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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Nerve Blocks

Intervention / Treatment
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* Device: Peripheral Nerve Blocks with CAIG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral Nerve Block with CAIG<br>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<br>* 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.<br>* Other names: Clear Guide ONE;|
| No Intervention: Peripheral Nerve Block without CAIG<br>The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer Assisted Instrument Guidance (CAIG), Peripheral Nerve Block, Clear Guide ONE, Needle path, Needle Guidance, Ultrasound