Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles

Conditions
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Pain

Intervention / Treatment
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* Drug: Femoral Nerve Block
* Device: Echogenic needle
* Device: Standard of care needle
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echogenic needle<br>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. | Drug: Femoral Nerve Block<br>* Femoral Nerve Block for isolated femur fractures<br>Device: Echogenic needle<br>* 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.<br>Device: Ultrasound<br>* 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. The control group will receive ultrasound-guided femoral nerve block using standard of care needles.<br>|
| Active Comparator: Standard of care needle<br>The control group will receive ultrasound-guided femoral nerve block using standard of care needles. | Drug: Femoral Nerve Block<br>* Femoral Nerve Block for isolated femur fractures<br>Device: Standard of care needle<br>* The control group will receive ultrasound-guided femoral nerve block using standard of care needles.<br>Device: Ultrasound<br>* 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. The control group will receive ultrasound-guided femoral nerve block using standard of care needles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Pain Level | 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. | baseline | 
| Patient Pain Level | 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. | 60 minutes after initial femoral block |