A Phase 3 interventional study of Gonyautoxins and Chirocaine ketorolac epinephrine in Knee Arthroplasty and Pain Management, sponsored by maximiliano barahona vasquez. Status unknown at 2 sites in Chile. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-24.
Sponsored by maximiliano barahona vasquez · Phase 3, Interventional, and Treatment
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
This is the only study on the registry with maximiliano barahona vasquez as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Gonyautoxin 40mcg
Drug: Gonyautoxins
Mix of chirocaine 0,2%, ketorolac and epinephrine..
Drug: Chirocaine ketorolac epinephrine
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
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.
morphine consume
total consumption of morphine at 60 hours after total knee arthroplaty
Time frame: 60hrs post surgery
range of motion 1
Range of motion of the knee that underwent arthroplasty after 12 hours of surgery
Time frame: 12hours post surgery
early morphine consume
total morphine consumption during first 24 hours after total knee arthroplaty
Time frame: 1 day after surgery
range of motion 2
Range of motion of the knee that underwent arthroplasty at 36 hours after surgery
Time frame: 36 hours after surgery
range of motion 3
Range of motion of the knee that underwent arthroplasty at 60 hours after surgery
Time frame: 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.
Time frame: 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.
Time frame: 2 days after surgery
pain visual analague scale 1
pain visual analague scale (scale 0-10) applied at rest and post physioterapy
Time frame: 12 hours post surgery
pain visual analague scale 2
pain visual analague scale (scale 0-10) applied at rest and post physioterapy
Time frame: 36 hours post surgery
pain visual analague scale 3
pain visual analague scale (scale 0-10) applied at rest and post physioterapy
Time frame: 60 hours post surgery
Plan to share: Yes — First, a formal letter must be send to the Ethical Committee of Hospital Clinico Universidad de Chile. If the committee gives its consent, the principal investigator will send IPD to whom request it.
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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