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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
27
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.
The Cooper Health System
Camden, New Jersey, United States
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
Time frame: Immediately after intervention (within 2 hours)
Clinician Rating of the Device
Clinician rates the device on a scale of 1-10. This also includes a questionnaire.
Time frame: Immediately following intervention (within 2 hours)
Number of Attempts
Number of instrument pricks before target is reached
Time frame: Immediately following intervention (within 2 hours)
Number of Times Needle Needs Repositioning
Time frame: 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.
Time frame: Post-op day 1
Number of Patients That Needed Rescue Opioids
Time frame: During hospital stay (maximum 3 days)
Incidence of Postoperative Nausea and Vomiting
Number of participants that reported postoperative nausea and vomiting
Time frame: 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.
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Time frame: During hospital stay (maximum 3 days)