Needle Guidance in Ultrasound Guided Nerve Blocks

Not Applicable

Completed

Conditions: Elective Knee Surgery

Interventions: Device: Infiniti Plus needle guidance system
Device: Conventional block needle

Registration Number: NCT02080481

Lead Sponsor: The Cleveland Clinic

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 135

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infiniti Plus needle guidance system	Infiniti Plus needle guidance system	ultrasound guidance with the InfinitiPlus (TM) needle guidance system
conventional block needle	Conventional block needle	ultrasound guidance with a conventional block needle

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Block Failure	start of surgery until femoral nerve block completion	Number of patients who had block failure
> 1 Block Attempt	from start of block procedure until block placement	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.
Percentage of Time With Perfect Needle Visibility	From start of block procedure until block placement	Percentage of time that perfect needle visibility was visualized on ultrasound.