Preemptive Analgesia in Total Knee Arthroplasty

Phase 2

Completed

• Conditions: Acute Pain
• Interventions: Drug: Celecoxib and Pregabaline; Other: Placebo

• Registration Number: NCT03523832
• Lead Sponsor: Fakultas Kedokteran Universitas Indonesia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-31
• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-05-10
• Study First Posted: 2018-05-14
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 1	Celecoxib and Pregabaline	celecoxib 400mg and pregabaline 150mg 1 hour before operation
Group 2	Celecoxib and Pregabaline	celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation
Group 3	Placebo	No treatment given

Primary Outcome Measures

Name	Time	Method
Total Morphine Consumption	Third day post-operative	In this study, morphine is given by patient control analgesia (PCA).

Secondary Outcome Measures

Name	Time	Method
Post-operative Pain	every morning [daily], up to 3 days	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.
Knee functional outcome	every morning [daily], up to 3 days	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.
Mobilization	on the first day, standing on the second day, and walking on the third day	The patient is expected to be able to do sitting motion