Comparison of Ultrasound Guided Femoral Nerve Blockade and Standard Parenteral Opioid Pain Management Alone in Patients With Hip Fracture in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- pain intensity reduction
研究概览
简要总结
The goal of the study is to evaluate whether pain control achieved by Ultrasound Guided Femoral Nerve Blockade (USFNB) is equal in efficacy to standard pain management practice of parenteral injection of opioid pain medication in patients presenting to the emergency department (ED) with hip fracture.
详细描述
In this proposed protocol the investigators will conduct a prospective, randomized control trial comparing the efficacy of Ultrasound Guided Femoral Nerve Blockade (USFNB) versus the standard of care pain management by parenteral injection of opioid pain medication of patients presenting with hip fracture at the BIDMC ED. We hypothesize that USNFB approach will be non-inferior in achieving pain control (efficacy) and superior in the total dose of opioids (lower amount) as compared to the standard protocol. The enrolled population will be randomized 1:1 using a simple balanced randomization scheme.
Participants will be surveyed six times 6 times on a Visual Analog Scale (VAS)* on their pain intensity reduction over 4 hours.
Physicians performing the block will be surveyed promptly following the procedure regarding difficulty performing the block and its efficacy.
Specific Aim #1: The investigators hypothesize that in patients presenting to the ED with hip fracture, USFNB will demonstrate equal efficacy in pain relief with fewer side effects when compared to conventional parenteral opioid therapy. The investigators evaluate this hypothesis by monitoring Visual Analogue Scales (VAS) in patients receiving either USGFNB or opioid therapy over the first 4 hours of observation. The side effects will be noted during the same interval of time.
Specific Aim #2: The investigators hypothesize that in patients presenting to the ED with hip fracture, USFNB will reduce the amount of narcotic used to control pain. The investigators will evaluate this by studying narcotic use over the first 4 hours of evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 101 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age presenting to the ED with radiographically established intra-, extracapsular hip fracture, able to consent and participate in the study and who have moderate to severe pain (numerical pain score >= 31) at the time of enrollment.
排除标准
- •Patients with a previous history of hypersensitivity to local anesthetics,
- •Patients who have signs of a local infection at the site of planned needle placement.
- •INR > 1.4NOAC use within 48 hours
- •Prophylactic Low-Molecular Weight Heparin (LMWH) within 12 hours
- •Therapeutic LMWH within 24 hours
- •Prophylactic Unfractionated Heparin (5000 Units BID or TID) within 6 hours
研究组 & 干预措施
ultra-sound guided femoral nerve block
Patients in this arm will receive a bed-side ultrasound guided femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)
干预措施: ultra-sound guide (Other)
ultra-sound guided femoral nerve block
Patients in this arm will receive a bed-side ultrasound guided femoral nerve block with analgesia 0.5% bupivacaine (2mg/kg)
干预措施: bupivacaine (Drug)
standard of care- IV morphine
Patients in this arm will have the femoral nerve block block with no ultrasound for guidance with analgesia (IV morphine)
干预措施: morphine (Drug)
结局指标
主要结局
pain intensity reduction
时间窗: 4 hours after initiation of study proceduure
Evaluation of pain severity and relief will be assessed utilizing a Visual Analog Scale (VAS)
次要结局
未报告次要终点
研究者
Beatrice Hoffmann
Principal Investigator
Beth Israel Deaconess Medical Center