Two-arm, Double-blind Randomized Study Comparing Exparel and Exparel Plus an Adductor Canal Block in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pain as assessed by Visual Analog Scale (VAS)
研究概览
简要总结
Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 80 years at the time of surgery.
- •Willing and able to give voluntary informed consent to participate in this investigation.
- •Candidate for total knee arthroplasty.
- •BMI < 35.
排除标准
- •Subject has had previous arthroplasty or fracture procedure(s) on the operative knee.
- •Creatine level ≥ 1.5
- •Pre-existing gait disturbance or neuropathy.
- •Allergy to local anesthetics.
- •Inflammatory arthropathies.
- •Female patient who is pregnant or nursing.
- •Chronic use of narcotics
- •Any other reason (in the judgment of the investigator).
研究组 & 干预措施
Exparel plus Adductor Canal Block
Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
干预措施: Liposomal bupivacaine (Drug)
Exparel plus Adductor Canal Block
Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
干预措施: Ropivacaine (Drug)
Exparel plus Adductor Canal Block
Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
干预措施: Epinephrine (Drug)
Exparel plus Adductor Canal Block
Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine
干预措施: Clonidine (Drug)
Exparel plus Placebo Block
Adductor canal block with 20 cc saline
干预措施: Liposomal bupivacaine (Drug)
Exparel plus Placebo Block
Adductor canal block with 20 cc saline
干预措施: Saline (Drug)
结局指标
主要结局
Pain as assessed by Visual Analog Scale (VAS)
时间窗: 12 Months
Pain, as assessed by Visual Analog Scale (VAS)
次要结局
- Function as assessed by Knee Society Score (KSS) and EQ-5D(12 Months)
- Opioid consumption as assessed by dosage and frequency of narcotic usage(30 hours)