Oral Steroid in Controlling Pain After TKA

Study Overview
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Brief Summary
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To compare efficacy of oral steroid in controlling pain after TKA

Detailed Description
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To compare pain and functional outcome for oral dexamethasone 16 mg, 8 mg and pacebo in patient undergoing unilateral primary total knee arthroplasy

Official Title
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Efficacy of Oral Corticosteroid in Controlling Pain After Total Knee Arthroplasty: A Randomized Controlled Trial

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: Dexamethasone Oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with osteoarthritis of the knee who undergoing unilateral TKA ASA class I-III Informed consent Good cognitive function Exclusion Criteria: Uncontrolled DM (HbA1C > 7) Uncontrolled HT Morbid obesity (BMI > 40) History of bleeding in GI tract Corticosteroid used within 6 months Sever liver or renal impairments Studied drug allergy

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexamethasone 16 mg<br>Dexamethasone (4mg) 4 tab oral once daily in the morning | Drug: Dexamethasone Oral<br>* To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA<br>|
| Active Comparator: Dexamethasone 8 mg<br>Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning | Drug: Dexamethasone Oral<br>* To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA<br>|
| Placebo Comparator: Placebo<br>Placebo 4 tab oral once daily in the morning | Drug: Dexamethasone Oral<br>* To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | VAS for pain (0-100) at rest and on motion | 12, 24 ,36, 48, 60 and 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea and vomiting | rate of nausea and vomiting | in the first 72 hours after surgery | 
| Range of motion of the knee | Flexion and extension angle | 24, 72 hours then 2, 6, 12 weeks after surgery | 
| Functional outcome | Modified WOMAC score | 2, 6,12 weeks after surgery | 
| Blood sugar | Fasting blood sugar level | At 8.00 am of 1, 2, 3 days after surgery | 
| inflammatory level | C-reactive protein level | At 8.00 am of 1, 2, 3 days and 2 weeks after surgery | 
| Wound complications | Deep and superficial wound infection, wound dehiscense | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral corticosteroid, postoperative pain, dexamethasone, total knee arthroplasty