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临床试验/NCT04189523
NCT04189523Unknown不适用

Prospective Non-Randomized Interventional Pilot Study of the Effects of Early Administration of Ultrasound Guided Regional Anesthesia for Long Bone Fractures on Long Term Patient Opioid Usage

Wayne State University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
54
试验地点
2
主要终点
Opioids administered for pain control as measured in Morphine Milliequivalents

研究概览

简要总结

Administration of ultrasound guided peripheral nerve blocks is a procedural skill set that falls within the scope of Emergency Medicine practice. Extrapolating evidence from Anesthesia and Orthopedic literature (which shows decreased post-operative opioid use by surgical patients who receive regional anesthesia as part of their pre and perioperative pain management strategy) the investigators believe that early administration of regional anesthesia for long bone fractures by providers in the ED may have an as of yet unidentified positive impact on long term opioid use. If this is indeed found to be the case, early administration of regional anesthesia for extremity fractures would represent an area of focus for ED providers in the national effort by the medical community to combat opioid abuse.

详细描述

The investigators will perform a small prospective non-randomized interventional pilot study to assess feasibility of a future full scale RCT to test the hypotheses. Interventional study subjects will be compared to controls enrolled simultaneously during the study period who meet the inclusion criteria and do not have documentation of one of the exclusion criteria. The investigators will enroll subjects 2 controls to 1 intervention to ensure the ability to select controls as similar to the intervention population as possible. The study is powered for an alpha of 0.9 and an effect size (standardized difference) of 0.2. The total subjects needed to enroll is 36 with 18 subjects in each arm of the study. However, in an attempt to obtain controls as closely matched to our intervention group as possible 36 controls will be enrolled.

A. Subject Selection

Intervention subjects will be enrolled as a convenience sample when physicians participating in the study are available in the ED. Controls will be enrolled when no study participating physicians are available in the ED. Potential subjects will be selected for enrollment by research team members directly from the trauma bay or from the tracking board when they are identified as having a qualifying fracture. They will be screened for exclusion and inclusion criteria by the research assistants. The goal will be to enroll patients within 2 hours of arrival in the ED.

Inclusion Criteria:

  • patients 18 years of age or older
  • presentation to the emergency department with isolated fractures of the hip or proximal femur, mid or distal humerus, radius, or ulna
  • poly-trauma patients with one of the previously listed fractures who do not meet exclusion criteria

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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
否

入选标准

  • •patients 18 years of age or older
  • •presentation to the emergency department with isolated fractures of the hip or proximal femur, mid or distal humerus, radius, or ulna
  • •poly-trauma patients with one of the previously listed fractures who do not meet

排除标准

  • •Exclusion Criteria:
  • •Allergy to Bupivacaine/ropivicaine or other amide anesthetics
  • •evidence of compartment syndrome on exam by physician
  • •infection over injection site
  • •previously documented opioid abuse or dependence in the last year as documented in the EMR or self-reported by the patient
  • •current documented opioid prescription in the EMR
  • •patient is intubated or unable to provide consent
  • •poly-trauma patients with abdominal, thoracic or neurologic injury requiring operative intervention at the time of presentation to the ED

研究组 & 干预措施

Standard of Care Pain Management

Active Comparator

干预措施: SOC Pain Management (Other)

Early Administration of US Guided Nerve Blocks

Experimental

干预措施: Early US Guided Nerve Block Administration (Procedure)

结局指标

主要结局

Opioids administered for pain control as measured in Morphine Milliequivalents

时间窗: 24-hours following injury

Determine if early administration of nerve blocks results in change in morphine milliequivalents (MMEs) required for pain control compared to standard care.

次要结局

  • Opioids administered for pain control as measured in Morphine Milliequivalents(30-days following injury)
  • Opioids administered for pain control as measured in Morphine Milliequivalents(7-days following injury)

研究者

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

Robert Ehrman

Volunteer Faculty

Wayne State University

研究点 (2)

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