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Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study (NCT03025594)

The aim of this study is to demostrate the eficcacy in pain control management after total knee arthroplasty of Gonyautoxin. Local administration during surgery of Gonyautoxin before wound closure can achieved better pain control and lower morphin use during hospital stay compared to local administration of chirocaine, ketorolac and epinephrine
  • Drug: Gonyautoxins
    Periarticular infiltration of 40mcg of Gonyautoxin diluted in 30cc of Sodium Chloride 0.9%, with pH 6.2 and isosmotic. This solution will be administer targeting posterior capsule, both retinaculum, collateral ligaments, quadriceps and patelar tendon and subcutaneous tissue just before wound closure of total knee arhroplasty
    • Drug: Chirocaine ketorolac epinephrine
      Periarticular infiltration of 150ml of Chirocaine 2%, 60mg of ketorolac and 0.75mg of epinephrine. This solution will be administer targeting posterior capsule, both retinaculum, collateral ligaments, quadriceps and patelar tendon and subcutaneous tissue jbefore wound closure of total knee arhroplasty.
      Ages eligible for Study
      up to 80 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Patients who required total knee arthroplasty due to knee osteoarthritis ( Kellgren and Lawrence score of 2 or more), with no response to conservative management.
      • Without known allergies to the drugs used in the study
      • Anesthetic risk: ASA Score 1,2,3.
      Exclusion Criteria:
      • Obesity, defined as body Mass index over 35
      • Previous Knee surgery
      • Mellitus diabetes
      • Organic brain damage
      • Rheumatic Arthritis
      • Coagulation deficit
      • Liver disease
      • Chronic obstructive pulmonary disease
      • Chronic consumption of opiods
      • Refusal to participate in the study

      2 locations

      Chile (2)
      • Hospital San Jose
        not yet recruiting
        Santiago, Region Metropolitana, Chile, 8380419
      • hospital Clinico Universidad de Chile
        recruiting
        Santiago, Region Metropolitana, Chile, 8380456
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      Start:
      31 December, 2016
      Updated:
      22 January, 2017
      Participants:
      64
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