<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/NCT04498923</url>
  </required_header>
  <id_info>
    <org_study_id>LNMY-FPGE- ANESTHESIOLOGY-DBBA</org_study_id>
    <nct_id>NCT04498923</nct_id>
  </id_info>
  <brief_title>Duration of Blockade of Peripheral Nerves With Bupivacaine Depending of the Adjuvants</brief_title>
  <acronym>DBBA</acronym>
  <official_title>Duration of Blockade of Peripheral Nerves With Low Concentrated Bupivacaine Solution Depending of the Adjuvants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lviv National Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lviv National Medical University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main aim of the investigator's study is to propose combination of local anesthetics and&#xD;
      adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative&#xD;
      analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral nerve plexuses blocks are performing as a component of analgesia in patients&#xD;
      undergoing orthopedic surgery on the upper or lower extremities. Patients are divided into&#xD;
      two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose&#xD;
      blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone&#xD;
      0.02%; Group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375%&#xD;
      together with dexamethasone 0.02% and epinephrine 0.00018%. The duration of the blockade is&#xD;
      estimated by puncturing the skin with a needle. The intensity of pain is assessed at 6, 12,&#xD;
      24 and 36 hours after blockade using Visual analog scale (VAS). The amount of narcotic&#xD;
      anesthetic used in the postoperative period is also recorded. In addition, patients underwent&#xD;
      electromyography of the innervation area of the blocked nerve before the surgery and 24 and&#xD;
      36 hours after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">April 5, 2022</completion_date>
  <primary_completion_date type="Actual">April 5, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The duration of blockade</measure>
    <time_frame>6th, 12th, 24th and 36th hours after blockade</time_frame>
    <description>The duration of the blockade was estimated by puncturing the skin with a needle every hour. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amount of narcotic anesthetic used in the postoperative period</measure>
    <time_frame>48 hour after surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">68</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Peripheral Neuropathy</condition>
  <condition>Fractures of the Upper Limb</condition>
  <condition>Fracture of the Lower Limb (Except Hip), Initial Encounter</condition>
  <condition>Intraoperative Hypotension</condition>
  <condition>Intraoperative Hypertension</condition>
  <condition>Pain Syndrome</condition>
  <condition>Anesthesia</condition>
  <condition>Anesthesia, Local</condition>
  <condition>Local Anesthetic Systemic Toxicity</condition>
  <arm_group>
    <arm_group_label>Bupivacaine with dexamethasone</arm_group_label>
    <description>Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator.&#xD;
Twenty milliliters solution of bupivacaine 0,375% with dexamethasone was injected for one plexus or peripheral nerve.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine with dexamethasone and epinephrine</arm_group_label>
    <description>Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator.&#xD;
Twenty milliliters solution of bupivacaine 0,375% with dexamethasone 0,02% and epinephrine 0,00018% was injected for one plexus or peripheral nerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine, dexamethasone, epinephrine</intervention_name>
    <description>Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg</description>
    <arm_group_label>Bupivacaine with dexamethasone</arm_group_label>
    <arm_group_label>Bupivacaine with dexamethasone and epinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing orthopedic surgery on the upper and lower extremities in the&#xD;
        Regional Center of Orthopedics, Traumatology and Vertebrology of Rivne Oblast State&#xD;
        Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing upper or lower extremity orthopedic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes mellitus;&#xD;
&#xD;
          -  diseases of the peripheral nerv system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maksym Barsa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Сlinical resident</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rivne Oblast State Hospital</name>
      <address>
        <city>Rivne</city>
        <state>Rivne Region</state>
        <zip>33000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ukraine</country>
  </location_countries>
  <link>
    <url>https://orcid.org/0000-0002-2578-4935</url>
    <description>ORCID</description>
  </link>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lviv National Medical University</investigator_affiliation>
    <investigator_full_name>Maksym Barsa</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Regional anesthesia</keyword>
  <keyword>Pain management</keyword>
  <keyword>Local anesthetic</keyword>
  <keyword>Electromyography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04498923
org study id: LNMY-FPGE- ANESTHESIOLOGY-DBBA
nct id: NCT04498923
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The main aim of the investigator's study is to propose combination of local anesthetics and
      adjuvants that provides both adequate anesthesia during surgery and prolonged post-operative
      analgesia.
Peripheral nerve plexuses blocks are performing as a component of analgesia in patients
      undergoing orthopedic surgery on the upper or lower extremities. Patients are divided into
      two groups depending on the adjuvant to the local anesthetic: 1st group - patients whose
      blockade is performed with a solution of bupivacaine 0.375% together with dexamethasone
      0.02%; Group 2 - patients whose blockade is performed with a solution of bupivacaine 0.375%
      together with dexamethasone 0.02% and epinephrine 0.00018%. The duration of the blockade is
      estimated by puncturing the skin with a needle. The intensity of pain is assessed at 6, 12,
      24 and 36 hours after blockade using Visual analog scale (VAS). The amount of narcotic
      anesthetic used in the postoperative period is also recorded. In addition, patients underwent
      electromyography of the innervation area of the blocked nerve before the surgery and 24 and
      36 hours after surgery.
observational model: Cohort
time perspective: Prospective
measure: The duration of blockade
time frame: 6th, 12th, 24th and 36th hours after blockade
description: The duration of the blockade was estimated by puncturing the skin with a needle every hour. In addition, patients underwent electromyography of the innervation area of the blocked nerve before the surgery and 24 and 36 hours after surgery.
measure: The amount of narcotic anesthetic used in the postoperative period
time frame: 48 hour after surgery
arm group label: Bupivacaine with dexamethasone
description: Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator.
Twenty milliliters solution of bupivacaine 0,375% with dexamethasone was injected for one plexus or peripheral nerve.
arm group label: Bupivacaine with dexamethasone and epinephrine
description: Ultrasound guided peripheral nerve block for upper or lower extremity was performed before orthopedic surgery using neurostimulator.
Twenty milliliters solution of bupivacaine 0,375% with dexamethasone 0,02% and epinephrine 0,00018% was injected for one plexus or peripheral nerve.
intervention type: Drug
intervention name: Bupivacaine, dexamethasone, epinephrine
description: Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg
arm group label: Bupivacaine with dexamethasone
arm group label: Bupivacaine with dexamethasone and epinephrine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Maksym Barsa
role: Principal Investigator
affiliation: Сlinical resident
facility: 
country: Ukraine
url: https://orcid.org/0000-0002-2578-4935
description: ORCID
responsible party type: Principal Investigator
investigator affiliation: Lviv National Medical University
investigator full name: Maksym Barsa
investigator title: Principal Investigator
mesh term: Peripheral Nervous System Diseases
mesh term: Hypotension
mesh term: Fractures, Bone
mesh term: Dexamethasone
mesh term: Epinephrine
mesh term: Bupivacaine
sharing ipd: Undecided