthopedic Surgeon
St. Elizabeth Medical Center, Utica, NY