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| Name | Class |
|---|---|
| Creighton University Medical Center | OTHER |
| CHI Health Mercy Hospital | OTHER |
Liposomal bupivacaine is a novel local anesthetic designed for prolonged pain relief. Despite its long-acting analgesic potential, liposomal bupivacaine is significantly more expensive than other local anesthetic alternatives. The primary aim of this investigation is to examine whether or not liposomal bupivacaine provides superior pain relief or clinically significant opioid-sparing effects versus a control to justify its cost.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine | Active Comparator | Periarticular infiltration of 20cc of liposomal bupivacaine with 20cc of normal saline administered prior to cementation of knee implants |
|
| bupivacaine HCl, morphine, epinephrine, methylprednisolone | Active Comparator | Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone administered prior to cementation of knee implants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean visual analog scale (VAS) pain scores | Self-reported pain scores from 0=no pain to 10=severe pain | Night of surgery |
| Mean visual analog scale (VAS) pain scores | Self-reported pain scores from 0=no pain to 10=severe pain | Post-operative day 1 |
| Mean visual analog scale (VAS) pain scores | Self-reported pain scores from 0=no pain to 10=severe pain | Post-operative day 2 |
| Pain assessment phone call | Subjects will be called on post-operative day three by one of the investigators of the study. Subjects will be asked to rate their current pain level from 1 to 10 and to rate their worst pain level from 1 to 10 that day. | Post-operative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Number of patients with complications | Complications will be followed for the duration of patients' hospital stay, an expected average of 2-3 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clifford K Boese, MD | Miller Orthopedic Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miller Orthopedic Specialists | Council Bluffs | Iowa | 51503 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D009020 | Morphine |
| D004837 | Epinephrine |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| bupivacaine HCl, morphine, epinephrine, methylprednisolone | Drug | Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| 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 |
| 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 |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |