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This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.
Protocols in perioperative pain management during total joint arthroplasty (TJA) have contributed to early discharge after surgery. As practices move to favor ambulatory surgery in total joint arthroplasty changes must be made to postoperative pain and nausea management. Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea and vomiting are known detrimental side effects. The use of systemic steroids has also been shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and increase the distance of ambulation without increasing the rate of surgical site infection or prosthetic joint infection. As more same-day total joint replacement is incorporated into practice, an oral alternative may prove beneficial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm B: Oral Dexamethasone | Experimental | Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days |
|
| Arm A: Placebo | Placebo Comparator | Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 4 mg bid for 4 days |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Postoperative pain will be collected via visual analog scores | 3 weeks following surgery |
| Postoperative Nausea | Postoperative Nausea will be collected via visual analog scores | 3 weeks following surgery |
| Opioid Consumption | Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded | 6 months |
| Antiemetic Consumption | 6 months | |
| Episodes of Nausea | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Incidence of surgical site infection, acute prosthetic joint infection | 6 months |
| Patient-reported outcome scores (PROMS) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Shaw, M.D. | Contact | 414-405-8544 | jshaw5@hfhs.org |
| Name | Affiliation | Role |
|---|---|---|
| Jason Davis, M.D. | Henry Ford Health System | Principal Investigator |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 16, 2024 | Mar 12, 2024 | 1 |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
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| Drug |
oral placebo |
|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | 6 months |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |