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/NCT05991375</url>
    </required_header>
    <id_info>
      <org_study_id>SIUT-ERC-2020/PA-257</org_study_id>
      <nct_id>NCT05991375</nct_id>
    </id_info>
    <brief_title>Comparison of Efficacy of Bupivacaine in Supraclavicular Block With or Without Dexmedetomidine</brief_title>
    <official_title>A Randomized Comparative Evaluation Of The Effects Of Dexmedetomidine As An Adjuvant With Bupivacaine In Supraclavicular Block In Chronic Renal Failure Patients Undergoing Basilic Vein Transposition Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sindh Institute of Urology and Transplantation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sindh Institute of Urology and Transplantation</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        End-stage renal disease (ESRD) patients are coming for Brachial vein transposition surgery.&#xD;
        Patients were randomly allocated using sealed opaque envelope bearing A- (Injection&#xD;
        bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL&#xD;
        plus dexmedetomidine I ug/kg diluted to 2 ml).&#xD;
  &#xD;
        Supraclavicular block under ultrasound and nerve stimulator guidance was performed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was conducted after approval of the institutional ethical review committee and&#xD;
        then from College of Physicians and Surgeons Pakistan. Patients with end stage renal disease&#xD;
        (ESRD) coming for Brachial vein transposition surgery, and fulfilling the inclusion criteria&#xD;
        were enrolled in this study. All patients were instructed not to consume solid food after&#xD;
        midnight prior to surgery. A brief history of demographic data was taken from each patient.&#xD;
        Each participant's height in meters was measured using wall mounted scale, weight in kg using&#xD;
        a weighing machine, and BMI kg/m² was noted prior to operation. The findings of quantitative&#xD;
        variables (age, height, weight, sensory blockade, motor blockade and qualitative variables&#xD;
        (gender, diabetes mellitus type II, hypertension, and dyslipidemia) were entered in the&#xD;
        proforma attached as an annexure. Patients were randomly allocated using sealed opaque&#xD;
        envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and&#xD;
        B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml). Only the&#xD;
        anaesthesiologists for the specific case were aware of the treatment allocation until the end&#xD;
        of the surgical procedure. The investigator for assessing the block and the other outcome&#xD;
        variables, remained blinded to the patient's group allocation.&#xD;
  &#xD;
        Routine monitoring of heart rate &amp; rhythm by ECG, and arterial blood pressure using&#xD;
        non-invasive blood pressure (NIBP) including systolic, diastolic &amp; mean arterial blood&#xD;
        pressure, and peripheral oxygen saturation (SPO2) using a pulse oximeter was performed on&#xD;
        each patient. The supraclavicular brachial plexus block was performed under the supervision&#xD;
        of a consultant anaesthesiologist in a supine position with a head up to 45 degrees. An&#xD;
        Intravenous (IV) line was established and the skin was disinfected and a linear probe, high&#xD;
        frequency 12 MHz was placed firmly over the supraclavicular fossa, the probe was positioned&#xD;
        in the transverse plane immediately superior to the clavicle at approximately its midpoint.&#xD;
        The probe was tilted caudally to obtain a cross sectional view of the subclavian artery. The&#xD;
        brachial plexus was seen as a collection of hypo-echoic oval structures lateral and&#xD;
        superficial to the artery. Using a 25 gauge needle 1 to 2 ml of 2% lidocaine was locally&#xD;
        infiltrated into the skin 1 cm lateral to the probe to decrease the discomfort during needle&#xD;
        insertion. A 50 mm or 80 mm length, short bevel, insulated nerve stimulator needle was used.&#xD;
        Peripheral nerve stimulation (PNS) is an additional way of confirming nerve location. Initial&#xD;
        settings was set at 0.5 mA current, 2 Hz frequency, and pulse width of 0.1 milliseconds.&#xD;
        Close approximation to the divisions of brachial plexus was confirmed by getting nerve&#xD;
        stimulation on 0.3 mA current. The needle was advanced along the long axis in the same plane&#xD;
        as the ultrasound beam. The shaft and tip was visualized in real time as the needle was&#xD;
        advanced towards the target nerves. The drug in either group was injected under direct vision&#xD;
        of ultrasound beams and by confirming with nerve stimulation. Sensory blockade and motor&#xD;
        blockade was assessed every 3 minutes. Time of onset of sensory and motor blockade and&#xD;
        duration of sensory and motor blockade were noted as per operational definition.&#xD;
        Postoperative pain was assessed with visual analogue scale (VAS). Patients were asked to mark&#xD;
        a point on the line that matches the intensity of pain on the Visual Analogue Score hourly&#xD;
        for 4 hours post operatively. Those patients having arm pain equal to or greater than 4 on&#xD;
        VAS, were given rescue analgesic (inj. Paracetamol (15mg/kg 1/V) and duration of analgesia&#xD;
