<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03025594</url>
  </required_header>
  <id_info>
    <org_study_id>AIC 769/15</org_study_id>
    <nct_id>NCT03025594</nct_id>
  </id_info>
  <brief_title>Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty</brief_title>
  <acronym>Toxin</acronym>
  <official_title>Gonyautoxins Local Periarticular Injection for Pain Management After Total Knee Arthroplasty: A Double Blind Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>maximiliano barahona vasquez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to demostrate the eficcacy in pain control management after total&#xD;
      knee arthroplasty of Gonyautoxin. Local administration during surgery of Gonyautoxin before&#xD;
      wound closure can achieved better pain control and lower morphin use during hospital stay&#xD;
      compared to local administration of chirocaine, ketorolac and epinephrine&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>morphine consume</measure>
    <time_frame>60hrs post surgery</time_frame>
    <description>total consumption of morphine at 60 hours after total knee arthroplaty</description>
  </primary_outcome>
  <primary_outcome>
    <measure>range of motion 1</measure>
    <time_frame>12hours post surgery</time_frame>
    <description>Range of motion of the knee that underwent arthroplasty after 12 hours of surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>early morphine consume</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>total morphine consumption during first 24 hours after total knee arthroplaty</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion 2</measure>
    <time_frame>36 hours after surgery</time_frame>
    <description>Range of motion of the knee that underwent arthroplasty at 36 hours after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>range of motion 3</measure>
    <time_frame>60 hours after surgery</time_frame>
    <description>Range of motion of the knee that underwent arthroplasty at 60 hours after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time of up and go test 1</measure>
    <time_frame>1 day after surgery</time_frame>
    <description>Difference in speed when performing the &quot;up and go&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time of up and go test 2</measure>
    <time_frame>2 days after surgery</time_frame>
    <description>Difference in speed when performing the &quot;up and go&quot; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain visual analague scale 1</measure>
    <time_frame>12 hours post surgery</time_frame>
    <description>pain visual analague scale (scale 0-10) applied at rest and post physioterapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain visual analague scale 2</measure>
    <time_frame>36 hours post surgery</time_frame>
    <description>pain visual analague scale (scale 0-10) applied at rest and post physioterapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain visual analague scale 3</measure>
    <time_frame>60 hours post surgery</time_frame>
    <description>pain visual analague scale (scale 0-10) applied at rest and post physioterapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Knee Arthroplasty</condition>
  <condition>Pain Management</condition>
  <arm_group>
    <arm_group_label>Gonyautoxin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gonyautoxin 40mcg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mix of chirocaine 0,2%, ketorolac and epinephrine..</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gonyautoxins</intervention_name>
    <description>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</description>
    <arm_group_label>Gonyautoxin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chirocaine ketorolac epinephrine</intervention_name>
    <description>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.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who required total knee arthroplasty due to knee osteoarthritis ( Kellgren&#xD;
             and Lawrence score of 2 or more), with no response to conservative management.&#xD;
&#xD;
          -  Without known allergies to the drugs used in the study&#xD;
&#xD;
          -  Anesthetic risk: ASA Score 1,2,3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Obesity, defined as body Mass index over 35&#xD;
&#xD;
          -  Previous Knee surgery&#xD;
&#xD;
          -  Mellitus diabetes&#xD;
&#xD;
          -  Organic brain damage&#xD;
&#xD;
          -  Rheumatic Arthritis&#xD;
&#xD;
          -  Coagulation deficit&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Chronic consumption of opiods&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hinzpeter R Jaime, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>orthopaedic surgeon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barahona A Maximiliano, MD MBiostat</last_name>
    <phone>56 2 29788225</phone>
    <email>maxbarahonavasquez@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Barrientos N Cristian, MD</last_name>
    <phone>56 2 29788226</phone>
    <email>cristianbarrien@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital San Jose</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>8380419</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Martinez Alvaro, MD</last_name>
      <phone>962290744</phone>
      <email>martinezh.alvaro@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>barrientos n cristian</last_name>
      <phone>998749180</phone>
      <email>cristianbarrien@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>hospital Clinico Universidad de Chile</name>
      <address>
        <city>Santiago</city>
        <state>Region Metropolitana</state>
        <zip>8380456</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>barahona a maximiliano, MD MBiostat</last_name>
      <phone>29788225</phone>
      <email>maxbarahonavasquez@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>barrientos n cristian, MD</last_name>
      <phone>29788226</phone>
      <email>cristianbarrien@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>25571865</PMID>
  </reference>
  <reference>
    <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. Epub 2009 Jul 28.</citation>
    <PMID>19636660</PMID>
