Clinical trial NCT02046317: Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
Official title: Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Pain Level
timeFrame: baseline
measure: Patient Pain Level
timeFrame: 60 minutes after initial femoral block
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital Texas Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Carlos J Roldan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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