Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty

Pain Management Clinical Trial

— Toxin  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03025594
• Other study ID #: AIC 769/15
• Status: Recruiting
• Phase: Phase 3
• First received: January 17, 2017
• Last updated: January 23, 2017
• Start date: January 2017
• Est. completion date: August 2017

Study information

• Verified date: January 2017
• Source: University of Chile
• Contact: Barahona A Maximiliano, MD MBiostat
• Phone: 56 2 29788225
• Email: maxbarahonavasquez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty
• Pain Management

Intervention

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
• 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.

Locations

Country	Name	City	State
Chile	hospital Clinico Universidad de Chile	Santiago	Region Metropolitana
Chile	Hospital San Jose	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
maximiliano barahona vasquez

Country where clinical trial is conducted

Chile, 

References & Publications (15)

Affas F, Nygårds 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: 10.3109/17453674.2011.5 — View Citation

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/bj — View Citation

Andersen LØ, 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. Review. — View Citation

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. Erratum in: Clin Orthop Relat Res. 2013 Jun — View Citation

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):1361-5. doi: 10.1016/j.arth.2015.12.028. — View Citation

García 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. — View Citation

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. — View Citation

Garrido R, Lagos N, Lattes K, Azolas CG, Bocic G, Cuneo A, Chiong H, Jensen C, Henríquez AI, Fernández 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. — View Citation

Hinzpeter J, Barrientos C, Zamorano Á, Martinez Á, Palet M, Wulf R, Barahona M, Sepúlveda 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. — View Citation

Manríquez V, Castro Caperan D, Guzmán 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tønnesen EK, Søballe 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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