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Clinical Trials/NCT03523832
NCT03523832
Completed
Phase 2

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)

Fakultas Kedokteran Universitas Indonesia0 sites30 target enrollmentJuly 1, 2015

Overview

Phase
Phase 2
Intervention
Celecoxib and Pregabaline
Conditions
Acute Pain
Sponsor
Fakultas Kedokteran Universitas Indonesia
Enrollment
30
Primary Endpoint
Total Morphine Consumption
Status
Completed
Last Updated
6 years ago

Overview

Brief 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. 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

Registry
clinicaltrials.gov
Start Date
July 1, 2015
End Date
December 31, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Group 1

celecoxib 400mg and pregabaline 150mg 1 hour before operation

Intervention: Celecoxib and Pregabaline

Group 2

celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation

Intervention: Celecoxib and Pregabaline

Group 3

No treatment given

Intervention: Placebo

Outcomes

Primary Outcomes

Total Morphine Consumption

Time Frame: Third day post-operative

In this study, morphine is given by patient control analgesia (PCA).

Secondary Outcomes

  • Post-operative Pain(every morning [daily], up to 3 days)
  • Knee functional outcome(every morning [daily], up to 3 days)
  • Mobilization(on the first day, standing on the second day, and walking on the third day)

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