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临床试验/NCT02586077
NCT02586077已完成4 期

Foot and Ankle Clinic Application for Liposomal Related Anesthetic

OrthoCarolina Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2014年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Amount of Narcotic Use

研究概览

简要总结

The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.

Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis, hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular arthrodesis
  • Patients over the age of 18
  • The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study

排除标准

  • < 18 years of age
  • Patients with a history of infection
  • Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the arms or legs due to damaged nerves
  • Patients having surgery on both feet at the same time
  • Patients having any other different type of foot and ankle surgery

研究组 & 干预措施

Exparel

Experimental

Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case.

干预措施: Exparel (Drug)

结局指标

主要结局

Amount of Narcotic Use

时间窗: Surgery to post operative day 3

Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.

次要结局

  • Visual Analog Scale of Pain (0-10)(Post anesthesia care unit admission to post operative day 3)
  • Anti-emetic Use(After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3))
  • Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief(Measured at hospital discharge (on post operative day 3))
  • Number of Patients With Post-operative Complications(After surgery to the first scheduled clinic visit, usually 14 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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