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PI leaving institution
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The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | 20 mL liposomal bupivacaine injected once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal bupivacaine | Drug | injected as an axillary block |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radial and Ulnar Arterial Diameter | Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measured by Numerical Rating Scale | Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable) | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Soberon, MD | Ochsner Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel (Bupivacaine Liposome Injectable Suspension) | 20 mL Exparel (bupivacaine liposome injectable suspension) injected once liposomal bupivacaine: injected as an axillary block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel | 20 mL liposomal bupivacaine injected once liposomal bupivacaine: injected as an axillary block |
| 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 |
| 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 | Radial and Ulnar Arterial Diameter | Radial and ulnar artery diameter was measured at baseline and 60 min after with a Doppler ultrasound system. A marker was used to indicate the site of initial transducer placement on the forearm to ensure that subsequent scans were performed at the same location. | Posted | Mean | Full Range | centimeters | 1 hour |
|
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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 | Exparel | 20 mL liposomal bupivacaine injected once liposomal bupivacaine: injected as an axillary block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ken Bode | Ochsner Health System | 504.842.1936 | ken.bode@ochsner.org |
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| ID | Term |
|---|---|
| D017675 | CREST Syndrome |
| D016491 | Peripheral Vascular Diseases |
| D011928 | Raynaud Disease |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Participants |
|
| 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 |
|
| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Secondary | Pain Measured by Numerical Rating Scale | Numerical rating scale pain scores range from 0 (absence of pain) to 10 (worst pain imaginable) | Posted | Mean | Full Range | units on a scale | 1 month |
|
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| 0 |
| 13 |
| 0 |
| 13 |
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| D004066 | Digestive System Diseases |
| D000090122 | Livedoid Vasculopathy |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013684 | Telangiectasis |
| D045745 | Scleroderma, Limited |
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D017445 | Skin Diseases, Vascular |
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |