<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/NCT02239497</url>
  </required_header>
  <id_info>
    <org_study_id>Femoral Block</org_study_id>
    <nct_id>NCT02239497</nct_id>
  </id_info>
  <brief_title>Femoral Preincisional Block in Acute Postoperative Pain Management of Surgery Orthopaedic Lower Limb</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Central Dr. Luis Ortega</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Central Dr. Luis Ortega</source>
  <brief_summary>
    <textblock>
      Proper management of acute postoperative pain (DAPO) is essential for the recovery of&#xD;
      orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its&#xD;
      effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the&#xD;
      effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under&#xD;
      general anesthesia. METHODS: A comparative study was conducted, randomized, two groups,&#xD;
      surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP&#xD;
      and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1:&#xD;
      200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with&#xD;
      ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia.&#xD;
      Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperatory EVA values and need for rescue analgesia with IV morphine</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>femoral block by US and NE and intravenous analgesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>preincisional femoral block by ultrasound and neurostimulation, with 20 ml bupivacaine 0,5% and epinephrine. ketoprofen, dipyrone and dexamethasone IV. Morphine IV to rescue analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous analgesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous analgesia with ketoprofen, dipyrone and morphine. IV morphine to rescue analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral block by ultrasound and neurostimulation</intervention_name>
    <arm_group_label>femoral block by US and NE and intravenous analgesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous analgesia</intervention_name>
    <description>Intravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia</description>
    <arm_group_label>Intravenous analgesia</arm_group_label>
    <arm_group_label>femoral block by US and NE and intravenous analgesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I and II patients, both sexes, plan for elective orthopaedic surgery of the lower&#xD;
             limbs (femur and knee) under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any anesthetic or surgical complication&#xD;
&#xD;
          -  Patients with neuromuscular diseases&#xD;
&#xD;
          -  Allergy to any of the drugs used in the study&#xD;
&#xD;
          -  Inability to understand and use a pain scale&#xD;
&#xD;
          -  Also those patients in whom it was not possible to locate anatomical landmarks and /&#xD;
             or failed femoral block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beatriz S Arismendi Gomez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital &quot;Dr Luis Ortega&quot;</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Servicio de Anestesiologia Hospital &quot;Dr. Luis Ortega&quot;</name>
      <address>
        <city>Porlamar</city>
        <state>Estado Nueva Esparta</state>
        <zip>6301</zip>
        <country>Venezuela</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Venezuela</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Central Dr. Luis Ortega</investigator_affiliation>
    <investigator_full_name>Beatriz Arismendi Gómez</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>postoperatory pain</keyword>
  <keyword>orthopaedic surgery</keyword>
  <keyword>femoral block</keyword>
  <!-- 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/NCT02239497
org study id: Femoral Block
nct id: NCT02239497
lead sponsor: 
Proper management of acute postoperative pain (DAPO) is essential for the recovery of
      orthopedic surgeries. The blockade of the femoral nerve preincisional (BFP) is simple and its
      effectiveness increases guided by ultrasound and neurostimulation. OBJECTIVE: To evaluate the
      effectiveness of BFP in patients undergoing orthopedic surgery of the lower limbs under
      general anesthesia. METHODS: A comparative study was conducted, randomized, two groups,
      surgeries of the hip, femur and knee, ASA I-II, aged 18 years. Group B (n = 15) received BFP
      and ultrasound-guided nerve stimulation with 20 ml of bupivacaine 0.5% plus epinephrine 1:
      200,000. Group S (n = 15) without blocking. Both groups received intravenous analgesia with
      ketoprofen 100 mg regimen and dipyrone 1g c / 8 hs and balanced general anesthesia.
      Postoperative morphine 0.03 mgr / kgr / weight was administered if EVA ≥4
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperatory EVA values and need for rescue analgesia with IV morphine
time frame: 24 hours
arm group label: femoral block by US and NE and intravenous analgesia
arm group type: Experimental
description: preincisional femoral block by ultrasound and neurostimulation, with 20 ml bupivacaine 0,5% and epinephrine. ketoprofen, dipyrone and dexamethasone IV. Morphine IV to rescue analgesia
arm group label: Intravenous analgesia
arm group type: Experimental
description: Intravenous analgesia with ketoprofen, dipyrone and morphine. IV morphine to rescue analgesia
intervention type: Procedure
intervention name: Femoral block by ultrasound and neurostimulation
arm group label: femoral block by US and NE and intravenous analgesia
intervention type: Drug
intervention name: Intravenous analgesia
description: Intravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia
arm group label: Intravenous analgesia
arm group label: femoral block by US and NE and intravenous analgesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Beatriz S Arismendi Gomez, MD
role: Principal Investigator
affiliation: Hospital "Dr Luis Ortega"
facility: 
country: Venezuela
responsible party type: Principal Investigator
investigator affiliation: Hospital Central Dr. Luis Ortega
investigator full name: Beatriz Arismendi Gómez
investigator title: Anesthesiologist