<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/NCT01700517</url>
  </required_header>
  <id_info>
    <org_study_id>TKR-PAIN CONTROL</org_study_id>
    <nct_id>NCT01700517</nct_id>
  </id_info>
  <brief_title>Postoperatory Analgesia After Total Knee Arthroplasty</brief_title>
  <acronym>PAINCONTROL</acronym>
  <official_title>Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Madre Teresa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Madre Teresa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total knee arthroplasty (TKA) is a worldwide realized procedure, with 600.000 surgeries&#xD;
      performed per year in the United States, with a 673% increase estimated until 2030.&#xD;
      Functional and pain management improvement is expected in 90% of patients, with 85% of them&#xD;
      satisfied after the procedure.&#xD;
&#xD;
      Immediate postoperatory pain control is an important aspect to be considered. Patients&#xD;
      submitted to TKA endure pain with variations between 40-80 (according to analog visual scale&#xD;
      -AVS - which goes from zero to 100) during the immediate postoperatory, with slow decline in&#xD;
      the first 24 hours. Pain classified as severe occurs in 60% and moderated in 30% of patients&#xD;
      submitted to TKA during this period of time. Therefore adequate pain management allows an&#xD;
      earlier rehabilitation, with a higher satisfaction rate and decrease the hospitalization&#xD;
      period.&#xD;
&#xD;
      A multimodal control of pain can be reached by using non-steroidal anti-inflammatory, COX-2&#xD;
      anti-inflammatory inhibitors, peripheral nerve blocks and intra-articular anesthetics&#xD;
      injections and decrease use of opioids given of potential collateral effects. Peripheral&#xD;
      blockings are associated to the smallest rate of collateral effects and complications when&#xD;
      compared to the spinal anesthesia and analgesia controlled by the patients. Studies comparing&#xD;
      the effects of the femoral and sciatic-femoral blocking guided by ultrasonography for the&#xD;
      analgesia control after TKA were not found.&#xD;
&#xD;
      The objective of this article is to evaluate the effect of femoral and sciatic-femoral block&#xD;
      using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients&#xD;
      submitted to TKA, opioid consumption and complications associated to anesthesics procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria were considered: Patients with TKA indication, aged from 40 to 90 years,&#xD;
      weight between 50 and 100 kg, body mass index between 18 - 36 and patients classified&#xD;
      pre-operatory according to the American Anesthesia Association as ASA I or II.&#xD;
      Non-cooperative patients, with cognitive incapacity to answer pain VAS, neuromuscular or&#xD;
      peripheral neuropathies, chronically using opioid or who didn´t want to take part of the&#xD;
      study were taken as exclusion criteria.&#xD;
&#xD;
      The patients were separated in three groups at randomized by a computer program:&#xD;
&#xD;
      Group A - control group - spinal anesthesia, Group B - femoral nerve block + procedure&#xD;
      realized in group A and Group C - femoral and sciatic nerves block + procedure realized in&#xD;
      group A.&#xD;
&#xD;
      All the anesthetics procedures were realized by the same anesthetist. The standard anesthesia&#xD;
      for the procedure was spinal anesthesia with injection of 12 to 15 mg of 0.5% isobaric&#xD;
      bupivacaine. Patients of the control group (group A) were submitted to spinal anesthesia with&#xD;
      0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were&#xD;
      made to mask the femoral and sciatic block, respectively, with no infusion of any medication.&#xD;
      The patients of the group B received, furthermore the standard anesthesia, the block of the&#xD;
      femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and&#xD;
      neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5&#xD;
      mA energy. The technique used was femoral area puncture, at the level of the crural fold of&#xD;
      skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine. For the patients of&#xD;
      the group C, in addition to the femoral blocking, the anesthesia of the sciatic nerve at the&#xD;
      top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba&#xD;
      Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz&#xD;
      stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg&#xD;
      clonidine. As an adjuvant for analgesia, all the patients received analgesic and&#xD;
      anti-inflammatory permanently in postoperatory, with availability of opioids for rescue if&#xD;
      needed. The necessity of its use and eventual complications were registered until hospital&#xD;
      discharge.&#xD;
&#xD;
      The pain measurement was realized by the assistant author using a 10 points pain AVS (0,&#xD;
      absence of pain, and 10 the worst imaginable pain) both ignoring which group the patient was&#xD;
      part of. This measurement was realized during immediate pre-operatory, within 6, 12, 24, 48&#xD;
      hours after surgery.&#xD;
&#xD;
      Details of this study were approved by the Ethical Committee and written informed consent was&#xD;
      obtained from each participant prior to the commencement of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block</measure>
    <time_frame>48 HOURS</time_frame>
    <description>The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.&#xD;
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>PAIN</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Femoral nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sciatic nerves block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal anesthesia</intervention_name>
    <description>spinal anesthesia</description>
    <arm_group_label>Femoral nerve block</arm_group_label>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>sciatic nerves block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Femoral nerve block</intervention_name>
    <description>Femoral nerve block</description>
    <arm_group_label>Femoral nerve block</arm_group_label>
    <arm_group_label>sciatic nerves block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sciatic nerves block</intervention_name>
    <description>sciatic nerves block</description>
    <arm_group_label>sciatic nerves block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria were considered: Patients with TKA indication, aged from 40 to 90&#xD;
             years, weight between 50 and 100 kg, body mass index between 18 - 36 and patients&#xD;
             classified pre-operatory according to the American Anesthesia Association as ASA I or&#xD;
