Oral Steroid in Controlling Pain After TKA

Thammasat University

Status and phase: Unknown; Phase 4

Conditions: Pain, Acute

Treatments: Drug: Dexamethasone Oral

Study type: Interventional

Funder types: Other

Identifiers

NCT04244695

OrthoTU11

Details and patient eligibility

About

To compare efficacy of oral steroid in controlling pain after TKA

Full description

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

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups, including a placebo group

Dexamethasone 16 mg

Experimental group

Description:

Dexamethasone (4mg) 4 tab oral once daily in the morning

Treatment:

Drug: Dexamethasone Oral

Dexamethasone 8 mg

Active Comparator group

Description:

Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning

Treatment:

Drug: Dexamethasone Oral

Placebo

Placebo Comparator group

Description:

Placebo 4 tab oral once daily in the morning

Treatment:

Drug: Dexamethasone Oral