Preemptive Analgesia in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: Celecoxib and Pregabaline
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 55-80 years old patients who come to orthopaedic polyclinic underwent TKA procedure have osteoarthritis consumed pain killer and anti inflamatory drugs routinely Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>celecoxib 400mg and pregabaline 150mg 1 hour before operation | Drug: Celecoxib and Pregabaline<br>* Single dose versus repetition dose<br>|
| Active Comparator: Group 2<br>celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation | Drug: Celecoxib and Pregabaline<br>* Single dose versus repetition dose<br>|
| Placebo Comparator: Group 3<br>No treatment given | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Morphine Consumption | In this study, morphine is given by patient control analgesia (PCA). | Third day post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | every morning [daily], up to 3 days | 
| Mobilization | The patient is expected to be able to do sitting motion | on the first day, standing on the second day, and walking on the third day |