Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty

Study Overview
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Brief Summary
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This study aims to determine if oral dexamethasone provides clinically significant improvement in postoperative outcomes, specifically nausea and pain scores.

Detailed Description
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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.

Official Title
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Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty

Conditions
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Arthritis Knee, Postoperative Nausea, Postoperative Pain

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients age 18 and older who will be undergoing joint replacement Exclusion Criteria: Patients with uncontrolled diabetes ( HbA1C, >7.5%), impaired hepatic function (Child class, >B), impaired renal failure (Glomerular filtration rate <60 mL/min/1.73 m2), chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse reaction to corticosteroids, and patients unable to give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm B: Oral Dexamethasone<br>Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days | Drug: Dexamethasone<br>* 4 mg bid for 4 days<br>|
| Placebo Comparator: Arm A: Placebo<br>Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days | Drug: Placebo<br>* oral placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Incidence of surgical site infection, acute prosthetic joint infection | 6 months | 
| Patient-reported outcome scores (PROMS) |  | 6 months | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) |  | 6 months |