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

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ClinicalTrials.gov Identifier: NCT03025594
Recruitment Status : Unknown
Verified January 2017 by maximiliano barahona vasquez, University of Chile.
Recruitment status was:  Recruiting
First Posted : January 19, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
maximiliano barahona vasquez, University of Chile

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

Condition or disease Intervention/treatment Phase
Knee Arthroplasty Pain Management Drug: Gonyautoxins Drug: Chirocaine ketorolac epinephrine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study
Study Start Date : January 2017
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. morphine consume [ Time Frame: 60hrs post surgery ]
    total consumption of morphine at 60 hours after total knee arthroplaty

  2. range of motion 1 [ Time Frame: 12hours post surgery ]
    Range of motion of the knee that underwent arthroplasty after 12 hours of surgery


Secondary Outcome Measures :
  1. early morphine consume [ Time Frame: 1 day after surgery ]
    total morphine consumption during first 24 hours after total knee arthroplaty

  2. range of motion 2 [ Time Frame: 36 hours after surgery ]
    Range of motion of the knee that underwent arthroplasty at 36 hours after surgery

  3. range of motion 3 [ Time Frame: 60 hours after surgery ]
    Range of motion of the knee that underwent arthroplasty at 60 hours after surgery

  4. 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.

  5. 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.

  6. pain visual analague scale 1 [ Time Frame: 12 hours post surgery ]
    pain visual analague scale (scale 0-10) applied at rest and post physioterapy

  7. pain visual analague scale 2 [ Time Frame: 36 hours post surgery ]
    pain visual analague scale (scale 0-10) applied at rest and post physioterapy

  8. pain visual analague scale 3 [ Time Frame: 60 hours post surgery ]
    pain visual analague scale (scale 0-10) applied at rest and post physioterapy



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025594


Contacts
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Contact: Barahona A Maximiliano, MD MBiostat 56 2 29788225 maxbarahonavasquez@gmail.com
Contact: Barrientos N Cristian, MD 56 2 29788226 cristianbarrien@gmail.com

Locations
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Chile
Hospital San Jose Not yet recruiting
Santiago, Region Metropolitana, Chile, 8380419
Contact: Martinez Alvaro, MD    962290744    martinezh.alvaro@gmail.com   
Contact: barrientos n cristian    998749180    cristianbarrien@gmail.com   
hospital Clinico Universidad de Chile Recruiting
Santiago, Region Metropolitana, Chile, 8380456
Contact: barahona a maximiliano, MD MBiostat    29788225    maxbarahonavasquez@gmail.com   
Contact: barrientos n cristian, MD    29788226    cristianbarrien@gmail.com   
Sponsors and Collaborators
maximiliano barahona vasquez
Investigators
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Principal Investigator: Hinzpeter R Jaime, MD orthopaedic surgeon

Publications of Results:

Other Publications:

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Responsible Party: maximiliano barahona vasquez, MD, MBiostat, University of Chile
ClinicalTrials.gov Identifier: NCT03025594     History of Changes
Other Study ID Numbers: AIC 769/15
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by maximiliano barahona vasquez, University of Chile:
Paralytic sellfish toxins
Gonyautoxin
Post surgery pain management
total knee arthroplasty
Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Epinephrine
Racepinephrine
Levobupivacaine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anesthetics, Local