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OpenTrials
Completed

NCT Number: NCT02080481

Needle Guidance in Ultrasound Guided Nerve Blocks

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infiniti Plus needle guidance system

Device

The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.

Conventional block needle

Device

conventional block needle used for insertion of femoral nerve catheters.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Block Failure

    Time frame: start of surgery until femoral nerve block completion

    Number of patients who had block failure

  2. > 1 Block Attempt

    Time frame: 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.

  3. Percentage of Time With Perfect Needle Visibility

    Time frame: From start of block procedure until block placement

    Percentage of time that perfect needle visibility was visualized on ultrasound.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Effect of InfinitiPlusTM Needle Guidance in Ultrasound Guided Regional Anesthesia

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 6, 2014
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.