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Completed

NCT Number: NCT03523832

Preemptive Analgesia in Total Knee Arthroplasty

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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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib and Pregabaline

Drug

Single dose versus repetition dose

Placebo

Other

Placebo

Primary outcomes

  1. Total Morphine Consumption

    Time frame: Third day post-operative

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

Secondary outcomes

  1. Post-operative Pain

    Time frame: 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.

  2. Knee functional outcome

    Time frame: 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.

  3. Mobilization

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fakultas Kedokteran Universitas Indonesia

Other

Registry information

Official study title

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)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 14, 2018
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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