Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Patient Pain Level
研究概览
简要总结
This study aims to determine if there is any difference in the success rate of ultra-sound guided femoral nerve block performed with an echogenic needle versus a standard needle.
详细描述
To date, the published information regarding ultrasound guided femoral nerve blocks (FNB) using echo friendly needle is very limited. More so, there is even less information regarding ultrasound guided nerve blocks using echogenic versus standard of care needles.
This study hopes to add to the general knowledge of pain management in the emergency department (ED) setting and provide a unique perspective on ultrasound-guided techniques using echogenic needles to enhance accuracy and success rate of nerve blocks in ED patients.
The study design will have two comparative arms; in both arms we use the same local anesthetic which is Bupivacaine 0.25% with epinephrine; in all cases a total of 15 mL will be injected around the femoral nerve. Once identified with ultrasound, 5 ml will be injected at lateral, medial, and posterior aspect of the nerve. The experimental arm will receive an FNB using an echogenic needle; and the control group will receive an FNB using standard of care needles.
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
- Double (Participant, Investigator)
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 who present to the emergency department (ED) with isolated femur fracture (no other injuries)
- •Patients who are cognitively alert and are able to verbalize their pain using a visual analog scale (VAS)
- •Patients who are mentally competent to consent for the study
- •Patients who can communicate in English or Spanish
排除标准
- •Gestation
- •Prisoners
- •Patients who cannot communicate in English or in Spanish
- •Patients who have other significant injuries besides a femur fracture
- •Patients who are cognitively impaired and/or unable to verbalize their pain using a visual analog scale (VAS)
- •Patients with allergies to local anesthetics
- •Patients with severe liver disease
- •Patients with existing peripheral neuropathies in the affected limb
- •Patients with history of complications from previous femoral blocks
- •Patients with contraindications for needle insertion at inguinal area
- •Local signs of infection
- •Patient on anticoagulants and/or with history of coagulation disorders
研究组 & 干预措施
Echogenic needle
The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
干预措施: Femoral Nerve Block (Drug)
Echogenic needle
The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
干预措施: Echogenic needle (Device)
Echogenic needle
The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
干预措施: Ultrasound (Device)
Standard of care needle
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
干预措施: Femoral Nerve Block (Drug)
Standard of care needle
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
干预措施: Standard of care needle (Device)
Standard of care needle
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
干预措施: Ultrasound (Device)
结局指标
主要结局
Patient Pain Level
时间窗: 60 minutes after initial femoral block
Pain level will be measured on a numeric visual analogue scale of 0-10 with 0 being no pain and 10 being the worst pain ever.
次要结局
未报告次要终点
研究者
Carlos Roldan
Associate Professor - Emergency Medicine
The University of Texas Health Science Center, Houston