Clinical trial NCT03025594: Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty
Official title: Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Knee Arthroplasty
Pain Management
Keywords: Paralytic sellfish toxins
Gonyautoxin
Post surgery pain management
total knee arthroplasty
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 64
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: morphine consume
timeFrame: 60hrs post surgery
measure: range of motion 1
timeFrame: 12hours post surgery
Secondary outcomes:
measure: early morphine consume
timeFrame: 1 day after surgery
measure: range of motion 2
timeFrame: 36 hours after surgery
measure: range of motion 3
timeFrame: 60 hours after surgery
measure: time of up and go test 1
timeFrame: 1 day after surgery
measure: time of up and go test 2
timeFrame: 2 days after surgery
measure: pain visual analague scale 1
timeFrame: 12 hours post surgery
measure: pain visual analague scale 2
timeFrame: 36 hours post surgery
measure: pain visual analague scale 3
timeFrame: 60 hours post surgery
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital San Jose
state: Region Metropolitana
city: Santiago
country: Chile
facility: hospital Clinico Universidad de Chile
state: Region Metropolitana
Study officials:
affiliation: orthopaedic surgeon
name: Hinzpeter R Jaime, MD
role: PRINCIPAL_INVESTIGATOR
References:
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