Preemptive Analgesia in Total Knee Arthroplasty

University of Indonesia (UI)

Status and phase: Completed; Phase 2

Conditions: Acute Pain

Treatments: Other: Placebo; Drug: Celecoxib and Pregabaline

Study type: Interventional

Funder types: Other

Identifiers

NCT03523832

04

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

celecoxib 400mg and pregabaline 150mg 1 hour before operation

Treatment:

Drug: Celecoxib and Pregabaline

Group 2

Active Comparator group

Description:

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

Treatment:

Drug: Celecoxib and Pregabaline

Group 3

Placebo Comparator group

Description:

No treatment given

Treatment:

Other: Placebo