Periarticular Infusion With Liposomal Bupivacaine or a Ropivacaine Cocktail Versus Continuous Femoral Nerve Catheters for Multimodal Pain Management Following Primary TKA: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Time to Discharge Readiness
研究概览
简要总结
The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 40 Years Old
- •Scheduled for Primary Total Knee Arthroplasty
排除标准
- •Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week)
- •Neuromuscular deficit affecting the lower limbs
- •Peripheral neuropathy
- •Radiculopathy/Sciatica
- •Known allergy or intolerance to Bupivacaine or Ropivacaine
- •Hepatic Disease
- •Renal Disease/Patients needing Dialysis
- •Planned unicompartmental knee replacement
- •Less than 90 degree of knee flexion preoperatively.
- •Patients who lack the capacity to consent or are unwilling to do so
- •At the discretion of the PI, patients who may have difficulty complying with standard of care (SOC) followup may also be excluded
研究组 & 干预措施
liposomal bupivacaine (LB) (Exparel)
Mixture of 50 milliliters (mL) of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
干预措施: Exparel (Drug)
Ropivacaine cocktail (PIC)
400 milligrams (mg) Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
干预措施: Ropivacaine cocktail (PIC) (Drug)
continuous femoral nerve blocks (cFNB)
Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.
Sciatic nerve block - 0.125% bupivacaine
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time to Discharge Readiness
时间窗: Participants will be followed for the duration of hospital stay, an average of 3 days
Time to discharge readiness will be defined as the time from surgical stop to the time of the 2nd consecutive assessment where all criteria are fulfilled.
次要结局
未报告次要终点