Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty (Toxin)

maximiliano barahona vasquez

Status and phase: Unknown; Phase 3

Conditions: Knee Arthroplasty; Pain Management

Treatments: Drug: Chirocaine ketorolac epinephrine; Drug: Gonyautoxins

Study type: Interventional

Funder types: Other

Identifiers

NCT03025594

AIC 769/15

Details and patient eligibility

About

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

Enrollment: 64 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Gonyautoxin

Experimental group

Description:

Gonyautoxin 40mcg

Treatment:

Drug: Gonyautoxins

Control

Active Comparator group

Description:

Mix of chirocaine 0,2%, ketorolac and epinephrine..

Treatment:

Drug: Chirocaine ketorolac epinephrine