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临床试验/NCT02607579
NCT02607579Unknown不适用

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

Monmouth Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Pain relief

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.

排除标准

  • Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery

研究组 & 干预措施

Ropivacaine

Active Comparator

This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.

干预措施: Ropivacaine (Drug)

Exparel

Experimental

This group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.

干预措施: Exparel (Drug)

结局指标

主要结局

Pain relief

时间窗: 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).

次要结局

  • Length of stay(Hospital course (approximately 2-3 days))
  • Post-Operative Range of Motion(Hospital course (approximately 2-3 days))
  • Post-Operative Distance Walked(Hospital course (approximately 2-3 days))
  • Amount of Narcotics required(Hospital course (approximately 2-3 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Plyler

Orthopaedic Surgeon/ Researcher

Monmouth Medical Center

研究点 (1)

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