Needle Guidance in Ultrasound Guided Nerve Blocks

Study Overview
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Brief Summary
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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.

Official Title
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Effect of InfinitiPlusTM Needle Guidance in Ultrasound Guided Regional Anesthesia

Conditions
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Elective Knee Surgery

Intervention / Treatment
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* Device: Infiniti Plus needle guidance system
* Device: Conventional block needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women 18-85 years old Scheduled for elective knee surgery and expected to receive a femoral nerve block and catheter Written informed consent Exclusion Criteria: Contraindications to femoral block such as coagulopathy, infection at the needle insertion site and allergy to local anesthetics Pregnancy Preexisting neuropathy involving the surgical limb

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infiniti Plus needle guidance system<br>ultrasound guidance with the InfinitiPlus (TM) needle guidance system | Device: Infiniti Plus needle guidance system<br>* The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.<br>|
| Other: conventional block needle<br>ultrasound guidance with a conventional block needle | Device: Conventional block needle<br>* conventional block needle used for insertion of femoral nerve catheters.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System |  | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block Failure | Number of patients who had block failure | 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. | 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. | From start of block procedure until block placement |