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Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

2017年4月26日 更新者:Ryan Plyler、Monmouth Medical Center

A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty

The purpose of this prospective study is to examine the effect of two local anesthetics used in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay. The two agents are bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay.

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

介入性

注册 (预期的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Jersey
      • Long Branch、New Jersey、美国、07740
        • Monmouth Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
有源比较器:Ropivacaine
This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.
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.

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)
The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).
Hospital course (approximately 2-3 days)

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)
The investigators will compare the length of stay between the two groups.
Hospital course (approximately 2-3 days)
Post-Operative Range of Motion
大体时间:Hospital course (approximately 2-3 days)
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.
Hospital course (approximately 2-3 days)
Post-Operative Distance Walked
大体时间:Hospital course (approximately 2-3 days)
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.
Hospital course (approximately 2-3 days)
Amount of Narcotics required
大体时间:Hospital course (approximately 2-3 days)
The investigators will monitor the amount of medication taken by participants during the hospital stay.
Hospital course (approximately 2-3 days)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年1月1日

初级完成 (实际的)

2016年6月1日

研究完成 (预期的)

2017年7月1日

研究注册日期

首次提交

2015年7月27日

首先提交符合 QC 标准的

2015年11月16日

首次发布 (估计)

2015年11月18日

研究记录更新

最后更新发布 (实际的)

2017年4月27日

上次提交的符合 QC 标准的更新

2017年4月26日

最后验证

2017年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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