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Preemptive Analgesia in Total Knee Arthroplasty

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Celecoxib and Pregabaline
Placebo
Sponsored by
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm Description

    celecoxib 400mg and pregabaline 150mg 1 hour before operation

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

    No treatment given

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Post-operative Pain
    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
    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
    The patient is expected to be able to do sitting motion

    Full Information

    First Posted
    April 17, 2018
    Last Updated
    August 5, 2019
    Sponsor
    Fakultas Kedokteran Universitas Indonesia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03523832
    Brief Title
    Preemptive Analgesia in Total Knee Arthroplasty
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    December 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fakultas Kedokteran Universitas Indonesia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    celecoxib 400mg and pregabaline 150mg 1 hour before operation
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    celecoxib 200mg and pregabaline 75mg twice daily started from 3 days before operation
    Arm Title
    Group 3
    Arm Type
    Placebo Comparator
    Arm Description
    No treatment given
    Intervention Type
    Drug
    Intervention Name(s)
    Celecoxib and Pregabaline
    Intervention Description
    Single dose versus repetition dose
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Total Morphine Consumption
    Description
    In this study, morphine is given by patient control analgesia (PCA).
    Time Frame
    Third day post-operative
    Secondary Outcome Measure Information:
    Title
    Post-operative Pain
    Description
    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.
    Time Frame
    every morning [daily], up to 3 days
    Title
    Knee functional outcome
    Description
    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.
    Time Frame
    every morning [daily], up to 3 days
    Title
    Mobilization
    Description
    The patient is expected to be able to do sitting motion
    Time Frame
    on the first day, standing on the second day, and walking on the third day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30174951
    Citation
    Lubis AMT, Rawung RBV, Tantri AR. Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial. Pain Res Treat. 2018 Aug 7;2018:3807217. doi: 10.1155/2018/3807217. eCollection 2018.
    Results Reference
    derived

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    Preemptive Analgesia in Total Knee Arthroplasty

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