Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Nerve Blocks
- Sponsor
- Clear Guide Medical
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
Time Frame: Immediately after intervention (within 2 hours)
Secondary Outcomes
- Clinician Rating of the Device(Immediately following intervention (within 2 hours))
- 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))
- Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire(Post-op day 1)
- Incidence of Postoperative Nausea and Vomiting(During hospital stay (maximum 3 days))
- Undesired Muscle Weakness Measured Subjectively(During hospital stay (maximum 3 days))