An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been recently developed to guide clinicians in performing ultrasound guided nerve blocks. This system helps the clinician to align the needle with ultrasound beam while performing an ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing efficient needle movement while having improved needle shaft and tip visualization. This is a disposable system specifically designed for improving success rate of ultrasound guided block and patient safety. This study will be done with patients having elective knee surgery and a femoral nerve block with a catheter. The nerve block procedure will be performed under ultrasound guidance to help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently developed to try to improve needle guidance in the ultrasound guided nerve block procedure. This study will determine whether femoral nerve block procedures performed under ultrasound guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound guidance and a conventional block needle. The study will also determine whether the InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure, reduces the cost of the procedure, increases the procedure success rate, and improves ultrasound visibility of the needle. Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus (TM) needle guidance system or ultrasound guidance with a conventional block needle. After surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain treatment satisfaction and a questionnaire about recovery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.
conventional block needle used for insertion of femoral nerve catheters.
Cleveland Clinic
Cleveland, Ohio, United States
Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System
Time frame: time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery.
Block Failure
Number of patients who had block failure
Time frame: start of surgery until femoral nerve block completion
> 1 Block Attempt
Number of block attempts was collected for each patient as \> 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it.
Time frame: from start of block procedure until block placement
Percentage of Time With Perfect Needle Visibility
Percentage of time that perfect needle visibility was visualized on ultrasound.
Time frame: From start of block procedure until block placement
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