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| Name | Class |
|---|---|
| CIVCO Medical Solutions | UNKNOWN |
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This is an openly randomized controlled parallel group study evaluating the effectiveness of using a guided approach and free-hand approach in performing upper extremity regional blocks. Potential subjects for this study are the patients who are scheduled for upper extremity surgeries requiring supraclavicular and interscalene brachial plexus blocks at Montefiore Medical Center.
Rotating residents who are participating in the study will be randomly assigned either to perform block under guided approach (with the help of needle guidance) or free-hand without the needle guidance. All the blocks will be single injection blocks utilizing the in-plane technique for needle insertion which is the usual protocol in our institution. Each resident will be performing one interscalene block with the device and one without the device and one supraclavicular block with device and one without the device. An independent observer will be present during the case and will be responsible for recording the time taken to perform the block, number of times the needle has been redirected and the number of times the needle is reinserted. This observer will also administer the satisfaction questionnaire. Number of time needle is redirected and number of times reinserted is also a self reported assessment by the physician who is performing the block. Efficacy of the block will be assessed by the standard of care practiced at our center.
Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Civco needle guidance device will be used while the nerve block is performed. |
|
| Standard of Care | No Intervention | Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Civco Needle Guidance Device | Device | Needle guidance device will be used while nerve block is performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Needle Time; | needle insertion to needle withdrawal | Needle insertion to needle withdrawal, up to 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve Block Procedure Time | How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal. | time from ultrasound contact with skin to needle withdrawal, up to 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amaresh Vydyanathan, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Civco needle guidance device will be used while the nerve block is performed. Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed. |
| FG001 | Standard of Care | Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Civco needle guidance device will be used while the nerve block is performed. Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed. |
| BG001 | Standard of Care |
| 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 | Needle Time; | needle insertion to needle withdrawal | Posted | Median | Inter-Quartile Range | seconds | Needle insertion to needle withdrawal, up to 20 minutes |
|
There were no adverse events reported throughout the duration of our study.
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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 | Intervention | Civco needle guidance device will be used while the nerve block is performed. Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed. |
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A limitation of this study was that most of the clinicians using the device were either senior residents (CA-3's), or fellows. It is possible that this device could provide more or less benefit in newer trainees.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amaresh Vydynathan | Montefiore Medical Center | 718-920-4316 | avydynathan@montefiore.org |
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Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Nerve Block Procedure Time | How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal. | Posted | Median | Inter-Quartile Range | seconds | time from ultrasound contact with skin to needle withdrawal, up to 20 minutes |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Standard of Care | Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone. | 0 | 34 | 0 | 34 | 0 | 34 |
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