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临床试验/NCT03341104
NCT03341104已完成不适用

Evaluation of Intraoperative, Local Site Injections of Liposomal Bupivacaine as an Alternative to Standard Local Anesthetics in Patients Undergoing Total Hip Arthroplasty

OSF Healthcare System0 个研究点目标入组 173 人开始时间: 2013年1月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
173
主要终点
Comparing physical function of the control group with the experimental group

研究概览

简要总结

This study aims to compare the effectiveness of liposomal bupivacaine (LB) versus standard of practice local injection containing plain bupivacaine.

详细描述

Investigation of liposomal bupivacaine to determine if this drug is a valid alternative to standard of care local anesthesia based on evaluation in total hip arthroplasty This is a retrospective cohort study of consecutive patients undergoing THA at 3 hospitals within a U.S. healthcare system from January 2013 to July 2016. The control group received the standard of care undergoing THA (plain bupivacaine or ropivacaine), while the LB group received a mixture containing this drug as the alternative to the standard care. The outcome variables include hospital length of stay, readmissions, total hospital costs, patient pain scores, discharge disposition, morphine equivalent opioid consumption, and postoperative patient ambulation. Generalized linear models were employed to examine aforementioned outcomes controlling for age, gender, race, BMI, alcohol use, tobacco use, and surgeons..

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Males or females over the age of 18
  • have undergone a THA surgery during the period of interest January 2013 to July 2016).

排除标准

  • excluded from the study based on the following criteria:
  • Concurrent, painful, physical condition or concurrent surgery that may require analgesic treatment in the postoperative period for pain that is not strictly related to the surgical treatment;
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder; and
  • Significant renal or hepatic insufficiency.

结局指标

主要结局

Comparing physical function of the control group with the experimental group

时间窗: 43 months

distance in feet walked

Comparing total hospital costs of the control group with the experimental group

时间窗: 43 months

Number of dollars

Comparing length of stay in acute care facility of the control group with the experimental group

时间窗: 43 months

number of days

次要结局

未报告次要终点

研究者

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

Ed Rainville

Clinical Pharmacy Supervisor

OSF Healthcare System

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