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Preemptive Analgesia in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523832
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Fakultas Kedokteran Universitas Indonesia

Study Description
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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


Condition or disease Intervention/treatment Phase
Acute Pain Drug: Celecoxib and Pregabaline Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1
celecoxib 400mg and pregabaline 150mg 1 hour before operation
 Drug: Celecoxib and Pregabaline
Single dose versus repetition dose
Active Comparator: Group 2
celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation
 Drug: Celecoxib and Pregabaline
Single dose versus repetition dose
Placebo Comparator: Group 3
No treatment given
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Total Morphine Consumption [ Time Frame: Third day post-operative ]
    In this study, morphine is given by patient control analgesia (PCA).


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
  Study Documents (Full-Text)

Documents provided by Fakultas Kedokteran Universitas Indonesia:
Study Protocol and Statistical Analysis Plan  [PDF] May 10, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT03523832    
Other Study ID Numbers: 04
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Celecoxib
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors