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

January 23, 2017 updated by: maximiliano barahona vasquez

Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8380419
      • Santiago, Region Metropolitana, Chile, 8380456

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gonyautoxin
Gonyautoxin 40mcg
Drug: Gonyautoxins
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
Active Comparator: Control
Mix of chirocaine 0,2%, ketorolac and epinephrine..
Drug: Chirocaine 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphine consume
Time Frame: 60hrs post surgery
total consumption of morphine at 60 hours after total knee arthroplaty
60hrs post surgery
range of motion 1
Time Frame: 12hours post surgery
Range of motion of the knee that underwent arthroplasty after 12 hours of surgery
12hours post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
early morphine consume
Time Frame: 1 day after surgery
total morphine consumption during first 24 hours after total knee arthroplaty
1 day after surgery
range of motion 2
Time Frame: 36 hours after surgery
Range of motion of the knee that underwent arthroplasty at 36 hours after surgery
36 hours after surgery
range of motion 3
Time Frame: 60 hours after surgery
Range of motion of the knee that underwent arthroplasty at 60 hours after surgery
60 hours after surgery
time of up and go test 1
Time Frame: 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.
1 day after surgery
time of up and go test 2
Time Frame: 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.
2 days after surgery
pain visual analague scale 1
Time Frame: 12 hours post surgery
pain visual analague scale (scale 0-10) applied at rest and post physioterapy
12 hours post surgery
pain visual analague scale 2
Time Frame: 36 hours post surgery
pain visual analague scale (scale 0-10) applied at rest and post physioterapy
36 hours post surgery
pain visual analague scale 3
Time Frame: 60 hours post surgery
pain visual analague scale (scale 0-10) applied at rest and post physioterapy
60 hours post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

maximiliano barahona vasquez

Investigators

  • Principal Investigator: Hinzpeter R Jaime, MD, Orthopaedic Surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

January 17, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIC 769/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

First, a formal letter must be send to the Ethical Committee of Hospital Clinico Universidad de Chile. If the committee gives its consent, the principal investigator will send IPD to whom request it.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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