Oral Steroid in Controlling Pain After TKA

Phase 4

• Conditions: Pain, Acute
• Interventions: Drug: Dexamethasone Oral

• Registration Number: NCT04244695
• Lead Sponsor: Thammasat University

Brief Summary

To compare efficacy of oral steroid in controlling pain after TKA

Detailed Description

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

Study Timeline

• Study Start: 2019-09-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-24
• Last Update Submitted: 2020-01-24
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-28
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Dexamethasone Oral	Placebo 4 tab oral once daily in the morning
Dexamethasone 16 mg	Dexamethasone Oral	Dexamethasone (4mg) 4 tab oral once daily in the morning
Dexamethasone 8 mg	Dexamethasone Oral	Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning

Primary Outcome Measures

Name	Time	Method
Pain level	12, 24 ,36, 48, 60 and 72 hours after surgery	VAS for pain (0-100) at rest and on motion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

department of orthopaedic surgery, Faculty of medicine, Thammasat university; 🇹🇭 Khlong Luang, Pathumthani, Thailand