             II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-cooperative patients, with cognitive incapacity to answer pain VAS, neuromuscular&#xD;
             or peripheral neuropathies, chronically using opioid or who didn´t want to take part&#xD;
             of the study were taken as exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>LUCIO H CARVALHO, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOSPITAL MADRE TERESA - UNIVERSIDADE FEDERAL DE MINAS GERAIS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>EDUARDO F TEMPONI, MD</last_name>
    <role>Study Director</role>
    <affiliation>MADRE TERESA´S HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Madre Teresa</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>October 21, 2012</results_first_submitted>
  <results_first_submitted_qc>March 19, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 3, 2013</results_first_posted>
  <last_update_submitted>March 19, 2013</last_update_submitted>
  <last_update_submitted_qc>March 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Madre Teresa</investigator_affiliation>
    <investigator_full_name>Lucio Honorio de Carvalho Junior, PhD, PrincipalInvestigator</investigator_full_name>
    <investigator_title>PhD, COORDINATOR OF KNEE SURGERY GROUP, ASSOCIATED PROFESSOR, PRINCIPAL INVESTIGATOR</investigator_title>
  </responsible_party>
  <keyword>total knee arthroplasty, analgesia, ultrasonography</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>120 patients submitted to TKA in Madre Teresa´s Hospital between 2011 and 2012 by three authors were enrolled in this prospective, randomized, placebo controlled and double-blinded study after receiving three different types of anesthesia.</recruitment_details>
      <pre_assignment_details>Non-cooperative patients, with cognitive incapacity to understand the AVS, neuromuscular or peripheral neuropathies, chronicle use of opioids or the ones who didn´t want to take part of the study were excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Femoral Nerve Block</title>
          <description>In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.&#xD;
Spinal anesthesia : spinal anesthesia</description>
        </group>
        <group group_id="P3">
          <title>Sciatic Nerves Block</title>
          <description>In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.&#xD;
sciatic nerves block : sciatic nerves block&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Femoral Nerve Block</title>
          <description>In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.&#xD;
Spinal anesthesia : spinal anesthesia</description>
        </group>
        <group group_id="B3">
          <title>Sciatic Nerves Block</title>
          <description>In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.&#xD;
sciatic nerves block : sciatic nerves block&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="40"/>
            <count group_id="B4" value="120"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" spread="8.8"/>
                    <measurement group_id="B2" value="71.9" spread="8"/>
                    <measurement group_id="B3" value="71.8" spread="7"/>
                    <measurement group_id="B4" value="71.9" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Brazil</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block</title>
        <description>The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.&#xD;
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.</description>
        <time_frame>48 HOURS</time_frame>
        <population>This sample size was calculated for a fixed effects one-way analysis of variance design. It was assumed that the standard effect size (d) = 0.5, the level of alpha (two-tailed) = 0.05, and power = 0.8, resulting in twenty six patient. The sample was stratified, having 40 patients in each of three groups to compensate for expected dropouts</population>
        <group_list>
          <group group_id="O1">
            <title>Femoral Nerve Block</title>
            <description>In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block&#xD;
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.</description>
          </group>
          <group group_id="O3">
            <title>Sciatic Nerves Block</title>
            <description>In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.&#xD;
sciatic nerves block : sciatic nerves block&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block&#xD;
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block</title>
          <description>The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.&#xD;
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.</description>
          <population>This sample size was calculated for a fixed effects one-way analysis of variance design. It was assumed that the standard effect size (d) = 0.5, the level of alpha (two-tailed) = 0.05, and power = 0.8, resulting in twenty six patient. The sample was stratified, having 40 patients in each of three groups to compensate for expected dropouts</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="2.8" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O3" value="1.5" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Femoral Nerve Block</title>
          <description>In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.&#xD;
Spinal anesthesia : spinal anesthesia</description>
        </group>
        <group group_id="E3">
          <title>Sciatic Nerves Block</title>
          <description>In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.&#xD;
sciatic nerves block : sciatic nerves block&#xD;
Spinal anesthesia : spinal anesthesia&#xD;
Femoral nerve block : Femoral nerve block</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The relative small sample size is one of them. Differences between groups are expected to grow as sample size increases. Despite an improvement in pain control with femoral and sciatic femoral blocks, the morphine consumption was not reduced.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr Lucio Honorio de Carvalho Júnior</name_or_title>
      <organization>Madre Teresa´s Hospital</organization>
      <phone>+55 31 33398000</phone>
      <email>luciohcj@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01700517
org study id: TKR-PAIN CONTROL
nct id: NCT01700517
lead sponsor: 
has dmc: Yes
Total knee arthroplasty (TKA) is a worldwide realized procedure, with 600.000 surgeries
      performed per year in the United States, with a 673% increase estimated until 2030.
      Functional and pain management improvement is expected in 90% of patients, with 85% of them
      satisfied after the procedure.

