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NCT04244695 Clinical Trial

Oral Steroid in Controlling Pain After TKA

Pain, Acute Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04244695
Other study ID # OrthoTU11
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 1, 2019
Est. completion date December 2020

Study information
Verified date January 2020
Source Thammasat University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare efficacy of oral steroid in controlling pain after TKA

Description:

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

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone Oral
To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA

Locations
Country Name City State
Thailand department of orthopaedic surgery, Faculty of medicine, Thammasat university Khlong Luang Pathumthani

Sponsors (1)
Lead Sponsor Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain level VAS for pain (0-100) at rest and on motion 12, 24 ,36, 48, 60 and 72 hours after surgery
Secondary nausea and vomiting rate of nausea and vomiting in the first 72 hours after surgery
Secondary Range of motion of the knee Flexion and extension angle 24, 72 hours then 2, 6, 12 weeks after surgery
Secondary Functional outcome Modified WOMAC score 2, 6,12 weeks after surgery
Secondary Blood sugar Fasting blood sugar level At 8.00 am of 1, 2, 3 days after surgery
Secondary inflammatory level C-reactive protein level At 8.00 am of 1, 2, 3 days and 2 weeks after surgery
Secondary Wound complications Deep and superficial wound infection, wound dehiscense 3 months after surgery
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