Trial Outcomes & Findings for Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles (NCT NCT02046317)
NCT ID: NCT02046317
Last Updated: 2018-12-07
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
baseline
Results posted on
2018-12-07
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
8
|
|
Overall Study
COMPLETED
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Ultrasound Guided Femoral Nerve Block on Isolated Femur Fracture Using Echo Friendly Needles
Baseline characteristics by cohort
| Measure |
Echogenic Needle
n=4 Participants
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.
|
Standard of Care Needle
n=8 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.25 years
STANDARD_DEVIATION 35.55 • n=5 Participants
|
66.88 years
STANDARD_DEVIATION 13.70 • n=7 Participants
|
61.67 years
STANDARD_DEVIATION 22.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselinePain 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.
Outcome measures
| Measure |
Echogenic Needle
n=4 Participants
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.
|
Standard of Care Needle
n=8 Participants
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.
|
|---|---|---|
|
Patient Pain Level
|
7.50 units on a scale
Standard Deviation 2.38
|
8.00 units on a scale
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 60 minutes after initial femoral blockPain 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.
Outcome measures
| Measure |
Echogenic Needle
n=4 Participants
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.
|
Standard of Care Needle
n=8 Participants
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.
|
|---|---|---|
|
Patient Pain Level
|
1.25 units on a scale
Standard Deviation 2.50
|
3.75 units on a scale
Standard Deviation 2.92
|
Adverse Events
Echogenic Needle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care Needle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carlos J Roldan, MD
The University of Texas Health Science Center at Houston
Phone: 713-745-7246
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place