xml: <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/NCT06004648</url>
    </required_header>
    <id_info>
      <org_study_id>107</org_study_id>
      <nct_id>NCT06004648</nct_id>
    </id_info>
    <brief_title>Comparison of Selective Trunk and Supraclavicular Brachial Plexus Blocks</brief_title>
    <official_title>Comparison of Anesthetic and Analgesic Efficacy of Selective Trunk and Supraclavicular Brachial Plexus Blocks in Upper Extremity Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gaziosmanpasa Research and Education Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gaziosmanpasa Research and Education Hospital</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>
        There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow&#xD;
        operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus&#xD;
        methods and the supraclavicular methods for brachial plexus blocks in upper extremity&#xD;
        surgeries will be compared.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Currently, brachial plexus block performed with various approaches is preferred to general&#xD;
        anesthesia due to its advantages in upper extremity surgeries. These advantages can be listed&#xD;
        as protecting the patient's consciousness, minimum effect on breathing, reducing airway&#xD;
        interventions, enabling long-term postoperative pain control, reducing opioid-related side&#xD;
        effects, limiting metabolic and endocrine changes due to surgery, and early discharge of&#xD;
        hospital. The supraclavicular approach has a rapid onset of block and a high success rate.&#xD;
        Close proximity to the pleura is the main disadvantage, but the widespread use of USG in&#xD;
        peripheral blocks has also reduced the risk of complications related to this proximity. In&#xD;
        the selective truncus approach defined by Manoj Kumar Karmakar in 2020, three trunks of the&#xD;
        brachial plexus can be identified separately and selectively blocked under ultrasound&#xD;
        guidance. It has been suggested that sensory/motor block occurs in all ipsilateral upper&#xD;
        extremity dermatomes except T2 by selective blocking of the upper, middle, and lower trunks.&#xD;
        In this study, the selective trunk method and the supraclavicular method will be compared.&#xD;
  &#xD;
        Patients who will undergo upper extremity elbow and below-elbow surgery in the orthopedics&#xD;
        and traumatology operating room will be included in the study. The primary aim of the study&#xD;
        is to compare the success rates of supraclavicular and selective truncus blocks in patients&#xD;
        scheduled for hand, wrist, forearm, and elbow surgery. Comparisons will be made by measuring&#xD;
        the first analgesic time after surgery. Secondary aims are sensory and motor block success&#xD;
        rates between the two methods. The block application time, preparation time for surgery,&#xD;
        number of needle insertions, tourniquet pain, diaphragmatic paralysis rate, complications&#xD;
        (vascular puncture, paresthesia, horner's syndrome, hoarseness, local anesthetic toxicity,&#xD;
        pneumothorax) patient satisfaction, surgeon satisfaction and total analgesic amount at the&#xD;
        end of the postoperative 12 and 24 hours will be recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 28, 2022</start_date>
    <completion_date type="Actual">January 10, 2023</completion_date>
    <primary_completion_date type="Actual">January 10, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>peripheral block success</measure>
      <time_frame>T1: 12 hours after surgery, T2: 24 hours after surgery</time_frame>
      <description>primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparison will be made by measuring the first analgesic time after surgery.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">92</enrollment>
    <condition>Upper Extremity Problem</condition>
    <arm_group>
      <arm_group_label>Supraclavicular nerve block</arm_group_label>
      <description>The high- frequency linear USG probe will be placed in the supraclavicular fossa pointing caudally, and the subclavian artery will be localized by moving it medially and laterally. A characteristic honeycomb plexus will be visualized in the lateral and superficial subclavian artery. Vascular structures will be detected using color Doppler, the first rib will be visualized as hyperechoic structure. After the pleura, which makes a&#xD;
  sliding movement through the patient&amp;#39;s breathing is detected, a 22 gauge, 80 mm scale peripheral block needle will be directed from the lateral to the medial by an in-plane technique. After the sheath punctured, nerves will be determined with triceps, biceps, and wrist motor activity by using a nerve stimulator, and then 15 ml of 0.5% bupivacaine will be injected between the 1st rib and the lower trunk.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Selective Trunk Block</arm_group_label>
      <description>Sequential ultrasound imaging technique (SUIT) will be used which is shown successfully in identifying individual elements of the brachial plexus. The neural complex of the upper trunk, middle trunk, and C8 ventral ramus, which are superficial to the T1 TP-1.rip complex will be defined. The first injections contains 8 ml and 7 ml 0.5% bupivacaine will be made as, close to the upper trunk(8ml) and middle trunk(7ml) in the interscalene groove. Then the needle will be completely withdrawn.The ultrasound probe will be placed caudally in the supraclavicular fossa. After providing the optimal view of the lower trunk in the corner pocket, 10 ml of 0.5% bupivacaine will be injected between the first rib and lower trunk.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Upper extremity surgery</intervention_name>
      <description>Comparison of 2 different peripheral nerve blocks</description>
      <arm_group_label>Selective Trunk Block</arm_group_label>
      <arm_group_label>Supraclavicular nerve block</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Orthopedic surgery patients between 18-65 years of age who needs upper extremity elbow and&#xD;
          below-elbow surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Patients undergoing upper extremity elbow and below-elbow surgery in the orthopedics and&#xD;
          traumatology operating room&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient's refusal&#xD;
  &#xD;
            -  ASA IV,&#xD;
  &#xD;
            -  Pregnancy,&#xD;
  &#xD;
            -  Neuromuscular disease,&#xD;
  &#xD;
            -  Peripheral neuropathy&#xD;
  &#xD;
            -  Bleeding disorders,&#xD;
  &#xD;
            -  Local anesthetic allergy,&#xD;
  &#xD;
            -  Infection in the block area&#xD;
  &#xD;
            -  Operations without using a tourniquet&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ZÜHAL ÇAVUŞ</last_name>
      <role>Study Chair</role>
      <affiliation>gaziosmanpasa TREH</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Zühal Çavuş</name>
        <address>
          <city>Istanbul</city>
          <state>Gaziosmanpaşa</state>
          <zip>34255</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gaziosmanpasa Research and Education Hospital</investigator_affiliation>
      <investigator_full_name>Döndü Genc Moralar</investigator_full_name>
      <investigator_title>head of anesthesiology,Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>nerve block</keyword>
    <keyword>Pain, Postoperative</keyword>
    <keyword>Anesthetics, Local</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004648
  org study id: 107
  nct id: NCT06004648
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow
        operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus
        methods and the supraclavicular methods for brachial plexus blocks in upper extremity
        surgeries will be compared.
