<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/NCT03302689</url>
  </required_header>
  <id_info>
    <org_study_id>LeRoTAP</org_study_id>
    <nct_id>NCT03302689</nct_id>
  </id_info>
  <brief_title>Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section</brief_title>
  <official_title>The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandr Ronenson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tver Regional Perinatal Center</source>
  <oversight_info>
    <has_dmc>No</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>
      Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine&#xD;
      for postoperative analgesia using TAP-block&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. VAS score during the first 12 hours&#xD;
&#xD;
        2. Determine which drug is more effective for postoperative analgesia in the first 12 hours&#xD;
           after surgery&#xD;
&#xD;
        3. Side effects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For TAP-block was used Hirokain® (Levobupivacaine) . Injectable solution 7.5 mg / ml; ampoule&#xD;
      polypropylene 10 ml, a pack of cardboard 10; No. ЛП-003106, 2015-07-21 to 2020-07-21 from&#xD;
      EbbVi Ltd. (Russia); manufacturer: Kurida AS (Norway); Packer: AbbVi S.r.l. (Italy), or&#xD;
      Ropivacaine Kabi (Ropivacaine Kabi) (Ropivacaine) Solution for injection 7.5 mg / ml; ampoule&#xD;
      polypropylene 1 10 ml, a pack of cardboard 5; EAN code: 4607085481524; No. ЛП-002897,&#xD;
      2015-03-04 to 2020-03-04 from Fresenius Kabi Deutschland GmbH (Germany); manufacturer:&#xD;
      Fresenius Kabi Norge (Norway).&#xD;
&#xD;
      Both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml.&#xD;
&#xD;
      It was performed by TAP-block in-plain with a 22G needle Quincke, on both sides, and 25 ml on&#xD;
      each side was injected.&#xD;
&#xD;
      The pain syndrome was assessed with admission, and every 2 hours during the first 12 hours&#xD;
      after the operation, using a digital scale on the VAS.&#xD;
&#xD;
      All patients received NSAIDs (Ketorol 3 mg IV every 6 hours from admission)&#xD;
&#xD;
      Additionally:&#xD;
&#xD;
      Paracetamol IV infusion 100 ml with VAS = 4 score, lockout time 6 hours Tramadol 5% - 2 ml IM&#xD;
      with VAS = or &gt; 5 score, lockout time 6 hours&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 25, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 23, 2017</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>Two groups of women after cesarean section under spinal anesthesia</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Women after the operation do not know what drug they injected with TAP-block The researcher does not know what type of drug is injected</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Level of pain</measure>
    <time_frame>12 hours</time_frame>
    <description>Measurement of pain on a VAS scale (from 0 to 10 points)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The need for additional analgesics (Paracetamol, Tramadol)</measure>
    <time_frame>12 hours</time_frame>
    <description>Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAP-block with Ropivacaine Solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levobupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAP-block with Levobupivacaine Solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine Solution</intervention_name>
    <description>TAP-block with Levobupivacaine 0,3% - 25 ml from each side</description>
    <arm_group_label>Levobupivacaine</arm_group_label>
    <other_name>Levo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine Solution</intervention_name>
    <description>TAP-block with Ropivacaine 0,3% - 25 ml from each side</description>
    <arm_group_label>Ropivacaine</arm_group_label>
    <other_name>Rop</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cesarean section pfannenstiel incision under spinal anesthesia&#xD;
&#xD;
          -  Spinal anesthesia with Bupivacaine heavy 0,5%&#xD;
&#xD;
          -  Without any adjuvants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any other anesthesia exept spinal&#xD;
&#xD;
          -  Any other surgical incision&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tver Regional Perinatal Center</name>
      <address>
        <city>Tver</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tver Regional Perinatal Center</investigator_affiliation>
    <investigator_full_name>Alexandr Ronenson</investigator_full_name>
    <investigator_title>Head of department of Anaesthesiology and Intensive Care Unit</investigator_title>
  </responsible_party>
  <keyword>TAP-block</keyword>
  <keyword>VAS of pain</keyword>
  <keyword>Cesarean section</keyword>
  <keyword>Postoperative analgesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03302689
org study id: LeRoTAP
nct id: NCT03302689
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine
      for postoperative analgesia using TAP-block

      Objectives:

        1. VAS score during the first 12 hours

        2. Determine which drug is more effective for postoperative analgesia in the first 12 hours
           after surgery

        3. Side effects
For TAP-block was used Hirokain® (Levobupivacaine) . Injectable solution 7.5 mg / ml; ampoule
      polypropylene 10 ml, a pack of cardboard 10; No. ЛП-003106, 2015-07-21 to 2020-07-21 from
      EbbVi Ltd. (Russia); manufacturer: Kurida AS (Norway); Packer: AbbVi S.r.l. (Italy), or
      Ropivacaine Kabi (Ropivacaine Kabi) (Ropivacaine) Solution for injection 7.5 mg / ml; ampoule
      polypropylene 1 10 ml, a pack of cardboard 5; EAN code: 4607085481524; No. ЛП-002897,
      2015-03-04 to 2020-03-04 from Fresenius Kabi Deutschland GmbH (Germany); manufacturer:
      Fresenius Kabi Norge (Norway).

      Both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml.

      It was performed by TAP-block in-plain with a 22G needle Quincke, on both sides, and 25 ml on
      each side was injected.

      The pain syndrome was assessed with admission, and every 2 hours during the first 12 hours
      after the operation, using a digital scale on the VAS.

      All patients received NSAIDs (Ketorol 3 mg IV every 6 hours from admission)

      Additionally:

      Paracetamol IV infusion 100 ml with VAS = 4 score, lockout time 6 hours Tramadol 5% - 2 ml IM
      with VAS = or > 5 score, lockout time 6 hours
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups of women after cesarean section under spinal anesthesia
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Women after the operation do not know what drug they injected with TAP-block The researcher does not know what type of drug is injected
measure: Level of pain
time frame: 12 hours
description: Measurement of pain on a VAS scale (from 0 to 10 points)
measure: The need for additional analgesics (Paracetamol, Tramadol)
time frame: 12 hours
description: Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores
arm group label: Ropivacaine
arm group type: Experimental
description: TAP-block with Ropivacaine Solution
arm group label: Levobupivacaine
arm group type: Experimental
description: TAP-block with Levobupivacaine Solution
intervention type: Drug
intervention name: Levobupivacaine Solution
description: TAP-block with Levobupivacaine 0,3% - 25 ml from each side
arm group label: Levobupivacaine
other name: Levo
intervention type: Drug
intervention name: Ropivacaine Solution
description: TAP-block with Ropivacaine 0,3% - 25 ml from each side
arm group label: Ropivacaine
other name: Rop
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
responsible party type: Sponsor-Investigator
investigator affiliation: Tver Regional Perinatal Center
investigator full name: Alexandr Ronenson
investigator title: Head of department of Anaesthesiology and Intensive Care Unit
mesh term: Pain, Postoperative
mesh term: Ropivacaine
mesh term: Levobupivacaine
mesh term: Pharmaceutical Solutions
sharing ipd: No