Pain, AcutePhase 4NCT04244695
Oral Steroid in Controlling Pain After TKA
A Phase 4 study testing Dexamethasone Oral in people with Pain, Acute, run by Thammasat University at 1 site in Thailand.
Trial summary
To compare efficacy of oral steroid in controlling pain after TKA Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2019to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis of the knee who undergoing unilateral TKA
- ASA class I-III
- Informed consent
- Good cognitive function
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Changwat Pathum Thani, 066
supakit kanitnate, 6629260000, naypeng@hotmail.com
Nattapol Tammachote, M.D.
About this study
Official title: 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
Read the 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
- Conditions
- Pain, Acute
- Being tested
- Dexamethasone Oral
- Keywords
- oral corticosteroid, postoperative pain, dexamethasone, total knee arthroplasty
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 16 mg | Experimental | Dexamethasone (4mg) 4 tab oral once daily in the morning Receives: Drug: Dexamethasone Oral |
| Dexamethasone 8 mg | Active comparator | Dexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning Receives: Drug: Dexamethasone Oral |
| Placebo | Placebo comparator | Placebo 4 tab oral once daily in the morning Receives: Drug: Dexamethasone Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
VAS for pain (0-100) at rest and on motion
Measured: 12, 24 ,36, 48, 60 and 72 hours after surgery
Secondary outcomes (6)
nausea and vomiting
rate of nausea and vomiting
Measured: in the first 72 hours after surgery
Range of motion of the knee
Flexion and extension angle
Measured: 24, 72 hours then 2, 6, 12 weeks after surgery
Functional outcome
Modified WOMAC score
Measured: 2, 6,12 weeks after surgery
Blood sugar
Fasting blood sugar level
Measured: At 8.00 am of 1, 2, 3 days after surgery
inflammatory level
C-reactive protein level
Measured: At 8.00 am of 1, 2, 3 days and 2 weeks after surgery
Wound complications
Deep and superficial wound infection, wound dehiscense
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Sep 2019
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244695
- Sponsor's protocol ID
- OrthoTU11
- Status last verified
- Jan 2020
- First submitted
- 24 Jan 2020
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Corticosteroid in Controlling Pain After Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04244695
- Acronym / sponsor ID
- OrthoTU11
- Conditions
- Pain, Acute
- Keywords
- oral corticosteroid, postoperative pain, dexamethasone, total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone 16 mg | Experimental | Drug: Dexamethasone OralDexamethasone (4mg) 4 tab oral once daily in the morning |
| Dexamethasone 8 mg | Active comparator | Drug: Dexamethasone OralDexamethasone (4mg) 2 tab and placebo 2 tab oral once daily in the morning |
| Placebo | Placebo comparator | Drug: Dexamethasone OralPlacebo 4 tab oral once daily in the morning |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with osteoarthritis of the knee who undergoing unilateral TKA
- ASA class I-III
- Informed consent
- Good cognitive function
Key exclusion criteria (7 listed)
- Uncontrolled DM (HbA1C > 7)
- Uncontrolled HT
- Morbid obesity (BMI > 40)
- History of bleeding in GI tract
- Corticosteroid used within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone OralTo compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA | Drug | Dexamethasone 16 mg, Dexamethasone 8 mg, Placebo |
Primary outcome
Pain level
Time frame: 12, 24 ,36, 48, 60 and 72 hours after surgery
VAS for pain (0-100) at rest and on motion
6 secondary outcomes
nausea and vomiting
Time frame: 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
Functional outcome
Time frame: 2, 6,12 weeks after surgery
Blood sugar
Time frame: 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
Wound complications
Time frame: 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Oral in people with Pain, Acute, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 12, 24 ,36, 48, 60 and 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.