Femoral Versus Adductor Canal Continuous Peripheral Nerve Blocks for Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Hours Until Discharge Readiness
研究概览
简要总结
Patients typically experience moderate-to-severe pain following knee arthroplasty that is usually treated with a combination of oral and intravenous analgesics and enhanced by continuous peripheral nerve blocks. There are currently two locations to place a perineural catheter to provide analgesia following knee arthroplasty: a femoral nerve catheter and an adductor canal catheter. Both have been demonstrated to be effective following knee arthroplasty. However, it remains unknown if one location is superior to the other; or, more accurately, what the relative benefits are to each technique.
While femoral CPNB has many benefits, one of the challenges of using this technique is that there is a decrease in quadriceps muscle strength which can be a limiting factor for rehabilitation. In contrast, the adductor canal catheter affects only the vastus medialis. This block may lessen block-induced quadriceps weakness following knee arthroplasty compared with a femoral infusion.
The investigators hypothesize that compared with femoral perineural local anesthetic infusion, an adductor canal infusion is associated with a shorter time until four discharge criteria are met: (1) adequate analgesia; (2) independence from intravenous analgesics; (3) ability to ambulate 30 m; and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.
详细描述
Of importance: The primary investigation involves 80 evaluable subjects (with primary endpoint data) having tri-compartment knee arthroplasty. In addition, the investigators will enroll up to 70 subjects having uni-compartment knee arthroplasty as a pilot study in preparation for a subsequent larger, definitive trial. These two groups will not be analyzed together--they represent two distinct studies: one a definitive RCT for tri-compartment knee arthroplasty; and, one a pilot study for uni-compartment knee arthroplasty.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary, unilateral knee arthroplasty
- •age ≥ 18 years
- •postoperative analgesic plan includes perineural local anesthetic infusion of 48-72 hours
排除标准
- •morbid obesity as defined by a body mass index >40 (BMI=weight in kg/ [height in meters]
- •chronic, high-dose opioid use (greater than 20mg oxycodone-equivalent opioid use daily within the 2 weeks prior to surgery and duration of use >4 weeks)
- •history of opioid abuse
- •allergy to study medications
- •known renal insufficiency (creatinine > 1.5 mg/dL)
- •incarceration
- •any known neuro-muscular deficit of the ipsilateral femoral nerve, obturator nerve and/or quadriceps muscle (including diabetic peripheral neuropathy); and inability to ambulate 30 m preoperatively.
结局指标
主要结局
Hours Until Discharge Readiness
时间窗: 7 postoperative days
Discharge readiness is the number of hours until meeting the following 4 criteria: (1) adequate analgesia (defined as pain less than 4 on a NRS of 0-10); (2) independence from intravenous analgesics; (3) ability to ambulate 30 m and (4) ability to stand, walk 3 m, and return to a sitting position without another's assistance.
次要结局
- Time Until Ambulation at Least 30 Meters(7 postoperative days)
- Time Until Timed Up and Go Test Achieved(Hours)
- Time to Adequate Analgesia(First 7 postoperative days)
- Opioid Consumption(Postoperative Days 0-3)
- Time Until Independence From Intravenous Analgesics of at Least 12 Hours(First 7 postoperative days)
- Pain Level(Postoperative Days 1-3)
研究者
Brian M. Ilfeld, MD, MS
Professor of Anesthesiology
University of California, San Diego