Needle Guidance in Ultrasound Guided Nerve Blocks

Effect of InfinitiPlusTM Needle Guidance in Ultrasound Guided Regional Anesthesia

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 Overview

• Status: Completed
• Conditions: Elective Knee Surgery
• Intervention / Treatment: Device: Infiniti Plus needle guidance system; Device: Conventional block needle

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Alparslan Turan, The Cleveland Clinic

Publications and helpful links

General Publications

• Turan A, Babazade R, Elsharkawy H, Esa WA, Maheshwari K, Farag E, Zimmerman NM, Soliman LM, Sessler DI. Novel needle guide reduces time to perform ultrasound-guided femoral nerve catheter placement: A randomised controlled trial. Eur J Anaesthesiol. 2017 Mar;34(3):135-140. doi: 10.1097/EJA.0000000000000584.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 13-1299