<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/NCT02201784</url>
  </required_header>
  <id_info>
    <org_study_id>jnmch2012</org_study_id>
    <nct_id>NCT02201784</nct_id>
  </id_info>
  <brief_title>Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery</brief_title>
  <official_title>A Comparative Study Between Levobupivacaine 0.5% and Ropivacaine 0.75% in Patients Undergoing Spinal Anaesthesia for Lower Limb Orthopaedic Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aligarh Muslim University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aligarh Muslim University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effects of two intrathecally administered&#xD;
      drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer&#xD;
      drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are&#xD;
      preferred now a days.So, we conducted this prospective, randomized double blind study with an&#xD;
      aim of comparing the efficacy and characteristics of these drugs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Analgesia</measure>
    <time_frame>8 hours</time_frame>
    <description>Defined as time for first analgesic request by the patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Onset of Sensory Block at T10</measure>
    <time_frame>30 minutes</time_frame>
    <description>level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Maximum Level of Sensory Blockade</measure>
    <time_frame>8 hours</time_frame>
    <description>level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Maximum Cephalic Spread of Sensory Block</measure>
    <time_frame>8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Onset of Motor Block to Bromage3</measure>
    <time_frame>8 hours</time_frame>
    <description>Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Motor Block</measure>
    <time_frame>8 hours</time_frame>
    <description>Time when the Bromage score will be back to zero</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pulse Rate, Mean Arterial Pressure, SpO2</measure>
    <time_frame>8 hours</time_frame>
    <description>Intragroup and intergroup variation compared</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lower Limb Surgery</condition>
  <arm_group>
    <arm_group_label>Levobupivacaine 0.5%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacaine 0.75%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine</intervention_name>
    <description>Comparison of Equipotent doses</description>
    <arm_group_label>Levobupivacaine 0.5%</arm_group_label>
    <other_name>Chirocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Comparison of equipotent doses</description>
    <arm_group_label>Ropivacaine 0.75%</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. American Society of Anesthesiologists (ASA) class I &amp; II patients of either sex&#xD;
&#xD;
          2. Age between 18-60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient's refusal.&#xD;
&#xD;
          2. Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.&#xD;
&#xD;
          3. Patients having h/o diabetes, neurological and musculoskeletal diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manazir Athar, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jawaharlal Nehru Medical College, AMU,Aligarh, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Syed Moied Ahmed, PhD, M.D</last_name>
    <role>Study Director</role>
    <affiliation>Jawaharlal Nehru Medical College, AMU, Aligarh, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Masood H Siddiqi, M.S</last_name>
    <role>Study Director</role>
    <affiliation>Jawaharlal Nehru Medical College, AMU, Aligarh, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jawaharlal Nehru medical college, AMU</name>
      <address>
        <city>Aligarh</city>
        <state>Uttar Pradesh</state>
        <zip>202002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>January 14, 2015</results_first_submitted>
  <results_first_submitted_qc>January 14, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 21, 2015</results_first_posted>
  <last_update_submitted>January 14, 2015</last_update_submitted>
  <last_update_submitted_qc>January 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aligarh Muslim University</investigator_affiliation>
    <investigator_full_name>MANAZIR ATHAR</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Subarachnoid block</keyword>
  <keyword>intrathecal</keyword>
  <keyword>spinal anesthesia</keyword>
  <keyword>isobaric</keyword>
  <keyword>levobupivacaine</keyword>
  <keyword>ropivacaine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>jawaharlal nehru medical college and hospital</recruitment_details>
      <pre_assignment_details>Patients who met any of the exclusion criteria or those who did not gave consent were excluded.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Levobupivacaine 0.5%</title>
          <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
        </group>
        <group group_id="P2">
          <title>Ropivacaine 0.75%</title>
          <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Failure to achieve adequate block</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Levobupivacaine 0.5%</title>
          <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
        </group>
        <group group_id="B2">
          <title>Ropivacaine 0.75%</title>
          <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</description>
        </group>
        <group group_id="B3">
          <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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="38" spread="17"/>
                    <measurement group_id="B2" value="35" spread="16"/>
                    <measurement group_id="B3" value="37" spread="16"/>
                  </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="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="47"/>
                  </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>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53.83" spread="9.44"/>
                    <measurement group_id="B2" value="57.17" spread="6.65"/>
                    <measurement group_id="B3" value="55.5" spread="8.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Analgesia</title>
        <description>Defined as time for first analgesic request by the patient</description>
        <time_frame>8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Levobupivacaine 0.5%</title>
            <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine 0.75%</title>
            <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Analgesia</title>
          <description>Defined as time for first analgesic request by the patient</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="309.83" spread="36.45"/>
                    <measurement group_id="O2" value="249.50" spread="22.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Onset of Sensory Block at T10</title>
        <description>level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.</description>
