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Unable to continue research due to time constraints
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Anterior cruciate ligament reapair is a painful procedure. Single shot femoral and sciatic nerve block only last 12-16 hrs. Since dexamethasone prolongs brachial plexus block, using it in lower extremity blocks will prolong the analgesia to provide better outpatient pain relief after surgery at home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | in this group, plain bupivacaine will be used to block femoral and sciatic nerve |
|
| Dexamethasone | Experimental | Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethsone | Drug |
| ||
| Bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia Duration | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tariq Malik, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | in this group, plain bupivacaine will be used to block femoral and sciatic nerve Bupivacaine |
| FG001 | Dexamethasone | Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve dexamethsone Bupivacaine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
study terminated prematurely
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | in this group, plain bupivacaine will be used to block femoral and sciatic nerve Bupivacaine |
| BG001 | Dexamethasone | Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve dexamethsone Bupivacaine |
| 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 | Analgesia Duration | study terminated early due to lack of resources to recruit subjects and no data was collected for Outcome measures | Posted | 72 hours |
|
|
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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 | in this group, plain bupivacaine will be used to block femoral and sciatic nerve Bupivacaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TARIQ MALIK | University of Chicago | 773-8342643 | tmalik@dacc.uchicago.edu |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Dexamethasone | Bupivacaine mixed with dexamethasone will be used to block femoral and sciatic nerve dexamethsone Bupivacaine | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000588 |
| Amines |