Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks
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|ClinicalTrials.gov Identifier: NCT02614222|
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : June 14, 2017
Last Update Posted : July 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Nerve Blocks||Device: Peripheral Nerve Blocks with CAIG||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks|
|Study Start Date :||October 26, 2015|
|Actual Primary Completion Date :||May 25, 2016|
|Actual Study Completion Date :||May 25, 2016|
Experimental: Peripheral Nerve Block with CAIG
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
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.
Other Name: Clear Guide ONE
No Intervention: Peripheral Nerve Block without CAIG
The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
- 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 [ Time Frame: Immediately following intervention (within 2 hours) ]Clinician rates the device on a scale of 1-10. This also includes a questionnaire.
- Number of Attempts [ Time Frame: Immediately following intervention (within 2 hours) ]Number of instrument pricks before target is reached
- Number of Times Needle Needs Repositioning [ Time Frame: Immediately following intervention (within 2 hours) ]
- Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire [ Time Frame: 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.
- Number of Patients That Needed Rescue Opioids [ Time Frame: During hospital stay (maximum 3 days) ]
- Incidence of Postoperative Nausea and Vomiting [ Time Frame: During hospital stay (maximum 3 days) ]Number of participants that reported postoperative nausea and vomiting
- Undesired Muscle Weakness Measured Subjectively [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614222
|United States, New Jersey|
|The Cooper Health System|
|Camden, New Jersey, United States, 08103|
|Principal Investigator:||Ronak Desai, DO||The Cooper Health System|