  </reference>
  <reference>
    <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. doi: 10.1097/00000542-200702000-00023.</citation>
    <PMID>17264729</PMID>
  </reference>
  <reference>
    <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. doi: 10.1007/s10350-004-0893-4.</citation>
    <PMID>15812585</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15515965</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15019474</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>27317871</PMID>
  </results_reference>
  <results_reference>
    <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):1361-1365. doi: 10.1016/j.arth.2015.12.028. Epub 2015 Dec 20.</citation>
    <PMID>26810604</PMID>
  </results_reference>
  <results_reference>
    <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. Epub 2013 Mar 21. Erratum In: Clin Orthop Relat Res. 2013 Jun;471(6):2042.</citation>
    <PMID>23516031</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>24939863</PMID>
  </results_reference>
  <results_reference>
    <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/bja/aew099.</citation>
    <PMID>27106963</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>17464603</PMID>
  </results_reference>
  <results_reference>
    <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. Epub 2014 Jan 5.</citation>
    <PMID>24719708</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>21561303</PMID>
  </results_reference>
  <results_reference>
    <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. doi: 10.1177/230949901202000105.</citation>
    <PMID>22535806</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>maximiliano barahona vasquez</investigator_full_name>
    <investigator_title>MD, MBiostat</investigator_title>
  </responsible_party>
  <keyword>Paralytic sellfish toxins</keyword>
  <keyword>Gonyautoxin</keyword>
  <keyword>Post surgery pain management</keyword>
  <keyword>total knee arthroplasty</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>April 27, 2021</submitted>
    <returned>May 19, 2021</returned>
    <submitted>May 21, 2021</submitted>
    <returned>June 15, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03025594
org study id: AIC 769/15
nct id: NCT03025594
lead sponsor: 
has dmc: Yes
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: morphine consume
time frame: 60hrs post surgery
description: total consumption of morphine at 60 hours after total knee arthroplaty
measure: range of motion 1
time frame: 12hours post surgery
description: Range of motion of the knee that underwent arthroplasty after 12 hours of surgery
measure: early morphine consume
time frame: 1 day after surgery
description: total morphine consumption during first 24 hours after total knee arthroplaty
measure: range of motion 2
time frame: 36 hours after surgery
description: Range of motion of the knee that underwent arthroplasty at 36 hours after surgery
measure: range of motion 3
time frame: 60 hours after surgery
description: Range of motion of the knee that underwent arthroplasty at 60 hours after surgery
measure: time of up and go test 1
time frame: 1 day after surgery
description: 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.
measure: time of up and go test 2
time frame: 2 days after surgery
description: 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.
measure: pain visual analague scale 1
time frame: 12 hours post surgery
description: pain visual analague scale (scale 0-10) applied at rest and post physioterapy
measure: pain visual analague scale 2
time frame: 36 hours post surgery
description: pain visual analague scale (scale 0-10) applied at rest and post physioterapy
measure: pain visual analague scale 3
time frame: 60 hours post surgery
description: pain visual analague scale (scale 0-10) applied at rest and post physioterapy
arm group label: Gonyautoxin
arm group type: Experimental
description: Gonyautoxin 40mcg
arm group label: Control
arm group type: Active Comparator
description: Mix of chirocaine 0,2%, ketorolac and epinephrine..
intervention type: Drug
intervention name: Gonyautoxins
description: 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
arm group label: Gonyautoxin
intervention type: Drug
intervention name: Chirocaine ketorolac epinephrine
description: 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.
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: 80 Years
healthy volunteers: No
last name: Hinzpeter R Jaime, MD
role: Principal Investigator
affiliation: orthopaedic surgeon
last name: Barahona A Maximiliano, MD MBiostat
phone: 56 2 29788225
email: maxbarahonavasquez@gmail.com
last name: Barrientos N Cristian, MD
phone: 56 2 29788226
email: cristianbarrien@gmail.com
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Chile
citation: 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
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. Epub 2009 Jul 28.
PMID: 19636660
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. doi: 10.1097/00000542-200702000-00023.
PMID: 17264729
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. doi: 10.1007/s10350-004-0893-4.
PMID: 15812585
citation: 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
citation: 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
citation: 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
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):1361-1365. doi: 10.1016/j.arth.2015.12.028. Epub 2015 Dec 20.
PMID: 26810604
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. Epub 2013 Mar 21. Erratum In: Clin Orthop Relat Res. 2013 Jun;471(6):2042.
PMID: 23516031
citation: 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
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/bja/aew099.
PMID: 27106963
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responsible party type: Sponsor-Investigator
investigator affiliation: University of Chile
investigator full name: maximiliano barahona vasquez
investigator title: MD, MBiostat
mesh term: Ketorolac
mesh term: Epinephrine
mesh term: Levobupivacaine
sharing ipd: Yes
ipd 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.
submitted: April 27, 2021
returned: May 19, 2021
submitted: May 21, 2021
returned: June 15, 2021