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This two tiered study is a multi-center, open label, surveillance study of the use of continuous nerve blocks with the ON-Q® C-bloc and either nerve stimulator or ultrasound guided continuous nerve block techniques. This study was developed to investigate specific aspects of complication rates related to continuous nerve block techniques in patients undergoing orthopedic surgical procedures.
Continuous peripheral nerve block techniques require the placement of catheters near target peripheral nerves. The placement of these catheters is guided by either ultrasound visualization, nerve stimulation or a combination of the two.
This surveillance study was designed to look at the rates of catheter placement related complications with the two techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USPNB | Active Comparator | Ultrasound imaging guided peripheral nerve block |
|
| NSPNB | Active Comparator | Peripheral nerve stimulator guided peripheral nerve block catheter placement for continuous infusion of local anesthetic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound imaging | Device | Ultrasound guided techniques for placement of peripheral nerve block catheters for continuous infusion of local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complications of Peripheral Nerve Block | Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic | Preoperative through 3 days post operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Rodrigo, MD | Roper Hospital, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Joint and Spine | Chandler | Arizona | 85224 | United States | ||
| Santa Clara Valley Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | USPNB | ultrasound imaging guided peripheral nerve block |
| FG001 | NSPNB | Stimulator guided nerve block |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Peripheral nerve stimulator | Device | either stimulating needle or stimulating catheter used for placement of catheter for continuous infusion of local anesthetic |
|
| San Jose |
| California |
| 4088855230 |
| United States |
| Avista Adventist Hospital | Louisville | Colorado | 80027 | United States |
| Kennestone Hospital | Atlanta | Georgia | 30060 | United States |
| The Medical Center of Bowling Green | Bowling Green | Kentucky | 42101 | United States |
| Caritas Good Samaritan | Stoughton | Massachusetts | 02072 | United States |
| Wesley Medical Center | Hattiesburg | Mississippi | 39402 | United States |
| DesPeres Hospital | St Louis | Missouri | 63131 | United States |
| St. Vincents Catholic Medical Center | New York | New York | 10011 | United States |
| Charlotte Medical Center | Charlotte | North Carolina | 28203 | United States |
| Miami Valley Hospital | Dayton | Ohio | 45459 | United States |
| Bailey Medical Center | Owasso | Oklahoma | 74055 | United States |
| Roper Hospital | Charleston | South Carolina | 29403 | United States |
| Memorial Herman Hospital | Houston | Texas | 77030 | United States |
| Titus Regional Medical Center | Mount Pleasant | Texas | 75455 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 25298 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | USPNB | ultrasound imaging guided peripheral nerve block |
| BG001 | NSPNB | Stimulator guided nerve block |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Complications of Peripheral Nerve Block | Adverse events related to performance of peripheral nerve catheter placement for continuous infusion of local anesthetic | Intent to treat (ITT) | Posted | Number | participants | Preoperative through 3 days post operative |
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|
7 days postoperative
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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 | USPNB | ultrasound imaging guided peripheral nerve block | 0 | 1,324 | 7 | 1,324 | ||
| EG001 | NSPNB | Stimulator guided nerve block | 0 | 497 | 14 | 497 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VASCULAR PUNCTURE | Vascular disorders | Systematic Assessment |
| ||
| Infection | Infections and infestations | Systematic Assessment | CATHETER SITE LOCAL INFECTION/INFLAMMATION |
| |
| motor block | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Dine Director of Clinical Research | I-Flow Corporation | 513-253-8033 | alan.dine@kcc.com |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| >=65 years |
|
| Male |
|