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
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 4
- 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 exclusion criteria
排除标准
- •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
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)
研究者
Robert Ehrman
Volunteer Faculty
Wayne State University