        were noted as per operational definition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 15, 2021</start_date>
    <completion_date type="Actual">April 30, 2021</completion_date>
    <primary_completion_date type="Actual">April 30, 2021</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, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain score</measure>
      <time_frame>0-4 hours</time_frame>
      <description>Visual Analogue Scale for pain&#xD;
  0-1-2-3-4-5-6-7-8-9-10&#xD;
  Pain score 0 means no pain, Pain score 1 to 3 means mild pain, Pain score 4-6 means moderate pain, Pain score 7-9 means severe pain, Pain score 10 means most excruciating pain one can have,</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>0-4 hours</time_frame>
      <description>Heart rate as per vitals monitoring device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mean blood pressure</measure>
      <time_frame>0-4 hours</time_frame>
      <description>as measured by non-invasive blood pressure monitoring device</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">108</enrollment>
    <condition>Pain</condition>
    <arm_group>
      <arm_group_label>BUPIvacaine 0.25%</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>(Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) making a total volume of local anaesthetic solution equal to 30 mL</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bupivacaine0.25%+DEX</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml) making a total volume of local anaesthetic solution equal to 30 mL</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>DEXmedetomidine</intervention_name>
      <description>28 mL of Bupivacain 0.25% was mixed with Dexmedetomidine 1 microgram/kg body weight mixed in 2 mL = total volume 30 mL</description>
      <arm_group_label>Bupivacaine0.25%+DEX</arm_group_label>
      <other_name>DEX</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>saline</intervention_name>
      <description>28 mL of Bupivacain 0.25% was mixed with 2 mL of Normal saline = total volume 30 mL</description>
      <arm_group_label>BUPIvacaine 0.25%</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chronic renal failure patients who will undergo elective basilic vein transposition&#xD;
               surgery&#xD;
  &#xD;
            -  Either gender&#xD;
  &#xD;
            -  ASA III&#xD;
  &#xD;
            -  Age 18-65 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mentally challenged&#xD;
  &#xD;
            -  Pregnancy.&#xD;
  &#xD;
            -  Hypersensitivity to bupivacaine or dexmedetomidine&#xD;
  &#xD;
            -  Seizures&#xD;
  &#xD;
            -  Neck swelling (hematoma, lipoma, tumor, thyroid)&#xD;
  &#xD;
            -  Neuromuscular dystrophy&#xD;
  &#xD;
            -  Bleeding disorders&#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>Fauzia Ali, FCPS</last_name>
      <role>Study Chair</role>
      <affiliation>Professor Dept of Anaesthesiology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Syed Muhammad Abbas</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>74200</zip>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sindh Institute of Urology and Transplantation</investigator_affiliation>
      <investigator_full_name>Syed Muhammad Abbas</investigator_full_name>
      <investigator_title>Associate Professor, Department of Anaesthesia</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexmedetomidine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05991375
  org study id: SIUT-ERC-2020/PA-257
  nct id: NCT05991375
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  End-stage renal disease (ESRD) patients are coming for Brachial vein transposition surgery.
        Patients were randomly allocated using sealed opaque envelope bearing A- (Injection
        bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and B-Injection bupivacaine (0.25%) 28 mL
        plus dexmedetomidine I ug/kg diluted to 2 ml).
  
        Supraclavicular block under ultrasound and nerve stimulator guidance was performed.
  This study was conducted after approval of the institutional ethical review committee and
        then from College of Physicians and Surgeons Pakistan. Patients with end stage renal disease
        (ESRD) coming for Brachial vein transposition surgery, and fulfilling the inclusion criteria
        were enrolled in this study. All patients were instructed not to consume solid food after
        midnight prior to surgery. A brief history of demographic data was taken from each patient.
        Each participant's height in meters was measured using wall mounted scale, weight in kg using
        a weighing machine, and BMI kg/m² was noted prior to operation. The findings of quantitative
        variables (age, height, weight, sensory blockade, motor blockade and qualitative variables
        (gender, diabetes mellitus type II, hypertension, and dyslipidemia) were entered in the
        proforma attached as an annexure. Patients were randomly allocated using sealed opaque
        envelope bearing A- (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) and
        B-Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml). Only the
        anaesthesiologists for the specific case were aware of the treatment allocation until the end
        of the surgical procedure. The investigator for assessing the block and the other outcome
        variables, remained blinded to the patient's group allocation.
