Oral Steroid in Controlling Pain After TKA

January 24, 2020 updated by: Supakit Kanitnate, Thammasat University

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

To compare efficacy of oral steroid in controlling pain after TKA

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathumthani
      • Khlong Luang, Pathumthani, Thailand, 066
        • Recruiting
        • department of orthopaedic surgery, Faculty of medicine, Thammasat university
        • Principal Investigator:
          • Nattapol Tammachote, M.D.
        • Contact:
        • Sub-Investigator:
          • Supakit Kanitnate, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexamethasone 16 mg
Dexamethasone (4mg) 4 tab oral once daily in the morning
Drug: Dexamethasone Oral
To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA
ACTIVE_COMPARATOR: Dexamethasone 8 mg
Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning
Drug: Dexamethasone Oral
To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA
PLACEBO_COMPARATOR: Placebo
Placebo 4 tab oral once daily in the morning
Drug: Dexamethasone Oral
To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: 12, 24 ,36, 48, 60 and 72 hours after surgery
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
Time Frame: in the first 72 hours after surgery
rate of nausea and vomiting
in the first 72 hours after surgery
Range of motion of the knee
Time Frame: 24, 72 hours then 2, 6, 12 weeks after surgery
Flexion and extension angle
24, 72 hours then 2, 6, 12 weeks after surgery
Functional outcome
Time Frame: 2, 6,12 weeks after surgery
Modified WOMAC score
2, 6,12 weeks after surgery
Blood sugar
Time Frame: At 8.00 am of 1, 2, 3 days after surgery
Fasting blood sugar level
At 8.00 am of 1, 2, 3 days after surgery
inflammatory level
Time Frame: At 8.00 am of 1, 2, 3 days and 2 weeks after surgery
C-reactive protein level
At 8.00 am of 1, 2, 3 days and 2 weeks after surgery
Wound complications
Time Frame: 3 months after surgery
Deep and superficial wound infection, wound dehiscense
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (ACTUAL)

January 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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