  Currently, brachial plexus block performed with various approaches is preferred to general
        anesthesia due to its advantages in upper extremity surgeries. These advantages can be listed
        as protecting the patient's consciousness, minimum effect on breathing, reducing airway
        interventions, enabling long-term postoperative pain control, reducing opioid-related side
        effects, limiting metabolic and endocrine changes due to surgery, and early discharge of
        hospital. The supraclavicular approach has a rapid onset of block and a high success rate.
        Close proximity to the pleura is the main disadvantage, but the widespread use of USG in
        peripheral blocks has also reduced the risk of complications related to this proximity. In
        the selective truncus approach defined by Manoj Kumar Karmakar in 2020, three trunks of the
        brachial plexus can be identified separately and selectively blocked under ultrasound
        guidance. It has been suggested that sensory/motor block occurs in all ipsilateral upper
        extremity dermatomes except T2 by selective blocking of the upper, middle, and lower trunks.
        In this study, the selective trunk method and the supraclavicular method will be compared.
  
        Patients who will undergo upper extremity elbow and below-elbow surgery in the orthopedics
        and traumatology operating room will be included in the study. The primary aim of the study
        is to compare the success rates of supraclavicular and selective truncus blocks in patients
        scheduled for hand, wrist, forearm, and elbow surgery. Comparisons will be made by measuring
        the first analgesic time after surgery. Secondary aims are sensory and motor block success
        rates between the two methods. The block application time, preparation time for surgery,
        number of needle insertions, tourniquet pain, diaphragmatic paralysis rate, complications
        (vascular puncture, paresthesia, horner's syndrome, hoarseness, local anesthetic toxicity,
        pneumothorax) patient satisfaction, surgeon satisfaction and total analgesic amount at the
        end of the postoperative 12 and 24 hours will be recorded.
  observational model: Other
  time perspective: Prospective
  measure: peripheral block success
  time frame: T1: 12 hours after surgery, T2: 24 hours after surgery
  description: primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparison will be made by measuring the first analgesic time after surgery.
  arm group label: Supraclavicular nerve block
  description: The high- frequency linear USG probe will be placed in the supraclavicular fossa pointing caudally, and the subclavian artery will be localized by moving it medially and laterally. A characteristic honeycomb plexus will be visualized in the lateral and superficial subclavian artery. Vascular structures will be detected using color Doppler, the first rib will be visualized as hyperechoic structure. After the pleura, which makes a
  sliding movement through the patient&#39;s breathing is detected, a 22 gauge, 80 mm scale peripheral block needle will be directed from the lateral to the medial by an in-plane technique. After the sheath punctured, nerves will be determined with triceps, biceps, and wrist motor activity by using a nerve stimulator, and then 15 ml of 0.5% bupivacaine will be injected between the 1st rib and the lower trunk.
  arm group label: Selective Trunk Block
  description: Sequential ultrasound imaging technique (SUIT) will be used which is shown successfully in identifying individual elements of the brachial plexus. The neural complex of the upper trunk, middle trunk, and C8 ventral ramus, which are superficial to the T1 TP-1.rip complex will be defined. The first injections contains 8 ml and 7 ml 0.5% bupivacaine will be made as, close to the upper trunk(8ml) and middle trunk(7ml) in the interscalene groove. Then the needle will be completely withdrawn.The ultrasound probe will be placed caudally in the supraclavicular fossa. After providing the optimal view of the lower trunk in the corner pocket, 10 ml of 0.5% bupivacaine will be injected between the first rib and lower trunk.
  intervention type: Procedure
  intervention name: Upper extremity surgery
  description: Comparison of 2 different peripheral nerve blocks
  arm group label: Selective Trunk Block
  arm group label: Supraclavicular nerve block
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: ZÜHAL ÇAVUŞ
  role: Study Chair
  affiliation: gaziosmanpasa TREH
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Gaziosmanpasa Research and Education Hospital
  investigator full name: Döndü Genc Moralar
  investigator title: head of anesthesiology,Clinical Professor