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

Not Applicable

Completed

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.

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Peripheral Nerve Block with CAIG	Peripheral Nerve Blocks with CAIG	The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.

Primary Outcome Measures

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

Secondary Outcome Measures

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