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The purpose of this study is to evaluate the efficacy of an intravenous (IV) perioperative dexamethasone regime in the clinical outcomes after a robotic-assisted Total Knee Arthroplasty (TKA) in a Hispanic population. The study aims to propose an alternative to opioid-based pain treatment following TKA. The study hopefully validates the use of a two-dose, 8mg intravenous dexamethasone regimen for improving pain and range of motion scores in patients undergoing primary, unilateral TKA for osteoarthritis. One dose will be applied prior to incision and the other at post-operative day (POD) 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving intravenous dexamethasone | Experimental |
| |
| Patients receiving intravenous morphine and oral oxycodone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Two 8 mg doses. One dose applied prior to incision and the other at POD1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| POD 1 Visual Analogue Scale Pain Scores | Range: 0-10 (10 indicates highest degree of pain) | Measured at 7:00AM day after surgery |
| POD 2 Visual Analogue Scale Pain Scores | Range: 0-10 (10 indicates highest degree of pain) | Measured at 7:00AM two days after surgery |
| POD 3 Visual Analogue Scale Pain Scores | Range: 0-10 (10 indicates highest degree of pain) | Measured at 7:00AM three days after surgery |
| POD 1 Range of Motion | Measured at 7:00AM the day after surgery | |
| POD 2 Range of Motion | Measured at 7:00AM two days after surgery | |
| POD 3 Range of Motion | Measured at 7:00AM three days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Dextrose Concentration (mg/dL) | Measured at 7:00AM for 3 days after surgery | |
| Length of Stay | Measured in days | From hospital admission to the date of discharge (About 3 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra M Claudio Marcano, MD | Contact | 787-221-5210 | alexandra.claudio1@upr.edu | |
| Norberto J Torres, MD | Contact | 787-403-8109 | norberto.torres1@upr.edu |
| Name | Affiliation | Role |
|---|---|---|
| Antonio M López Otero, MD | Orthopaedic Surgery Section, University of Puerto Rico Medical Sciences Campus San Juan, Puerto Rico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Puerto Ric-Dr. Federico Trilla Hospital | Carolina | 00984 | Puerto Rico |
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| Morphine | Drug | Morphine 0.1 mg per kg intravenous every 6 hours |
|
| Oxycodone and acetaminophen | Drug | 2 tabs of oral oxycodone combined with acetaminophen every 6 hours (the same pill includes both drugs) |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D009020 | Morphine |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 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 |
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