<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/NCT03815565</url>
  </required_header>
  <id_info>
    <org_study_id>65821217.5.0000.8066</org_study_id>
    <nct_id>NCT03815565</nct_id>
  </id_info>
  <brief_title>Continuous Femoral Block With Levobupivacaine 0.125% or Ropivacaine 0.2% in Elderly Patients With Femoral Fractures</brief_title>
  <official_title>Comparison Between Continuous Femoral Block With Levobupivacaine 0.125% and Ropivacaine 0.2% for Preoperative Analgesia, in Patients Over 70 Years Old, With Proximal Femoral Fractures: a Randomized, Double-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Municipal Miguel Couto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Municipal Miguel Couto</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the continuous femoral block between levobupivacaine 0.125% and&#xD;
      ropivacaine 0.2% in patients with proximal femoral fracture.These patients will be divided&#xD;
      into 2 groups of 35 patients, one L group (levobupivacaine 0.125%) and one R group&#xD;
      (ropivacaine 0.2%) distributed randomly, receiving continuous infusion through patient&#xD;
      controlled analgesia (PCA) pump with the following parameters: infusion 5 ml / h, bolus 5 ml,&#xD;
      lockout 30 min.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is associated with neurohormonal stress, myocardial ischemia and delayed mobilization,&#xD;
      thus being able to increase the hospitalization time and associated with increased&#xD;
      postoperative mortality. Regional anesthesia through simple or continuous femoral nerve block&#xD;
      are options for analgesia in patients with femoral fracture, as well as analgesia by venous&#xD;
      opioids. A potential benefit of regional anesthesia is precisely to avoid the use of opioids&#xD;
      and other general anesthetics, which in turn are also closely related to postoperative&#xD;
      delirium. Continuous femoral block, since the preoperative period, is associated with the&#xD;
      reduction of acute pain and opioid consumption, in patients with femoral neck fractures.&#xD;
      There are few studies available in the literature comparing analgesic equipotency between&#xD;
      levobupivacaine and ropivacaine in peripheral nerve blocks. In none of them, the peripheral&#xD;
      analgesia in the femoral nerve, for proximal femoral fracture was compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">January 8, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 8, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Only the pharmacist chief knows which participant belongs to each arm</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>intensity of individual pain episodes</measure>
    <time_frame>6 hours after hospital admission</time_frame>
    <description>Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of PCA firing</measure>
    <time_frame>72 hours</time_frame>
    <description>in each patient at time of evaluation of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of satisfaction with analgesic therapy</measure>
    <time_frame>up to 72 hours - at the moment of surgery; or at the end of 72 hours</time_frame>
    <description>using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep</measure>
    <time_frame>up to 72 hours</time_frame>
    <description>very good, good, bad and very bad</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the cost of analgesic therapy</measure>
    <time_frame>up to 72 hours</time_frame>
    <description>including catheters, PCA and medication in each patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>up to 72 hours</time_frame>
    <description>paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Femur Fracture</condition>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>levobupivacaine 0.125%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>continuous femoral block with levobupivacaine 0.125%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ropivacaine 0.2%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>continuous femoral block with ropivacaine 0.2%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>continuous femoral block</intervention_name>
    <description>infusion of anesthetic by PCA pump</description>
    <arm_group_label>levobupivacaine 0.125%</arm_group_label>
    <arm_group_label>ropivacaine 0.2%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  70 years old or more&#xD;
&#xD;
          -  patients with femur fracture&#xD;
&#xD;
          -  physical status risk American Society of Anesthesiologists (ASA) P1 - P3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physical status ASA P4&#xD;
&#xD;
          -  patients with BMI &gt; 35&#xD;
&#xD;
          -  systemic infection&#xD;
&#xD;
          -  Injury or infection at the site of installation of the femoral perineural catheter&#xD;
&#xD;
          -  Catheter displacement of the perineural site&#xD;
&#xD;
          -  Montreal Cognitive Assessment (MoCA) &lt; 26&#xD;
&#xD;
          -  Patients operated before 24 hours of hospital admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rafael Linhares</last_name>
    <phone>+55 21 981436088</phone>
    <email>rafaellinhares@me.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ismar Cavalcanti</last_name>
    <phone>+55 21 999822993</phone>
    <email>ismarcavalcanti@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rafael M Linhares</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22776050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafael Linhares</last_name>
      <phone>+55 21 981436088</phone>
      <email>rafaellinhares@me.com</email>
    </contact>
    <contact_backup>
      <last_name>Ismar Cavalcanti</last_name>
      <phone>+55 21 999822993</phone>
      <email>ismarcavalcanti@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20.</citation>
    <PMID>27871587</PMID>
  </reference>
  <results_reference>
    <citation>Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2.</citation>
    <PMID>26330019</PMID>
  </results_reference>
  <results_reference>
    <citation>Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.</citation>
    <PMID>12791436</PMID>
  </results_reference>
  <results_reference>
    <citation>Szucs S, Iohom G, O'Donnell B, Sajgalik P, Ahmad I, Salah N, Shorten G. Analgesic efficacy of continuous femoral nerve block commenced prior to operative fixation of fractured neck of femur. Perioper Med (Lond). 2012 Jun 27;1:4. doi: 10.1186/2047-0525-1-4. eCollection 2012.</citation>
    <PMID>24764520</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Municipal Miguel Couto</investigator_affiliation>
    <investigator_full_name>Rafael Mercante Linhares</investigator_full_name>
    <investigator_title>Head of Anesthesiology and Pain Medicine Department</investigator_title>
  </responsible_party>
  <keyword>analgesia</keyword>
  <keyword>continuous</keyword>
  <keyword>femoral block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>after the finish of the study</ipd_description>
  </patient_data>
  <!-- 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/NCT03815565
org study id: 65821217.5.0000.8066
nct id: NCT03815565
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the continuous femoral block between levobupivacaine 0.125% and
      ropivacaine 0.2% in patients with proximal femoral fracture.These patients will be divided
      into 2 groups of 35 patients, one L group (levobupivacaine 0.125%) and one R group
      (ropivacaine 0.2%) distributed randomly, receiving continuous infusion through patient
      controlled analgesia (PCA) pump with the following parameters: infusion 5 ml / h, bolus 5 ml,
      lockout 30 min.
