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OpenTrials
Completed

NCT Number: NCT02614222

Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks

The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.

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Key information

Conditions

Peripheral Nerve Blocks

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Cooper Health System

Camden, New Jersey, 08103, United States

About this study

This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain
  • Able to give written informed consent

Exclusion criteria

  • Unable to give informed consent
  • Patients in whom regional anesthesia is contradicted

Treatment and study plan

Peripheral Nerve Blocks with CAIG

Device

The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure.

Other names: Clear Guide ONE

Primary outcomes

  1. Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block

    Time frame: Immediately after intervention (within 2 hours)

Secondary outcomes

  1. Clinician Rating of the Device

    Time frame: Immediately following intervention (within 2 hours)

    Clinician rates the device on a scale of 1-10. This also includes a questionnaire.

  2. Number of Attempts

    Time frame: Immediately following intervention (within 2 hours)

    Number of instrument pricks before target is reached

  3. Number of Times Needle Needs Repositioning

    Time frame: Immediately following intervention (within 2 hours)

  4. Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire

    Time frame: Post-op day 1

    Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.

  5. Number of Patients That Needed Rescue Opioids

    Time frame: During hospital stay (maximum 3 days)

  6. Incidence of Postoperative Nausea and Vomiting

    Time frame: During hospital stay (maximum 3 days)

    Number of participants that reported postoperative nausea and vomiting

  7. Undesired Muscle Weakness Measured Subjectively

    Time frame: During hospital stay (maximum 3 days)

    Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.

Sponsors and collaborators

Lead sponsor

Clear Guide Medical

Industry

Collaborators

  • The Cooper Health System

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2015
Registry last updated
Jul 7, 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.

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