Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty
NCT ID: NCT03025594
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
64 participants
INTERVENTIONAL
2017-01-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gonyautoxin
Gonyautoxin 40mcg
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
Control
Mix of chirocaine 0,2%, ketorolac and epinephrine..
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* Without known allergies to the drugs used in the study
* Anesthetic risk: ASA Score 1,2,3.
Exclusion Criteria
* 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
80 Years
ALL
No
Sponsors
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maximiliano barahona vasquez
OTHER
Responsible Party
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maximiliano barahona vasquez
MD, MBiostat
Principal Investigators
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Hinzpeter R Jaime, MD
Role: PRINCIPAL_INVESTIGATOR
orthopaedic surgeon
Locations
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Hospital San Jose
Santiago, Santiago Metropolitan, Chile
hospital Clinico Universidad de Chile
Santiago, Santiago Metropolitan, Chile
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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AIC 769/15
Identifier Type: -
Identifier Source: org_study_id
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