- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03025594
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
- Name: Barahona A Maximiliano, MD MBiostat
- Phone Number: 56 2 29788225
- Email: maxbarahonavasquez@gmail.com
Study Contact Backup
- Name: Barrientos N Cristian, MD
- Phone Number: 56 2 29788226
- Email: cristianbarrien@gmail.com
Study Locations
-
-
Region Metropolitana
-
Santiago, Region Metropolitana, Chile, 8380419
- Not yet recruiting
- Hospital San José
-
Contact:
- Martinez Alvaro, MD
- Phone Number: 962290744
- Email: martinezh.alvaro@gmail.com
-
Contact:
- barrientos n cristian
- Phone Number: 998749180
- Email: cristianbarrien@gmail.com
-
Santiago, Region Metropolitana, Chile, 8380456
- Recruiting
- Hospital Clinico Universidad de Chile
-
Contact:
- barahona a maximiliano, MD MBiostat
- Phone Number: 29788225
- Email: maxbarahonavasquez@gmail.com
-
Contact:
- barrientos n cristian, MD
- Phone Number: 29788226
- Email: cristianbarrien@gmail.com
-
-
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
|
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..
|
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
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
- Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen EK, Soballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. doi: 10.1080/17453670710013645.
- Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.
- Manriquez V, Castro Caperan D, Guzman R, Naser M, Iglesia V, Lagos N. First evidence of neosaxitoxin as a long-acting pain blocker in bladder pain syndrome. Int Urogynecol J. 2015 Jun;26(6):853-8. doi: 10.1007/s00192-014-2608-2. Epub 2015 Jan 9.
- Rodriguez-Navarro AJ, Lagos M, Figueroa C, Garcia C, Recabal P, Silva P, Iglesias V, Lagos N. Potentiation of local anesthetic activity of neosaxitoxin with bupivacaine or epinephrine: development of a long-acting pain blocker. Neurotox Res. 2009 Nov;16(4):408-15. doi: 10.1007/s12640-009-9092-3. Epub 2009 Jul 28.
- Rodriguez-Navarro AJ, Lagos N, Lagos M, Braghetto I, Csendes A, Hamilton J, Figueroa C, Truan D, Garcia C, Rojas A, Iglesias V, Brunet L, Alvarez F. Neosaxitoxin as a local anesthetic: preliminary observations from a first human trial. Anesthesiology. 2007 Feb;106(2):339-45. doi: 10.1097/00000542-200702000-00023.
- Garrido R, Lagos N, Lattes K, Abedrapo M, Bocic G, Cuneo A, Chiong H, Jensen C, Azolas R, Henriquez A, Garcia C. Gonyautoxin: new treatment for healing acute and chronic anal fissures. Dis Colon Rectum. 2005 Feb;48(2):335-40; discussion 340-3. doi: 10.1007/s10350-004-0893-4.
- Garrido R, Lagos N, Lattes K, Azolas CG, Bocic G, Cuneo A, Chiong H, Jensen C, Henriquez AI, Fernandez C. The gonyautoxin 2/3 epimers reduces anal tone when injected in the anal sphincter of healthy adults. Biol Res. 2004;37(3):395-403. doi: 10.4067/s0716-97602004000300005.
- Garcia C, del Carmen Bravo M, Lagos M, Lagos N. Paralytic shellfish poisoning: post-mortem analysis of tissue and body fluid samples from human victims in the Patagonia fjords. Toxicon. 2004 Feb;43(2):149-58. doi: 10.1016/j.toxicon.2003.11.018.
- Hinzpeter J, Barrientos C, Zamorano A, Martinez A, Palet M, Wulf R, Barahona M, Sepulveda JM, Guerra M, Bustamante T, Del Campo M, Tapia E, Lagos N. Gonyautoxins: First evidence in pain management in total knee arthroplasty. Toxicon. 2016 Sep 1;119:180-5. doi: 10.1016/j.toxicon.2016.06.010. Epub 2016 Jun 15.
- Fan L, Yu X, Zan P, Liu J, Ji T, Li G. Comparison of Local Infiltration Analgesia With Femoral Nerve Block for Total Knee Arthroplasty: A Prospective, Randomized Clinical Trial. J Arthroplasty. 2016 Jun;31(6):1361-1365. doi: 10.1016/j.arth.2015.12.028. Epub 2015 Dec 20.
- Chaumeron A, Audy D, Drolet P, Lavigne M, Vendittoli PA. Periarticular injection in knee arthroplasty improves quadriceps function. Clin Orthop Relat Res. 2013 Jul;471(7):2284-95. doi: 10.1007/s11999-013-2928-4. Epub 2013 Mar 21. Erratum In: Clin Orthop Relat Res. 2013 Jun;471(6):2042.
- Albrecht E, Guyen O, Jacot-Guillarmod A, Kirkham KR. The analgesic efficacy of local infiltration analgesia vs femoral nerve block after total knee arthroplasty: a systematic review and meta-analysis. Br J Anaesth. 2016 May;116(5):597-609. doi: 10.1093/bja/aew099.
- Moghtadaei M, Farahini H, Faiz SH, Mokarami F, Safari S. Pain Management for Total Knee Arthroplasty: Single-Injection Femoral Nerve Block versus Local Infiltration Analgesia. Iran Red Crescent Med J. 2014 Jan;16(1):e13247. doi: 10.5812/ircmj.13247. Epub 2014 Jan 5.
- Affas F, Nygards EB, Stiller CO, Wretenberg P, Olofsson C. Pain control after total knee arthroplasty: a randomized trial comparing local infiltration anesthesia and continuous femoral block. Acta Orthop. 2011 Aug;82(4):441-7. doi: 10.3109/17453674.2011.581264. Epub 2011 May 11.
- Ng FY, Chiu KY, Yan CH, Ng KF. Continuous femoral nerve block versus patient-controlled analgesia following total knee arthroplasty. J Orthop Surg (Hong Kong). 2012 Apr;20(1):23-6. doi: 10.1177/230949901202000105.
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Ketorolac
- Levobupivacaine
- Epinephrine
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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