Pain
Conditions
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.
Interventions
DRUGFemoral Nerve Block
Femoral Nerve Block for isolated femur fractures
DEVICEEchogenic 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.
DEVICEStandard of care needle
The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
DEVICEUltrasound
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Pain Level | baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures
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.
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.
The control group will receive ultrasound-guided femoral nerve block using standard of care needles. | 4 |
| Standard of Care Needle The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
Femoral Nerve Block: Femoral Nerve Block for isolated femur fractures
Standard of care needle: The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
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.
The control group will receive ultrasound-guided femoral nerve block using standard of care needles. | 8 |
| Total | 12 |
Baseline characteristics
| Characteristic | Echogenic Needle | Standard of Care Needle | Total |
|---|---|---|---|
| Age, Continuous | 51.25 years STANDARD_DEVIATION 35.55 | 66.88 years STANDARD_DEVIATION 13.7 | 61.67 years STANDARD_DEVIATION 22.87 |
| Region of Enrollment United States | 4 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 8 |
| serious Total, serious adverse events | 0 / 4 | 0 / 8 |
Outcome results
Primary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echogenic Needle | Patient Pain Level | 7.50 units on a scale | Standard Deviation 2.38 |
| Standard of Care Needle | Patient Pain Level | 8.00 units on a scale | Standard Deviation 2.07 |
Primary
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.
Time frame: 60 minutes after initial femoral block
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Echogenic Needle | Patient Pain Level | 1.25 units on a scale | Standard Deviation 2.5 |
| Standard of Care Needle | Patient Pain Level | 3.75 units on a scale | Standard Deviation 2.92 |