Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty

maximiliano barahona vasquez64 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Knee Arthroplasty Pain Management

Interventions

GonyautoxinsDRUG

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

Chirocaine ketorolac epinephrineDRUG

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.

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital San Jose

Santiago, Santiago Metropolitan, Chile

NOT_YET_RECRUITING

hospital Clinico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Barahona A Maximiliano, MD MBiostat

CONTACT

56 2 29788225 maxbarahonavasquez@gmail.com

Barrientos N Cristian, MD

CONTACT

56 2 29788226 cristianbarrien@gmail.com

Data from ClinicalTrials.gov

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