Oral Steroid in Controlling Pain After TKA

NCT ID: NCT04244695

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-12-31

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

Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone 16 mg

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

Group Type EXPERIMENTAL

Dexamethasone Oral

Intervention Type DRUG

To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA

Dexamethasone 8 mg

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

Group Type ACTIVE_COMPARATOR

Dexamethasone Oral

Intervention Type DRUG

To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA

Placebo

Placebo 4 tab oral once daily in the morning

Group Type PLACEBO_COMPARATOR

Dexamethasone Oral

Intervention Type DRUG

To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA

Interventions

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Dexamethasone Oral

To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA

Intervention Type DRUG

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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Supakit Kanitnate

membership

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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department of orthopaedic surgery, Faculty of medicine, Thammasat university

Khlong Luang, Changwat Pathum Thani, Thailand

Site Status RECRUITING

Countries

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Thailand

Facility Contacts

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supakit kanitnate

Role: primary

6629260000

Other Identifiers

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OrthoTU11

Identifier Type: -

Identifier Source: org_study_id

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