Postoperative PainPhase 4TKANCT02102815
Efficacy of Preoperative Intravenous Dexamethasone in Primary Total Knee Arthroplasty
A Phase 4 study testing Dexamethasone and Normal saline in people with Postoperative Pain, run by Thammasat University at 1 site in Thailand.
Trial summary
To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to Jun 2016
- 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
- Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- 50-85 years old
- ASA class 1-3
Who cannot join
- Unable to perform spinal anaesthesia
- History of drug allergies: steroids
- Renal impairment (CrCl <30 mL/min)
- Liver impairment
- Cognitive function disorders
- Poor controlled DM (HA1C > 7.5)
- Morning DTX at operative day > 180 mg%
- Received corticosteroids within 3 months before surgery
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Orthopaedic department, Faculty of medicine, Thammasat university
Klongluang, Changwat Pathum Thani, 066
About this study
Official title: Efficacy of Preoperative Intravenous Dexamethasone in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
To determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.
Read the detailed description
Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Normal saline
- Keywords
- total knee arthroplasty, pain control, dexamethasone, steroids
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes
Normal salineDrug
NSS 50 mL IV slowly push over 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Preoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Preoperative intravenous normal saline 50 mL slowly push over 5 minutes Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative pain
measured with VAS for pain, drugs for relief pain
Measured: 48 hours
Secondary outcomes (4)
Functional knee score
measured with WOMAC, KSS
Measured: 3 month
post-operative nausea and vomiting
measured with amount of nausea/vomiting and drugs requiring for fixed its.
Measured: 48 hours
complication of preoperative dexamethasone
measured with wound complication, blood sugar level
Measured: 2 weeks
inflammatory level
CRP level
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
- Investigators
- Supakit Kanitnate, M.D., Principal investigator, Orthopaedics department, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102815
- Sponsor's protocol ID
- OrthoTU06
- Acronym
- TKA
- Status last verified
- Jan 2019
- First submitted
- 31 Mar 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Intravenous Dexamethasone in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT02102815
- Acronym / sponsor ID
- TKA / OrthoTU06
- Conditions
- Postoperative Pain
- Keywords
- total knee arthroplasty, pain control, dexamethasone, steroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Apr 2014 (estimated)
- 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 determine efficacy of preoperative IV dexamethasone for postoperative pain control after TKA.
Detailed description
Preoperative intravenous over 0.1 mg/kg of dexamethasone could be reduced pain after primary TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasonePreoperative dexamethasone 0.15mg/Kg mixed with NSS to 50 mL IV slowly push over 5 minutes |
| Placebo | Placebo comparator | Drug: Normal salinePreoperative intravenous normal saline 50 mL slowly push over 5 minutes |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- 50-85 years old
- ASA class 1-3
Key exclusion criteria (8 listed)
- Unable to perform spinal anaesthesia
- History of drug allergies: steroids
- Renal impairment (CrCl <30 mL/min)
- Liver impairment
- Cognitive function disorders
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 |
|---|---|---|
| DexamethasoneDexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes | Drug | Dexamethasone |
| Normal salineNSS 50 mL IV slowly push over 5 minutes | Drug | Placebo |
Primary outcome
post-operative pain
Time frame: 48 hours
measured with VAS for pain, drugs for relief pain
4 secondary outcomes
Functional knee score
Time frame: 3 month
post-operative nausea and vomiting
Time frame: 48 hours
complication of preoperative dexamethasone
Time frame: 2 weeks
inflammatory level
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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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.
Supakit Kanitnate, M.D. principal investigator
Orthopaedics department, Thammasat University
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 and Normal saline in people with Postoperative Pain, 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative pain (time frame: 48 hours). 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 15 Jan 2019.