Acute PainPhase 2NCT03523832
Preemptive Analgesia in Total Knee Arthroplasty
A Phase 2 study testing Celecoxib and Pregabaline in people with Acute Pain, run by Fakultas Kedokteran Universitas Indonesia.
Trial summary
Acute Pain is the most common early complication after total knee arthroplasty that caused delayed mobilization, demands of morphine, and higher operative cost. There were many researches that had been done in analgesia method to find the most effective analgesia, lowest side effect, and easy to apply. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- Celecoxib and Pregabaline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 31 Dec 2016
- Phase
- Phase 2
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55-80 years old patients who come to orthopaedic polyclinic
- underwent TKA procedure
- have osteoarthritis
- consumed pain killer and anti inflamatory drugs routinely
Who cannot join
- psychiatric disorder
- have history of renal disease
- histroy of chronic neurophatic
- have genu arthritis that caused by rheumatid arthritis and infection
- diabetic and obesity
- coagulopathy
- patients with severe pain that needed immediate analgesia regimen
About this study
Official title: Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combined Celecoxib With Pregabaline and Repetition Dose Combined Celecoxib With Pregabaline (Double Blind Controlled Clinical Trial)
Acute Pain is the most common early complication after total knee arthroplasty that caused delayed mobilization, demands of morphine, and higher operative cost. There were many researches that had been done in analgesia method to find the most effective analgesia, lowest side effect, and easy to apply. Preemptive analgesia of combined celecoxib and pregabalin were reported to give a promising outcome.
In a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. First group was given celecoxib 400mg and pregabaline 150mg 1 hour before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation, and the last group was given placebo. The outcome was measured with VAS, knee ROM, and post-operative mobilization
- Conditions
- Acute Pain
- Being tested
- Celecoxib and Pregabaline, Placebo
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celecoxib and PregabalineDrug
Single dose versus repetition dose
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | celecoxib 400mg and pregabaline 150mg 1 hour before operation Receives: Drug: Celecoxib and Pregabaline |
| Group 2 | Active comparator | celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation Receives: Drug: Celecoxib and Pregabaline |
| Group 3 | Placebo comparator | No treatment given Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine Consumption
In this study, morphine is given by patient control analgesia (PCA).
Measured: Third day post-operative
Secondary outcomes (3)
Post-operative Pain
Measured and evaluated by Visual Analogue Scale (VAS). VAS score of 1-10. With the maximal of 10. Ranging from no pain to unbearable pain. Worst pain is in score 10.
Measured: every morning [daily], up to 3 days
Knee functional outcome
Measured by active knee range of motion using goniometer. The outcome scale is in degree range of motion. The knee range of motion is 0 degree (total extension) to 135 degree (full flexion). The more range of motion degree, the better the result.
Measured: every morning [daily], up to 3 days
Mobilization
The patient is expected to be able to do sitting motion
Measured: on the first day, standing on the second day, and walking on the third day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start1 Jul 2015
- Primary completion1 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fakultas Kedokteran Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523832
- Sponsor's protocol ID
- 04
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 6 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lubis AMT, Rawung RBV, Tantri AR. Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial. Pain Res Treat. 2018 Aug 7;2018:3807217. doi: 10.1155/2018/3807217. eCollection 2018.
PubMed 30174951
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combined Celecoxib With Pregabaline and Repetition Dose Combined Celecoxib With Pregabaline (Double Blind Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT03523832
- Acronym / sponsor ID
- 04
- Conditions
- Acute Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 14 May 2018 (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.
Acute Pain is the most common early complication after total knee arthroplasty that caused delayed mobilization, demands of morphine, and higher operative cost. There were many researches that had been done in analgesia method to find the most effective analgesia, lowest side effect, and easy to apply. Preemptive analgesia of combined celecoxib and pregabalin were reported to give a promising outcome.
In a randomized, double blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. First group was given celecoxib 400mg and pregabaline 150mg 1 hour before operation, second group was given celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation, and the last group was given placebo. The outcome was measured with VAS, knee ROM, and post-operative mobilization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Celecoxib and Pregabalinecelecoxib 400mg and pregabaline 150mg 1 hour before operation |
| Group 2 | Active comparator | Drug: Celecoxib and Pregabalinecelecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation |
| Group 3 | Placebo comparator | Other: PlaceboNo treatment given |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 55-80 years old patients who come to orthopaedic polyclinic
- underwent TKA procedure
- have osteoarthritis
- consumed pain killer and anti inflamatory drugs routinely
Key exclusion criteria (7 listed)
- psychiatric disorder
- have history of renal disease
- histroy of chronic neurophatic
- have genu arthritis that caused by rheumatid arthritis and infection
- diabetic and obesity
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 |
|---|---|---|
| Celecoxib and PregabalineSingle dose versus repetition dose | Drug | Group 1, Group 2 |
| PlaceboPlacebo | Other | Group 3 |
Primary outcome
Total Morphine Consumption
Time frame: Third day post-operative
In this study, morphine is given by patient control analgesia (PCA).
3 secondary outcomes
Post-operative Pain
Time frame: every morning [daily], up to 3 days
Knee functional outcome
Time frame: every morning [daily], up to 3 days
Mobilization
Time frame: on the first day, standing on the second day, and walking on the third day
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 6 Aug 2019.
- Derived from this study: PubMed 30174951Lubis AMT, Rawung RBV, Tantri AR. Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial. Pain Res Treat. 2018 Aug 7;2018:3807217. doi: 10.1155/2018/3807217. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib and Pregabaline in people with Acute Pain, run by Fakultas Kedokteran Universitas Indonesia.
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: finished, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Total Morphine Consumption (time frame: Third day post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03523832, which also lists 1 linked publication.
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 6 Aug 2019.