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

Peripheral Nerve Blocks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02614222
• Other study ID #: CGM 15-002
• Status: Recruiting
• Phase: N/A
• First received: November 19, 2015
• Last updated: June 10, 2016
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: June 2016
• Source: Clear Guide Medical
• Contact: Ronak Desai, DO
• Phone: 856-342-2000
• Email: desai-ronak[@]cooperhealth.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Peripheral Nerve Blocks

Intervention

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.

Locations

Country	Name	City	State
United States	The Cooper Health System	Camden	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Clear Guide Medical	The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to correctly identify the neural structure(s) and induce the peripheral nerve block		Immediately following intervention	No
Secondary	Clinician rating of the device	Clinician rates the device on a scale of 1-10. This also includes a questionnaire.	Immediately following intervention	No
Secondary	Number of attempts		Immediately following intervention	No
Secondary	Number of times needle needs repositioning		Immediately following intervention	No
Secondary	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, using a questionnaire.	Immediately following intervention	No
Secondary	Amount of rescue opioids needed		Immediately following intervention	Yes
Secondary	Incidence of postoperative nausea and vomiting		Immediately following intervention	Yes
Secondary	Undesired muscle weakness measured subjectively	Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.	Immediately following intervention	Yes