N/A
N=27
Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks
Peripheral Nerve Blocks
Bottom Line
View on ClinicalTrials.gov: NCT02614222 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block — 2.606944444; 2.179761905 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Peripheral Nerve Blocks with CAIG (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clear Guide Medical
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block |
2.606944444; 2.179761905 | — |
| SECONDARY Clinician Rating of the Device |
— | — |
| SECONDARY Number of Attempts |
1; 1 | — |
| SECONDARY Number of Times Needle Needs Repositioning |
— | — |
| SECONDARY Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire |
8.727272727; 9.181818182 | — |
| SECONDARY Number of Patients That Needed Rescue Opioids |
6; 5 | — |
| SECONDARY Incidence of Postoperative Nausea and Vomiting |
0; 2 | — |
| SECONDARY Undesired Muscle Weakness Measured Subjectively |
2; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02614222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.