Back to resultsOral Steroid in Controlling Pain After TKA
Primary Purpose
Pain, Acute
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Dexamethasone Oral
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring oral corticosteroid, postoperative pain, dexamethasone, total knee arthroplasty
Eligibility Criteria
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
Sites / Locations
- department of orthopaedic surgery, Faculty of medicine, Thammasat universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Dexamethasone 16 mg
Dexamethasone 8 mg
Placebo
Arm Description
Dexamethasone (4mg) 4 tab oral once daily in the morning
Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning
Placebo 4 tab oral once daily in the morning
Outcomes
Primary Outcome Measures
Pain level
VAS for pain (0-100) at rest and on motion
Secondary Outcome Measures
nausea and vomiting
rate of nausea and vomiting
Range of motion of the knee
Flexion and extension angle
Functional outcome
Modified WOMAC score
Blood sugar
Fasting blood sugar level
inflammatory level
C-reactive protein level
Wound complications
Deep and superficial wound infection, wound dehiscense
Full Information
NCT ID
NCT04244695
First Posted
January 24, 2020
Last Updated
January 24, 2020
Sponsor
Thammasat University
1. Study Identification
Unique Protocol Identification Number
NCT04244695
Brief Title
Oral Steroid in Controlling Pain After TKA
Official Title
Efficacy of Oral Corticosteroid in Controlling Pain After Total Knee Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
oral corticosteroid, postoperative pain, dexamethasone, total knee arthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone 16 mg
Arm Type
Experimental
Arm Description
Dexamethasone (4mg) 4 tab oral once daily in the morning
Arm Title
Dexamethasone 8 mg
Arm Type
Active Comparator
Arm Description
Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 4 tab oral once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Oral
Intervention Description
To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA
Primary Outcome Measure Information:
Title
Pain level
Description
VAS for pain (0-100) at rest and on motion
Time Frame
12, 24 ,36, 48, 60 and 72 hours after surgery
Secondary Outcome Measure Information:
Title
nausea and vomiting
Description
rate of nausea and vomiting
Time Frame
in the first 72 hours after surgery
Title
Range of motion of the knee
Description
Flexion and extension angle
Time Frame
24, 72 hours then 2, 6, 12 weeks after surgery
Title
Functional outcome
Description
Modified WOMAC score
Time Frame
2, 6,12 weeks after surgery
Title
Blood sugar
Description
Fasting blood sugar level
Time Frame
At 8.00 am of 1, 2, 3 days after surgery
Title
inflammatory level
Description
C-reactive protein level
Time Frame
At 8.00 am of 1, 2, 3 days and 2 weeks after surgery
Title
Wound complications
Description
Deep and superficial wound infection, wound dehiscense
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
department of orthopaedic surgery, Faculty of medicine, Thammasat university
City
Khlong Luang
State/Province
Pathumthani
ZIP/Postal Code
066
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
supakit kanitnate
Phone
6629260000
Email
naypeng@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nattapol Tammachote, M.D.
First Name & Middle Initial & Last Name & Degree
Supakit Kanitnate, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Oral Steroid in Controlling Pain After TKA
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