<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/NCT03265886</url>
  </required_header>
  <id_info>
    <org_study_id>MFM-IRB, MS/17.05.143</org_study_id>
    <nct_id>NCT03265886</nct_id>
  </id_info>
  <brief_title>The Influence of Warm Bupivacaine on Supraclavicular Plexus Block Characteristics</brief_title>
  <official_title>The Influence of Bupivacaine Temperature on Supraclavicular Plexus Block Characteristics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Despite PH adjustment of local anesthetic solution improves the quality of the block in all&#xD;
      respects with special advantage of early onset of sensory and motor block, adequate level of&#xD;
      analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should&#xD;
      have the same effect which have not been evaluated on supraclavicular plexus block for upper&#xD;
      limb surgery.&#xD;
&#xD;
      The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor&#xD;
      block onset and prolong the duration of analgesia when compared to bupivacaine at operating&#xD;
      room temperature.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus&#xD;
      bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular&#xD;
      plexus block characteristics as regard sensory block onset time, motor block onset time,&#xD;
      duration of sensory and motor block , effective duration of analgesia, total analgesics&#xD;
      requirement, complications and side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">September 17, 2018</completion_date>
  <primary_completion_date type="Actual">June 9, 2018</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Double-blind design</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time to onset of sensory block</measure>
    <time_frame>for 30 min following injection</time_frame>
    <description>defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to onset of motor block</measure>
    <time_frame>For 3 hours after the injection of local anesthetic</time_frame>
    <description>defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>For 3 hours after the injection of local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>For 3 hours after the injection of local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation in the peripheral blood</measure>
    <time_frame>For 3 hours after the injection of local anesthetic</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of sensory block</measure>
    <time_frame>For 24 hours after the injection of local anesthetic</time_frame>
    <description>defined as the interval between end of injection and complete end of sensory block (score=2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of motor block</measure>
    <time_frame>For 24 hours after the injection of local anesthetic</time_frame>
    <description>defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The severity of postoperative pain</measure>
    <time_frame>For 24 hours after the injection of local anesthetic</time_frame>
    <description>will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for first analgesic request</measure>
    <time_frame>For 24 hours after the injection of local anesthetic</time_frame>
    <description>Time to the first receiving of rescue analgesic from the time of blockade</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total analgesics received</measure>
    <time_frame>for 24 hrs after the injection of local anesthetic</time_frame>
    <description>Cumulative use of rescue analgesics after performing the blockade</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Score</measure>
    <time_frame>for 48 hrs after the injection of local anesthetic</time_frame>
    <description>Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Surgery to the Distal One Third of the Upper Limb</condition>
  <arm_group>
    <arm_group_label>Warm bupivacaine at (37°c)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Warmed bupivacaine at body temperature will be administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine at operating room temperature (23°c)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine at temperature of 23°C will be administered</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warm bupivacaine at (37°c)</intervention_name>
    <description>Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes. The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.</description>
    <arm_group_label>Warm bupivacaine at (37°c)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine at operating room temperature (23°c)</intervention_name>
    <description>Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C. The empty syringes and needles will be held in the same temperature before use.</description>
    <arm_group_label>Bupivacaine at operating room temperature (23°c)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical class I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Neuromuscular diseases (as myopathies, myasthenia gravies…)&#xD;
&#xD;
          -  Hematological diseases&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Coagulation abnormality.&#xD;
&#xD;
          -  Psychiatric diseases.&#xD;
&#xD;
          -  Local skin infection&#xD;
&#xD;
          -  Sepsis at site of the block.&#xD;
&#xD;
          -  Known intolerance to the study drugs.&#xD;
&#xD;
          -  Body Mass Index &gt; 40 Kg/m2.&#xD;
&#xD;
          -  Bilateral upper limb injury to be performed at the same procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Y Makharita, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University, Faculty of Medicine</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 3, 2019</last_update_submitted>
  <last_update_submitted_qc>November 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>do not mind sharing raw data but after its publication not before.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT03265886
org study id: MFM-IRB, MS/17.05.143
nct id: NCT03265886
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite PH adjustment of local anesthetic solution improves the quality of the block in all
      respects with special advantage of early onset of sensory and motor block, adequate level of
      analgesia, and prolongation of duration of block, the effect of warmed bupivacaine should
      have the same effect which have not been evaluated on supraclavicular plexus block for upper
      limb surgery.

      The warmed bupivacaine used in supraclavicular plexus block may reduce sensory and motor
      block onset and prolong the duration of analgesia when compared to bupivacaine at operating
      room temperature.
The aim of this study is to compare the effect of warm bupivacaine 0.5% at 37◦C versus
      bupivacaine 0.5% at operating room temperature at 23◦C on ultrasound-guided supraclavicular
      plexus block characteristics as regard sensory block onset time, motor block onset time,
      duration of sensory and motor block , effective duration of analgesia, total analgesics
      requirement, complications and side effects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
masking description: Double-blind design
measure: Time to onset of sensory block
time frame: for 30 min following injection
description: defined as the time interval between the end of local anesthetic injection and the loss of sensation to pinprick (sensory score = 1)
measure: Time to onset of motor block
time frame: For 3 hours after the injection of local anesthetic
description: defined as time interval between the end of local anesthetic injection and (motor score = 1) in the distributions of all 4 peripheral nerves.
measure: Heart rate
time frame: For 3 hours after the injection of local anesthetic
measure: Blood pressure
time frame: For 3 hours after the injection of local anesthetic
measure: oxygen saturation in the peripheral blood
time frame: For 3 hours after the injection of local anesthetic
measure: Duration of sensory block
time frame: For 24 hours after the injection of local anesthetic
description: defined as the interval between end of injection and complete end of sensory block (score=2)
measure: Duration of motor block
time frame: For 24 hours after the injection of local anesthetic
description: defined as the interval between end of injection and complete recovery of normal motor function (score=0), respectively.
measure: The severity of postoperative pain
time frame: For 24 hours after the injection of local anesthetic
description: will be measured and recorded by using a 100-cm visual analog scale (VAS) for pain, where 0 is equal to no pain and 100 indicates the worst possible pain.
measure: Time for first analgesic request
time frame: For 24 hours after the injection of local anesthetic
description: Time to the first receiving of rescue analgesic from the time of blockade
measure: Total analgesics received
time frame: for 24 hrs after the injection of local anesthetic
description: Cumulative use of rescue analgesics after performing the blockade
measure: Satisfaction Score
time frame: for 48 hrs after the injection of local anesthetic
description: Using score including 5-Excellent, 4-Very Good, 3-Good, 2-Fair, and 1-Poor
arm group label: Warm bupivacaine at (37°c)
arm group type: Experimental
description: Warmed bupivacaine at body temperature will be administered
arm group label: Bupivacaine at operating room temperature (23°c)
arm group type: Active Comparator
description: Bupivacaine at temperature of 23°C will be administered
intervention type: Drug
intervention name: Warm bupivacaine at (37°c)
description: Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes. The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.
arm group label: Warm bupivacaine at (37°c)
intervention type: Drug
intervention name: Bupivacaine at operating room temperature (23°c)
description: Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C. The empty syringes and needles will be held in the same temperature before use.
arm group label: Bupivacaine at operating room temperature (23°c)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Mohamed Y Makharita, MD
role: Study Chair
affiliation: Professor of Anesthesia and Surgical Intensive Care
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Bupivacaine
sharing ipd: Yes
ipd description: do not mind sharing raw data but after its publication not before.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)