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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiniti Plus needle guidance system | Experimental | ultrasound guidance with the InfinitiPlus (TM) needle guidance system |
|
| conventional block needle | Other | ultrasound guidance with a conventional block needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infiniti Plus needle guidance system | Device | The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System | time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Block Failure | Number of patients who had block failure | start of surgery until femoral nerve block completion |
| > 1 Block Attempt | Number of block attempts was collected for each patient as > 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alparslan Turan | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28009637 | Derived | Turan A, Babazade R, Elsharkawy H, Esa WA, Maheshwari K, Farag E, Zimmerman NM, Soliman LM, Sessler DI. Novel needle guide reduces time to perform ultrasound-guided femoral nerve catheter placement: A randomised controlled trial. Eur J Anaesthesiol. 2017 Mar;34(3):135-140. doi: 10.1097/EJA.0000000000000584. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Infiniti Plus Needle Guidance System | ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks. |
| FG001 | Conventional Block Needle | ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Infiniti Plus Needle Guidance System | ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks. |
| BG001 | Conventional Block Needle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System | Posted | Median | Inter-Quartile Range | seconds | time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Infiniti Plus Needle Guidance System | ultrasound guidance with the InfinitiPlus (TM) needle guidance system Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aplarslan Turan, MD | Cleveland Clinic | 216-445-9857 | turana@ccf.org |
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| Conventional block needle | Device | conventional block needle used for insertion of femoral nerve catheters. |
|
| from start of block procedure until block placement |
| Percentage of Time With Perfect Needle Visibility | Percentage of time that perfect needle visibility was visualized on ultrasound. | From start of block procedure until block placement |
ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Intraoperative management strategy | Count of Participants | Participants |
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| Secondary | Block Failure | Number of patients who had block failure | Posted | Count of Participants | Participants | start of surgery until femoral nerve block completion |
|
|
|
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| Secondary | > 1 Block Attempt | Number of block attempts was collected for each patient as > 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it. | Posted | Count of Participants | Participants | from start of block procedure until block placement |
|
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| Secondary | Percentage of Time With Perfect Needle Visibility | Percentage of time that perfect needle visibility was visualized on ultrasound. | Posted | Mean | Standard Deviation | percentage of time | From start of block procedure until block placement |
|
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| EG001 | Conventional Block Needle | ultrasound guidance with a conventional block needle Conventional block needle: conventional block needle used for insertion of femoral nerve catheters. | 0 | 67 | 0 | 67 |
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