Pain is associated with neurohormonal stress, myocardial ischemia and delayed mobilization,
      thus being able to increase the hospitalization time and associated with increased
      postoperative mortality. Regional anesthesia through simple or continuous femoral nerve block
      are options for analgesia in patients with femoral fracture, as well as analgesia by venous
      opioids. A potential benefit of regional anesthesia is precisely to avoid the use of opioids
      and other general anesthetics, which in turn are also closely related to postoperative
      delirium. Continuous femoral block, since the preoperative period, is associated with the
      reduction of acute pain and opioid consumption, in patients with femoral neck fractures.
      There are few studies available in the literature comparing analgesic equipotency between
      levobupivacaine and ropivacaine in peripheral nerve blocks. In none of them, the peripheral
      analgesia in the femoral nerve, for proximal femoral fracture was compared.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Only the pharmacist chief knows which participant belongs to each arm
measure: intensity of individual pain episodes
time frame: 6 hours after hospital admission
description: Self report pain intensity in the preoperative period. Scored 0-10 (0 = no pain; 10 = pain as bad as can be)
measure: Number of PCA firing
time frame: 72 hours
description: in each patient at time of evaluation of pain
measure: Degree of satisfaction with analgesic therapy
time frame: up to 72 hours - at the moment of surgery; or at the end of 72 hours
description: using the 5-point rating scale (very dissatisfied, dissatisfied, neutral, satisfied or very pleased)
measure: Quality of sleep
time frame: up to 72 hours
description: very good, good, bad and very bad
measure: the cost of analgesic therapy
time frame: up to 72 hours
description: including catheters, PCA and medication in each patient
measure: adverse event
time frame: up to 72 hours
description: paresthesia, nausea, vomiting, ringing in the ear, metallic taste, convulsion or cardiac arrest
arm group label: levobupivacaine 0.125%
arm group type: Experimental
description: continuous femoral block with levobupivacaine 0.125%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes
arm group label: ropivacaine 0.2%
arm group type: Active Comparator
description: continuous femoral block with ropivacaine 0.2%. Use of PCA pump with the following parameters: 5 ml/h; bolus 5 ml; lockout 30 minutes
intervention type: Procedure
intervention name: continuous femoral block
description: infusion of anesthetic by PCA pump
arm group label: levobupivacaine 0.125%
arm group label: ropivacaine 0.2%
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rafael Linhares
phone: +55 21 981436088
email: rafaellinhares@me.com
last name: Ismar Cavalcanti
phone: +55 21 999822993
email: ismarcavalcanti@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
citation: Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20.
PMID: 27871587
citation: Ritcey B, Pageau P, Woo MY, Perry JJ. Regional Nerve Blocks For Hip and Femoral Neck Fractures in the Emergency Department: A Systematic Review. CJEM. 2016 Jan;18(1):37-47. doi: 10.1017/cem.2015.75. Epub 2015 Sep 2.
PMID: 26330019
citation: Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.
PMID: 12791436
citation: Szucs S, Iohom G, O'Donnell B, Sajgalik P, Ahmad I, Salah N, Shorten G. Analgesic efficacy of continuous femoral nerve block commenced prior to operative fixation of fractured neck of femur. Perioper Med (Lond). 2012 Jun 27;1:4. doi: 10.1186/2047-0525-1-4. eCollection 2012.
PMID: 24764520
responsible party type: Principal Investigator
investigator affiliation: Hospital Municipal Miguel Couto
investigator full name: Rafael Mercante Linhares
investigator title: Head of Anesthesiology and Pain Medicine Department
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Femoral Fractures
sharing ipd: Undecided
ipd description: after the finish of the study