        <time_frame>30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Levobupivacaine 0.5%</title>
            <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine 0.75%</title>
            <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</description>
          </group>
        </group_list>
        <measure>
          <title>Onset of Sensory Block at T10</title>
          <description>level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.50" spread="4.94"/>
                    <measurement group_id="O2" value="7.33" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Maximum Level of Sensory Blockade</title>
        <description>level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.</description>
        <time_frame>8 hours</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Maximum Cephalic Spread of Sensory Block</title>
        <time_frame>8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Levobupivacaine 0.5%</title>
            <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine 0.75%</title>
            <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Maximum Cephalic Spread of Sensory Block</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.33" spread="5.31"/>
                    <measurement group_id="O2" value="13.17" spread="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Onset of Motor Block to Bromage3</title>
        <description>Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).</description>
        <time_frame>8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Levobupivacaine 0.5%</title>
            <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine 0.75%</title>
            <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</description>
          </group>
        </group_list>
        <measure>
          <title>Onset of Motor Block to Bromage3</title>
          <description>Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.17" spread="4.09"/>
                    <measurement group_id="O2" value="7.83" spread="2.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Motor Block</title>
        <description>Time when the Bromage score will be back to zero</description>
        <time_frame>8 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Levobupivacaine 0.5%</title>
            <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine 0.75%</title>
            <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Motor Block</title>
          <description>Time when the Bromage score will be back to zero</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="290.50" spread="34.67"/>
                    <measurement group_id="O2" value="222.50" spread="23.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pulse Rate, Mean Arterial Pressure, SpO2</title>
        <description>Intragroup and intergroup variation compared</description>
        <time_frame>8 hours</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Levobupivacaine 0.5%</title>
          <description>intrathecal administration of 15 mg of Levobupivacaine 0.5%&#xD;
Levobupivacaine: Comparison of Equipotent doses</description>
        </group>
        <group group_id="E2">
          <title>Ropivacaine 0.75%</title>
          <description>intrathecal administration of 22.5 mg of Ropivacaine 0.75%&#xD;
Ropivacaine: Comparison of equipotent doses</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Heart rate was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room.Bradycardia was defined as HR&lt;50 beat/min</description>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Arterial blood pressure was recorded before induction, every 3 min till 15 minutes, then, every 15 min until discharge from the recovery room. Hypotension was defined as systolic BP &lt; 90 mm Hg</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Shivering</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
              </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>Exact baricity was not known as Specific gravity was not measured; Quality of anaesthesia was not assessed</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Manazir Athar</name_or_title>
      <organization>Jawaharlal Nehru Medical College, AMU, Aligarh, India</organization>
      <phone>+918868056469</phone>
      <email>drmanazirathar@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/NCT02201784
org study id: jnmch2012
nct id: NCT02201784
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the effects of two intrathecally administered
      drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia
Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer
      drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are
      preferred now a days.So, we conducted this prospective, randomized double blind study with an
      aim of comparing the efficacy and characteristics of these drugs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Duration of Analgesia
time frame: 8 hours
description: Defined as time for first analgesic request by the patient
measure: Onset of Sensory Block at T10
time frame: 30 minutes
description: level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.
measure: Median Maximum Level of Sensory Blockade
time frame: 8 hours
description: level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.
measure: Time to Maximum Cephalic Spread of Sensory Block
time frame: 8 hours
measure: Onset of Motor Block to Bromage3
time frame: 8 hours
description: Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).
measure: Duration of Motor Block
time frame: 8 hours
description: Time when the Bromage score will be back to zero
measure: Pulse Rate, Mean Arterial Pressure, SpO2
time frame: 8 hours
description: Intragroup and intergroup variation compared
arm group label: Levobupivacaine 0.5%
arm group type: Active Comparator
description: intrathecal administration of 15 mg of Levobupivacaine 0.5%
arm group label: Ropivacaine 0.75%
arm group type: Active Comparator
description: intrathecal administration of 22.5 mg of Ropivacaine 0.75%
intervention type: Drug
intervention name: Levobupivacaine
description: Comparison of Equipotent doses
arm group label: Levobupivacaine 0.5%
other name: Chirocaine
intervention type: Drug
intervention name: Ropivacaine
description: Comparison of equipotent doses
arm group label: Ropivacaine 0.75%
other name: Naropin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Manazir Athar, M.D
role: Principal Investigator
affiliation: Jawaharlal Nehru Medical College, AMU,Aligarh, India
last name: Syed Moied Ahmed, PhD, M.D
role: Study Director
affiliation: Jawaharlal Nehru Medical College, AMU, Aligarh, India
last name: Masood H Siddiqi, M.S
role: Study Director
affiliation: Jawaharlal Nehru Medical College, AMU, Aligarh, India
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Aligarh Muslim University
investigator full name: MANAZIR ATHAR
investigator title: Doctor
mesh term: Ropivacaine
mesh term: Levobupivacaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Exact baricity was not known as Specific gravity was not measured; Quality of anaesthesia was not assessed
point of contact: 