Preemptive Analgesia in Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2016-12-31

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

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Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1

celecoxib 400mg and pregabaline 150mg 1 hour before operation

Group Type ACTIVE_COMPARATOR

Celecoxib and Pregabaline

Intervention Type DRUG

Single dose versus repetition dose

Group 2

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

Group Type ACTIVE_COMPARATOR

Celecoxib and Pregabaline

Intervention Type DRUG

Single dose versus repetition dose

Group 3

No treatment given

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Celecoxib and Pregabaline

Single dose versus repetition dose

Intervention Type DRUG

Placebo

Intervention Type OTHER

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes