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EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture (RESTORE)

2020年2月25日 更新者:Pacira Pharmaceuticals, Inc

A Phase-4, Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Fascia Iliaca Compartment Block Versus Fascia Iliaca Compartment Block With Continuous Infusion of Ropivacaine Per Standard of Care Through a Catheter in Intertrochanteric Hip Fracture Patients

This study evaluates the effect of EXPAREL on total opioid consumption through 72 hours following fascia iliaca compartment block (FICB) in subjects undergoing repair of intertrochanteric hip fracture.

研究概览

详细说明

The current standard of care treatment for pain relief in patients with intertrochanteric hip fracture is a FICB with continuous infusion of ropivacaine given via catheter.

In this study, some people will receive a single injection FICB with EXPAREL + bupivacaine HCl. The groups will be evaluated to determine the amount of pain medication they took from the FICB to 72 hours after.

研究类型

介入性

阶段

  • 第四阶段

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

    • Ohio
      • Cleveland、Ohio、美国、44195
        • Cleveland Clinic

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

65年 至 85年 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Individuals between 65 and 85 years of age (inclusive of) at screening.
  2. Intertrochanteric femoral fractures with American Society of Anesthesiology physical status 1, 2, or 3.
  3. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

  1. Hip fracture that requires total arthroplasty.
  2. Patients transferred from other hospitals.
  3. Patients that have other acute fractures.
  4. Pre-existing dementia (Mini-Mental State examination score <20) or delirium (Mini-Mental State examination score <24).
  5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, ropivacaine, acetaminophen, NSAIDs).
  6. Serious systemic comorbidities that cause a contraindication for EXPAREL/bupivacaine (severe hepatic or renal impairment) or ropivacaine.
  7. Use of anticoagulants (including aspirin, except low dose aspirin).
  8. Chronic opioid use of ≥ 20 morphine milligram equivalent (MME)/day for more than 7 days in the last 30 days.
  9. Body Mass Index (BMI) <17 kg/m2 or >45 kg/m2.
  10. Known history of renal or hepatic dysfunction, coagulation or bleeding disorder.
  11. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-operative period for pain that is not strictly related to the surgery and which may confound the post-operative assessments based on the physician's discretion.
  12. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study.
  13. History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  14. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study.
  15. Previous participation in an EXPAREL study.
  16. Resident of a skilled nursing facility (SNF), long-term acute care (LTAC) facility, inpatient rehabilitation facility (IRF), or nursing home. Participants from assisted living facilities will be eligible for the study.

    In addition, the subject may be withdrawn from the study if the subject meets the following criteria during the hospital stay:

  17. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's post-operative course.
  18. Subjects who undergo hip fracture surgery more than 30 hours after admission to the Emergency Department.

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:FICB with EXPAREL
Group 1: Suprainguinal Fascia Iliaca Compartment Block (FICB) with EXPAREL and bupivacaine HCl
FICB with EXPAREL + Bupivacaine HCL (single dose)
FICB with EXPAREL + Bupivacaine HCL (Single dose)
有源比较器:FICB with Standard of Care: ropivacaine
Suprainguinal FICB with continuous infusion of local anesthetic (ropivacaine) via catheter placed in the FIC.
FICB with continuous infusion of ropivacaine

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
Primary objective (total opioid consumption in morphine equivalents)
大体时间:Through 72 hours post-FICB
to compare total opioid consumption in morphine equivalents following FICB with EXPAREL +bupivacaine HCl to that following continuous infusion of ropivacaine via catheter, from end of FICB placement through 72 hours post-FICB, in subjects undergoing repair of intertrochanteric hip fracture To be measured as date, time, and dosage of all medication administered from the time ICF is signed to 72-hours post-surgery.
Through 72 hours post-FICB

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。

调查人员

  • 研究主任:Nayana Nagaraj, MD, PhD, MPH、Pacira BioSciences, Inc.

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 (实际的)

2019年8月26日

初级完成 (预期的)

2020年5月1日

研究完成 (预期的)

2020年5月1日

研究注册日期

首次提交

2019年5月14日

首先提交符合 QC 标准的

2019年5月17日

首次发布 (实际的)

2019年5月20日

研究记录更新

最后更新发布 (实际的)

2020年2月27日

上次提交的符合 QC 标准的更新

2020年2月25日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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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