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

NCT02614222 | Completed Results

• 1 other identifier: CGM 15-002
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Nerve Blocks

Keywords

Computer Assisted Instrument Guidance (CAIG); Peripheral Nerve Block; Clear Guide ONE; Needle path; Needle Guidance; Ultrasound

Outcome Measures

Primary Outcomes (1)

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

  Immediately after intervention (within 2 hours)

Secondary Outcomes (7)

• Clinician Rating of the Device

  Immediately following intervention (within 2 hours)

• Number of Attempts

  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

  Post-op day 1

• Number of Patients That Needed Rescue Opioids

  During hospital stay (maximum 3 days)

Study Arms (2)

Peripheral Nerve Block with CAIG

EXPERIMENTAL

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

Peripheral Nerve Block without CAIG

NO INTERVENTION

The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.

Interventions

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.

Also known as: Clear Guide ONE

Peripheral Nerve Block with CAIG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clear Guide Medical: lead
• The Cooper Health System: collaborator

Study Sites (1)

The Cooper Health System

Camden, New Jersey, 08103, United States

Location

Results Point of Contact

• Title: Dr. Ronak Desai
• Organization: The Cooper Health System

desai-ronak@cooperhealth.edu

856-342-2000

Study Officials

• Ronak Desai, DO

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 25, 2015
• Study Start: October 26, 2015
• Primary Completion: May 25, 2016
• Study Completion: May 25, 2016
• Last Updated: July 7, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-06

Locations

US (1)