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NCT02080481 · ClinicalTrials.gov registry record · NA
Needle Guidance in Ultrasound Guided Nerve Blocks
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 135
- Enrollment target
NCT02080481 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 135 participants.
The verdict
NCT02080481, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
Study Summary
An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been recently developed to guide clinicians in performing ultrasound guided nerve blocks. This system helps the clinician to align the needle with ultrasound beam while performing an ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing efficient needle movement while having improved needle shaft and tip visualization. This is a disposable system specifically designed for improving success rate of ultrasound guided block and patient safety. This study will be done with patients having elective knee surgery and a femoral nerve block with a catheter. The nerve block procedure will be performed under ultrasound guidance to help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently developed to try to improve needle guidance in the ultrasound guided nerve block procedure. This study will determine whether femoral nerve block procedures performed under ultrasound guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound guidance and a conventional block needle. The study will also determine whether the InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure, reduces the cost of the procedure, increases the procedure success rate, and improves ultrasound visibility of the needle. Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus (TM) needle guidance system or ultrasound guidance with a conventional block needle. After surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain treatment satisfaction and a questionnaire about recovery.
Interventions
- DEVICE Infiniti Plus needle guidance system
- DEVICE Conventional block needle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02080481
The ClinicalTrials.gov registry entry for NCT02080481 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 135 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Infiniti Plus needle guidance system is the first listed.
NCT02080481 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02080481 about?
NCT02080481 is a clinical study titled "Needle Guidance in Ultrasound Guided Nerve Blocks". An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been recently developed to guide clinicians in performing ultrasound guided nerve blocks. This system helps the clinician to align the needle with ultrasound beam while performing an ultrasound guided nerve block. Infin...
What is the current status of trial NCT02080481?
This trial is currently completed. It is a NA study. The enrollment target is 135 participants. The study started on 2014-03. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02080481?
The interventions under investigation include: Infiniti Plus needle guidance system (DEVICE), Conventional block needle (DEVICE).
Who is sponsoring clinical trial NCT02080481?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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