Postoperative PainPhase 4NCT02001259
Efficacy of Epidural Steroid for Controlling Pain After Primary TKA
A Phase 4 study testing epidural triamsinolone and epidural lidocaine in people with Postoperative Pain, run by Thammasat University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine efficacy of epidural steroid 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?
- epidural triamsinolone and epidural lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to Oct 2015
- 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 epidural anaesthesia
- history of drug allergies: lidocaine, steroid
- renal impairment (CrCl <30 mL/min)
- liver impairment
- cognitive function disorders
- displacement of epidural catheter
Trial locations and contacts
1 site in 1 country.
Thailand1 site
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Changwat Pathum Thani, 066
About this study
Official title: Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA
Read the detailed description
Epidural triamsinolone can reduce postoperative pain and longer duration of pain control after TKA
- Conditions
- Postoperative Pain
- Being tested
- epidural triamsinolone, epidural lidocaine
- Keywords
- post-operative pain control, total knee arthroplasty, epidural steroid injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural triamsinoloneDrug
Also called epidural steroid
add drugs into catheter at 48 hr after surgery
epidural lidocaineDrug
Also called epidural xylocaine
add into catheter at 48 hr after surgery
| Study group | Role | What they receive |
|---|---|---|
| Epidural lidocaine | Active comparator | epidural lidocaine: 3 mL of 1% lidocaine with adrenaline and 3 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery Receives: Drug: epidural lidocaine |
| epidural triamsinolone | Experimental | epidural triamsinolone: 40 mg of triamsinolone (1 mL), 2.5 mL of 1% lidocaine with adrenaline and 2.5 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery Receives: Drug: epidural triamsinolone |
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 (VAS at rest and on motion)
Measured: 3 months
Secondary outcomes (1)
functional knee score
measured with WOMAC
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionOct 2015
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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 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, orthopaedic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001259
- Sponsor's protocol ID
- orthoTU05
- Status last verified
- May 2017
- First submitted
- 27 Nov 2013
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Epidural Steroid in Controlling Postoperative Pain After Primary Total Knee Arthroplasty: A Randomized Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT02001259
- Acronym / sponsor ID
- orthoTU05
- Conditions
- Postoperative Pain
- Keywords
- post-operative pain control, total knee arthroplasty, epidural steroid injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Dec 2013 (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.
The purpose of this study is to determine efficacy of epidural steroid for postoperative pain control after TKA
Detailed description
Epidural triamsinolone can reduce postoperative pain and longer duration of pain control after TKA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural lidocaine | Active comparator | Drug: epidural lidocaineepidural lidocaine: 3 mL of 1% lidocaine with adrenaline and 3 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery |
| epidural triamsinolone | Experimental | Drug: epidural triamsinoloneepidural triamsinolone: 40 mg of triamsinolone (1 mL), 2.5 mL of 1% lidocaine with adrenaline and 2.5 mL of 1% lidocaine without adrenaline into epidural catheter at 48 hr after surgery |
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 (6 listed)
- unable to perform epidural anaesthesia
- history of drug allergies: lidocaine, steroid
- 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 |
|---|---|---|
| epidural triamsinoloneAlso: epidural steroidadd drugs into catheter at 48 hr after surgery | Drug | epidural triamsinolone |
| epidural lidocaineAlso: epidural xylocaineadd into catheter at 48 hr after surgery | Drug | Epidural lidocaine |
Primary outcome
post-operative pain
Time frame: 3 months
measured with VAS for pain (VAS at rest and on motion)
1 secondary outcome
functional knee score
Time frame: 3 months
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 9 May 2017.
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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
orthopaedic department
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 epidural triamsinolone and epidural lidocaine 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 6 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 9 May 2017. 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. 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: 3 months). 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 9 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.