  
        Routine monitoring of heart rate & rhythm by ECG, and arterial blood pressure using
        non-invasive blood pressure (NIBP) including systolic, diastolic & mean arterial blood
        pressure, and peripheral oxygen saturation (SPO2) using a pulse oximeter was performed on
        each patient. The supraclavicular brachial plexus block was performed under the supervision
        of a consultant anaesthesiologist in a supine position with a head up to 45 degrees. An
        Intravenous (IV) line was established and the skin was disinfected and a linear probe, high
        frequency 12 MHz was placed firmly over the supraclavicular fossa, the probe was positioned
        in the transverse plane immediately superior to the clavicle at approximately its midpoint.
        The probe was tilted caudally to obtain a cross sectional view of the subclavian artery. The
        brachial plexus was seen as a collection of hypo-echoic oval structures lateral and
        superficial to the artery. Using a 25 gauge needle 1 to 2 ml of 2% lidocaine was locally
        infiltrated into the skin 1 cm lateral to the probe to decrease the discomfort during needle
        insertion. A 50 mm or 80 mm length, short bevel, insulated nerve stimulator needle was used.
        Peripheral nerve stimulation (PNS) is an additional way of confirming nerve location. Initial
        settings was set at 0.5 mA current, 2 Hz frequency, and pulse width of 0.1 milliseconds.
        Close approximation to the divisions of brachial plexus was confirmed by getting nerve
        stimulation on 0.3 mA current. The needle was advanced along the long axis in the same plane
        as the ultrasound beam. The shaft and tip was visualized in real time as the needle was
        advanced towards the target nerves. The drug in either group was injected under direct vision
        of ultrasound beams and by confirming with nerve stimulation. Sensory blockade and motor
        blockade was assessed every 3 minutes. Time of onset of sensory and motor blockade and
        duration of sensory and motor blockade were noted as per operational definition.
        Postoperative pain was assessed with visual analogue scale (VAS). Patients were asked to mark
        a point on the line that matches the intensity of pain on the Visual Analogue Score hourly
        for 4 hours post operatively. Those patients having arm pain equal to or greater than 4 on
        VAS, were given rescue analgesic (inj. Paracetamol (15mg/kg 1/V) and duration of analgesia
        were noted as per operational definition.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Pain score
  time frame: 0-4 hours
  description: Visual Analogue Scale for pain
  0-1-2-3-4-5-6-7-8-9-10
  Pain score 0 means no pain, Pain score 1 to 3 means mild pain, Pain score 4-6 means moderate pain, Pain score 7-9 means severe pain, Pain score 10 means most excruciating pain one can have,
  measure: Heart rate
  time frame: 0-4 hours
  description: Heart rate as per vitals monitoring device
  measure: Mean blood pressure
  time frame: 0-4 hours
  description: as measured by non-invasive blood pressure monitoring device
  arm group label: BUPIvacaine 0.25%
  arm group type: Active Comparator
  description: (Injection bupivacaine (0.25%) 28 ml plus 2 ml. normal saline) making a total volume of local anaesthetic solution equal to 30 mL
  arm group label: Bupivacaine0.25%+DEX
  arm group type: Experimental
  description: Injection bupivacaine (0.25%) 28 mL plus dexmedetomidine I ug/kg diluted to 2 ml) making a total volume of local anaesthetic solution equal to 30 mL
  intervention type: Drug
  intervention name: DEXmedetomidine
  description: 28 mL of Bupivacain 0.25% was mixed with Dexmedetomidine 1 microgram/kg body weight mixed in 2 mL = total volume 30 mL
  arm group label: Bupivacaine0.25%+DEX
  other name: DEX
  intervention type: Other
  intervention name: saline
  description: 28 mL of Bupivacain 0.25% was mixed with 2 mL of Normal saline = total volume 30 mL
  arm group label: BUPIvacaine 0.25%
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Fauzia Ali, FCPS
  role: Study Chair
  affiliation: Professor Dept of Anaesthesiology
  facility: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Sindh Institute of Urology and Transplantation
  investigator full name: Syed Muhammad Abbas
  investigator title: Associate Professor, Department of Anaesthesia
  mesh term: Dexmedetomidine