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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Nerve Blocks
• Intervention / Treatment: Device: Peripheral Nerve Blocks with CAIG

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • The Cooper Health System

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripheral Nerve Block with CAIG; The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.	Device: Peripheral Nerve Blocks with CAIG; 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
No Intervention: Peripheral Nerve Block without CAIG; The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block	Immediately after intervention (within 2 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Rating of the Device	Clinician rates the device on a scale of 1-10. This also includes a questionnaire.	Immediately following intervention (within 2 hours)
Number of Attempts	Number of instrument pricks before target is reached	Immediately following intervention (within 2 hours)
Number of Times Needle Needs Repositioning		Immediately following intervention (within 2 hours)
Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire	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.	Post-op day 1
Number of Patients That Needed Rescue Opioids		During hospital stay (maximum 3 days)
Incidence of Postoperative Nausea and Vomiting	Number of participants that reported postoperative nausea and vomiting	During hospital stay (maximum 3 days)
Undesired Muscle Weakness Measured Subjectively	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.	During hospital stay (maximum 3 days)

Collaborators and Investigators

• Sponsor: Clear Guide Medical
• Collaborators: The Cooper Health System
• Investigators: Principal Investigator: Ronak Desai, DO, The Cooper Health System

Study record dates

Study Major Dates

• Study Start: October 26, 2015
• Primary Completion (Actual): May 25, 2016
• Study Completion (Actual): May 25, 2016

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 7, 2017
• Last Update Submitted That Met QC Criteria: June 12, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Ultrasound; Peripheral Nerve Block; Needle Guidance; Computer Assisted Instrument Guidance (CAIG); Needle path; Clear Guide ONE
• Other Study ID Numbers: CGM 15-002