Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty
A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty
研究概览
详细说明
Total knee arthroplasty (TKA) is associated with intense early postoperative pain. Effective pain management following total knee arthroplasty is imperative to facilitate early ambulation, mobilization and rehabilitation. The postoperative pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. To manage postoperative pain effectively, multimodal analgesia including acetaminophen, Toradol, Solu-Medrol, opioids and local anesthetics are used. Periarticular infiltration performed intra-operatively combined with ultrasound guided adductor-canal peripheral nerve blocks are effective in reducing pain following a TKA without causing quadriceps motor block which can impede mobilization. There are no published trials that the investigators could find to date, comparing adductor canal block with a single dose Exparel and adductor canal block with standard ropivacaine.
A liposome is a manufactured spherical lipid vesicle that can be used to slowly release a drug thereby extending its duration of action. Exparel is such a compound that slowly releases bupivacaine. Local anesthetics block the conduction of all excitable tissue in a dose related fashion. The first tissues that are affected are nerves, which make these drugs of choice in neural block. Their local adverse effects include neurovascular manifestations are prolonged numbness, tingling, feeling of "pins and needles" or strange sensations. These effects are reversed with time. There are no additional potential risks or adverse effects due to the procedures or drugs being administered. The procedure is well established and the local anesthetics have a history of long term use in humans.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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New Jersey
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Long Branch、New Jersey、美国、07740
- Monmouth Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.
Exclusion Criteria:
- Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Ropivacaine
This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.
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实验性的:Exparel
This group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pain relief
大体时间:Hospital course (approximately 2-3 days)
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The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).
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Hospital course (approximately 2-3 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Length of stay
大体时间:Hospital course (approximately 2-3 days)
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The investigators will compare the length of stay between the two groups.
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Hospital course (approximately 2-3 days)
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Post-Operative Range of Motion
大体时间:Hospital course (approximately 2-3 days)
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The investigators will compare the range of motion between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.
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Hospital course (approximately 2-3 days)
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Post-Operative Distance Walked
大体时间:Hospital course (approximately 2-3 days)
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The investigators will compare the distance walked between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.
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Hospital course (approximately 2-3 days)
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Amount of Narcotics required
大体时间:Hospital course (approximately 2-3 days)
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The investigators will monitor the amount of medication taken by participants during the hospital stay.
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Hospital course (approximately 2-3 days)
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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