Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty

Phase 3

• Conditions: Knee Arthroplasty; Pain Management
• Interventions: Drug: Chirocaine ketorolac epinephrine; Drug: Gonyautoxins

• Registration Number: NCT03025594
• Lead Sponsor: maximiliano barahona vasquez

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-17
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-19
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Chirocaine ketorolac epinephrine	Mix of chirocaine 0,2%, ketorolac and epinephrine..
Gonyautoxin	Gonyautoxins	Gonyautoxin 40mcg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
range of motion 2	36 hours after surgery	Range of motion of the knee that underwent arthroplasty at 36 hours after 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.
pain visual analague scale 1	12 hours post surgery	pain visual analague scale (scale 0-10) applied at rest and post physioterapy
pain visual analague scale 2	36 hours post surgery	pain visual analague scale (scale 0-10) applied at rest and post physioterapy
early morphine consume	1 day after surgery	total morphine consumption during first 24 hours after total knee arthroplaty
range of motion 3	60 hours after surgery	Range of motion of the knee that underwent arthroplasty at 60 hours after surgery
pain visual analague scale 3	60 hours post surgery	pain visual analague scale (scale 0-10) applied at rest and post physioterapy
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.

Trial Locations

Locations (2)

Hospital San Jose; 🇨🇱 Santiago, Region Metropolitana, Chile

hospital Clinico Universidad de Chile; 🇨🇱 Santiago, Region Metropolitana, Chile