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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/ANESTHESIO | Other Identifier | UW, Madison | |
| A530900 | Other Identifier | UW, Madison |
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The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
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The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | will get only local anesthetic and epinephrine in block. no additive in block | |
| buprenorphine | Experimental | will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | added to nerve block, 0.3mg one time peripheral block use |
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| Measure | Description | Time Frame |
|---|---|---|
| Time Until First Pain Medication Post-operatively | Time in minutes until first pain medication was take by participant post-operatively | 48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score on Post Operative Day 1 | pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be) | 1 day postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie Donnelly, MD | University of Wisconsin School of Medicine and Public Health, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | will get only local anesthetic and epinephrine in block. no additive in block |
| FG001 | Buprenorphine | will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block Buprenorphine: added to nerve block, 0.3mg one time peripheral block use |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | will get only local anesthetic and epinephrine in block. no additive in block |
| BG001 | Buprenorphine | will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block Buprenorphine: added to nerve block, 0.3mg one time peripheral block use |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Until First Pain Medication Post-operatively | Time in minutes until first pain medication was take by participant post-operatively | The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment.The Overall Number of Participants Analyzed represents the Number of Participants with evaluable data. | Posted | Mean | Standard Deviation | Time in minutes | 48 hrs |
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| Secondary | Pain Score on Post Operative Day 1 | pain score on post operative day 1 was measured on a scale 1-10. higher scores correlates with more severe pain. score range is from '0' (no pain) to 10 (pain as severe as it can be) | The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment | Posted | Median | Inter-Quartile Range | score on a scale | 1 day postoperative |
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Adverse events were not monitored. The study was closed prematurely due to low enrollment and anticipation of future barriers in enrollment
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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 | Control Group | will get only local anesthetic and epinephrine in block. no additive in block | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Buprenorphine | will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block Buprenorphine: added to nerve block, 0.3mg one time peripheral block use | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melanie Donnelly | University of Wisconsin-Madison | 720-848-0000 | melanie.donnelly@ucdenver.edu |
| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| 40-49 |
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| 50-59 |
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| 60-69 |
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| 70-79 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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