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Protocol not feasible as written
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Patients will be randomized (like the flip of a coin) to receive Exparel and a nerve block, standard of care for this procedure, or Exparel alone for pain management after surgery. They will also be asked to complete questionnaires before surgery, during their stay at the hospital after surgery, then at 3 months, 6 months and 12 months after surgery to assess pain and/or function levels, as well as the amount of pain medicine patients have used after surgery. Patients' leg strength will be measured immediately after surgery and again at 3, 6 and 12 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel plus Adductor Canal Block | Experimental | Adductor canal block with 20 cc 0.5% Ropivacaine with 1:400,000 epinephrine and 100mcg of clonidine |
|
| Exparel plus Placebo Block | Placebo Comparator | Adductor canal block with 20 cc saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain as assessed by Visual Analog Scale (VAS) | Pain, as assessed by Visual Analog Scale (VAS) | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Function as assessed by Knee Society Score (KSS) and EQ-5D | Function, as assessed by Knee Society Score (KSS) and EQ-5D | 12 Months |
| Opioid consumption as assessed by dosage and frequency of narcotic usage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brayton Shirley | Steadman Hawkins Clinic of the Carolinas - Greenville Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steadman Hawkins Clinic of the Carolinas - Greenville Health System | Greenville | South Carolina | 29615 | United States |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004837 | Epinephrine |
| D003000 | Clonidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine |
| Drug |
|
| Epinephrine | Drug |
|
| Clonidine | Drug |
|
| Saline | Drug |
|
Opioid consumption, as assessed by dosage and frequency of narcotic usage
| 30 hours |
| D012216 |
| Rheumatic Diseases |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |