Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty

NCT03025594 | Unknown Phase 3 DMC

• 1 other identifier: AIC 769/15
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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

Conditions

Knee Arthroplasty; Pain Management

Keywords

Paralytic sellfish toxins; Gonyautoxin; Post surgery pain management; total knee arthroplasty

Outcome Measures

Primary Outcomes (2)

• morphine consume

  total consumption of morphine at 60 hours after total knee arthroplaty

  60hrs post surgery

• range of motion 1

  Range of motion of the knee that underwent arthroplasty after 12 hours of surgery

  12hours post surgery

Secondary Outcomes (8)

• early morphine consume

  1 day after surgery

• range of motion 2

  36 hours after surgery

• range of motion 3

  60 hours after surgery

• time of up and go test 1

  1 day after surgery

• time of up and go test 2

  2 days after surgery

Study Arms (2)

Gonyautoxin

EXPERIMENTAL

Gonyautoxin 40mcg

Drug: Gonyautoxins

Control

ACTIVE COMPARATOR

Mix of chirocaine 0,2%, ketorolac and epinephrine..

Drug: Chirocaine ketorolac epinephrine

Interventions

Gonyautoxins DRUG

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

Gonyautoxin

Chirocaine ketorolac epinephrine DRUG

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.

Control

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• maximiliano barahona vasquez: lead

Study Sites (2)

Hospital San Jose

Santiago, Santiago Metropolitan, 8380419, Chile

NOT YET RECRUITING

hospital Clinico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

RECRUITING

Related Publications (15)

• 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.

  PMID: 25571865 BACKGROUND

• 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.

  PMID: 19636660 BACKGROUND

• 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.

  PMID: 17264729 BACKGROUND

• 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.

  PMID: 15812585 BACKGROUND

• 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.

  PMID: 15515965 BACKGROUND

• 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.

  PMID: 15019474 BACKGROUND

• 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.

  PMID: 27317871 RESULT

• 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.

  PMID: 26810604 RESULT

• 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.

  PMID: 23516031 RESULT

• 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.

  PMID: 24939863 RESULT

• 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.

  PMID: 27106963 RESULT

• 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.

  PMID: 17464603 RESULT

• 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.

  PMID: 24719708 RESULT

• 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.

  PMID: 21561303 RESULT

• 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.

  PMID: 22535806 RESULT

MeSH Terms

Conditions

Agnosia

Interventions

gonyautoxins

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hinzpeter R Jaime, MD

  orthopaedic surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barahona A Maximiliano, MD MBiostat

CONTACT

56 2 29788225; maxbarahonavasquez@gmail.com

Barrientos N Cristian, MD

CONTACT

56 2 29788226; cristianbarrien@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MBiostat

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 19, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

CL (2)