Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty

Study Overview
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Brief Summary
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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

Official Title
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Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study

Conditions
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Knee Arthroplasty, Pain Management

Intervention / Treatment
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* Drug: Gonyautoxins
* Drug: Chirocaine ketorolac epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gonyautoxin<br>Gonyautoxin 40mcg | Drug: Gonyautoxins<br>* 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<br>|
| Active Comparator: Control<br>Mix of chirocaine 0,2%, ketorolac and epinephrine.. | Drug: Chirocaine ketorolac epinephrine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consume | total consumption of morphine at 60 hours after total knee arthroplaty | 60hrs post surgery | 
| range of motion 1 | Range of motion of the knee that underwent arthroplasty after 12 hours of surgery | 12hours post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early morphine consume | total morphine consumption during first 24 hours after total knee arthroplaty | 1 day after surgery | 
| range of motion 2 | Range of motion of the knee that underwent arthroplasty at 36 hours after surgery | 36 hours after surgery | 
| range of motion 3 | Range of motion of the knee that underwent arthroplasty at 60 hours after surgery | 60 hours after surgery | 
| time of up and go test 1 | Difference in speed when performing the up and go test, which consists of getting up from a chair walk 3 meters and return to sit in the same chair. Comparision will be made between time achieved at 24 hours after surgery compared to time achieved before surgery. | 1 day after surgery | 
| time of up and go test 2 | Difference in speed when performing the up and go test, which consists of getting up from a chair walk 3 meters and return to sit in the same chair. Comparision will be made between time achieved at 48 hours after surgery compared to time achieved before surgery. | 2 days after surgery | 
| pain visual analague scale 1 | pain visual analague scale (scale 0-10) applied at rest and post physioterapy | 12 hours post surgery | 
| pain visual analague scale 2 | pain visual analague scale (scale 0-10) applied at rest and post physioterapy | 36 hours post surgery | 
| pain visual analague scale 3 | pain visual analague scale (scale 0-10) applied at rest and post physioterapy | 60 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paralytic sellfish toxins, Gonyautoxin, Post surgery pain management, total knee arthroplasty