      Immediate postoperatory pain control is an important aspect to be considered. Patients
      submitted to TKA endure pain with variations between 40-80 (according to analog visual scale
      -AVS - which goes from zero to 100) during the immediate postoperatory, with slow decline in
      the first 24 hours. Pain classified as severe occurs in 60% and moderated in 30% of patients
      submitted to TKA during this period of time. Therefore adequate pain management allows an
      earlier rehabilitation, with a higher satisfaction rate and decrease the hospitalization
      period.

      A multimodal control of pain can be reached by using non-steroidal anti-inflammatory, COX-2
      anti-inflammatory inhibitors, peripheral nerve blocks and intra-articular anesthetics
      injections and decrease use of opioids given of potential collateral effects. Peripheral
      blockings are associated to the smallest rate of collateral effects and complications when
      compared to the spinal anesthesia and analgesia controlled by the patients. Studies comparing
      the effects of the femoral and sciatic-femoral blocking guided by ultrasonography for the
      analgesia control after TKA were not found.

      The objective of this article is to evaluate the effect of femoral and sciatic-femoral block
      using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients
      submitted to TKA, opioid consumption and complications associated to anesthesics procedures.
Inclusion criteria were considered: Patients with TKA indication, aged from 40 to 90 years,
      weight between 50 and 100 kg, body mass index between 18 - 36 and patients classified
      pre-operatory according to the American Anesthesia Association as ASA I or II.
      Non-cooperative patients, with cognitive incapacity to answer pain VAS, neuromuscular or
      peripheral neuropathies, chronically using opioid or who didn´t want to take part of the
      study were taken as exclusion criteria.

      The patients were separated in three groups at randomized by a computer program:

      Group A - control group - spinal anesthesia, Group B - femoral nerve block + procedure
      realized in group A and Group C - femoral and sciatic nerves block + procedure realized in
      group A.

      All the anesthetics procedures were realized by the same anesthetist. The standard anesthesia
      for the procedure was spinal anesthesia with injection of 12 to 15 mg of 0.5% isobaric
      bupivacaine. Patients of the control group (group A) were submitted to spinal anesthesia with
      0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were
      made to mask the femoral and sciatic block, respectively, with no infusion of any medication.
      The patients of the group B received, furthermore the standard anesthesia, the block of the
      femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and
      neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5
      mA energy. The technique used was femoral area puncture, at the level of the crural fold of
      skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine. For the patients of
      the group C, in addition to the femoral blocking, the anesthesia of the sciatic nerve at the
      top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba
      Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz
      stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg
      clonidine. As an adjuvant for analgesia, all the patients received analgesic and
      anti-inflammatory permanently in postoperatory, with availability of opioids for rescue if
      needed. The necessity of its use and eventual complications were registered until hospital
      discharge.

      The pain measurement was realized by the assistant author using a 10 points pain AVS (0,
      absence of pain, and 10 the worst imaginable pain) both ignoring which group the patient was
      part of. This measurement was realized during immediate pre-operatory, within 6, 12, 24, 48
      hours after surgery.

      Details of this study were approved by the Ethical Committee and written informed consent was
      obtained from each participant prior to the commencement of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Postoperatory Analgesia After Total Knee Arthroplasty Comparing Femoral and Sciatic-femoral Block
time frame: 48 HOURS
description: The objective of this article is to evaluate the effect of femoral and sciatic-femoral block using ultrasonography by the analog visual scale (AVS) of pain in postoperatory of patients submitted to TKA, opioid consumption and complications associated to anesthesics procedures.
To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed.
arm group label: control group
arm group type: Sham Comparator
description: Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.
arm group label: Femoral nerve block
arm group type: Experimental
description: In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.
arm group label: sciatic nerves block
arm group type: Experimental
description: In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.
intervention type: Other
intervention name: Spinal anesthesia
description: spinal anesthesia
arm group label: Femoral nerve block
arm group label: control group
arm group label: sciatic nerves block
intervention type: Other
intervention name: Femoral nerve block
description: Femoral nerve block
arm group label: Femoral nerve block
arm group label: sciatic nerves block
intervention type: Other
intervention name: sciatic nerves block
description: sciatic nerves block
arm group label: sciatic nerves block
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: LUCIO H CARVALHO, PhD
role: Principal Investigator
affiliation: HOSPITAL MADRE TERESA - UNIVERSIDADE FEDERAL DE MINAS GERAIS
last name: EDUARDO F TEMPONI, MD
role: Study Director
affiliation: MADRE TERESA´S HOSPITAL
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Hospital Madre Teresa
investigator full name: Lucio Honorio de Carvalho Junior, PhD, PrincipalInvestigator
investigator title: PhD, COORDINATOR OF KNEE SURGERY GROUP, ASSOCIATED PROFESSOR, PRINCIPAL INVESTIGATOR
mesh term: Anesthetics
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The relative small sample size is one of them. Differences between groups are expected to grow as sample size increases. Despite an improvement in pain control with femoral and sciatic femoral blocks, the morphine consumption was not reduced.
point of contact: 