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

Phase 4

Terminated

Interventions: Drug: Femoral Nerve Block
Device: Standard of care needle
Device: Echogenic needle
Device: Ultrasound

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard of care needle	Standard of care needle	The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Echogenic needle	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.
Echogenic needle	Ultrasound	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.
Echogenic needle	Femoral Nerve Block	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.
Standard of care needle	Femoral Nerve Block	The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Standard of care needle	Ultrasound	The control group will receive ultrasound-guided femoral nerve block using standard of care needles.

Primary Outcome Measures

Name	Time	Method
Patient Pain Level	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.

Secondary Outcome Measures

Name	Time	Method

Locations (2): Lyndon Baines Johnson General Hospital
🇺🇸
Houston, Texas, United States
Memorial Hermann Hospital Texas Medical Center
🇺🇸
Houston, Texas, United States