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

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02046317

HSC-MS-11-0035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

12 participants in 2 patient groups

Echogenic needle

Experimental group

Description:

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.

Treatment:

Drug: Femoral Nerve Block

Device: Ultrasound

Device: Echogenic needle

Standard of care needle

Active Comparator group

Description:

The control group will receive ultrasound-guided femoral nerve block using standard of care needles.

Treatment:

Drug: Femoral Nerve Block

Device: Standard of care needle

Device: Ultrasound