Knee Arthroplasty, Pain Management
Conditions
Keywords
Paralytic sellfish toxins, Gonyautoxin, Post surgery pain management, total knee arthroplasty
Brief summary
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
Interventions
DRUGGonyautoxins
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
DRUGChirocaine 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.
Sponsors
maximiliano barahona vasquez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morphine consume | 60hrs post surgery | total consumption of morphine at 60 hours after total knee arthroplaty |
| range of motion 1 | 12hours post surgery | Range of motion of the knee that underwent arthroplasty after 12 hours of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| range of motion 3 | 60 hours after surgery | Range of motion of the knee that underwent arthroplasty at 60 hours after surgery |
| time of up and go test 1 | 1 day after surgery | 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 of up and go test 2 | 2 days after surgery | 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. |
| early morphine consume | 1 day after surgery | total morphine consumption during first 24 hours after total knee arthroplaty |
| pain visual analague scale 2 | 36 hours post surgery | pain visual analague scale (scale 0-10) applied at rest and post physioterapy |
| pain visual analague scale 3 | 60 hours post surgery | pain visual analague scale (scale 0-10) applied at rest and post physioterapy |
| pain visual analague scale 1 | 12 hours post surgery | pain visual analague scale (scale 0-10) applied at rest and post physioterapy |
| range of motion 2 | 36 hours after surgery | Range of motion of the knee that underwent arthroplasty at 36 hours after surgery |
Countries
Chile
Contacts
Primary ContactBarahona A Maximiliano, MD MBiostat
Backup ContactBarrientos N Cristian, MD
Outcome results
None listed