<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/NCT03790163</url>
  </required_header>
  <id_info>
    <org_study_id>MFM.IRB,R/18.11.340</org_study_id>
    <nct_id>NCT03790163</nct_id>
  </id_info>
  <brief_title>The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia</brief_title>
  <official_title>The Influence of Different Degrees of Levobupivacaine Temperature on Spinal Anesthesia in Orthopedic Surgeries: Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to evaluate the effect of different temperature on the spinal&#xD;
      anesthesia characteristics and incidence of complications&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Regional anesthesia techniques are also superior to systemic opioids agents with regard the&#xD;
      analgesic profile and adverse effects .Spinal anesthesia is the most commonly used technique&#xD;
      due to its unmatchable reliability,simplicity and cost-effectiveness. It provides a fast and&#xD;
      effective onset of sensory and motor block, excellent muscle relaxation and prolonged&#xD;
      postoperative analgesia .&#xD;
&#xD;
      Bupivacaine is commonly used local anesthetics because of its long duration of action and&#xD;
      combined motor and sensory blockade. However, it has many drawbacks .It has a high propensity&#xD;
      to cause hypotension and bradycardia. There is also cardiac toxicity.Levobupivacaine is an&#xD;
      attractive alternative to bupivacaine because of the lower affinity for cardiac sodium&#xD;
      channels and reducing the risk of cardiac toxicity.Moreover ,the isobaric levobupivacaine had&#xD;
      more stability in cerebrospinal fluid and thus lead to more predictable drug spread,&#xD;
      decreasing the incidence of hypotension and bradycardia. But its main disadvantage is the&#xD;
      delayed onset .&#xD;
&#xD;
      A number of strategies have been used to hasten the onset of local anesthesia .The addition&#xD;
      of fentanyl mixtures of local anesthetics and alkalization of the local anesthetics all&#xD;
      shorten the onset time of sensory block. Recently the warming of the anesthetic agents&#xD;
      (namely, lidocaine and bupivacaine) to 37° C hastens the sensory block in various surgical&#xD;
      settings .&#xD;
&#xD;
      Up till now there is no study suggestive of any appropriate degree of temperature as adjuvant&#xD;
      .Hence the present study will be conducted to evaluate the effect of different temperature on&#xD;
      spinal anesthesia characteristics and the incidence its complication&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 15, 2019</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</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(participant ,care provider)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time to onset of sensory block</measure>
    <time_frame>For 10 minutes following the spinal anesthesia</time_frame>
    <description>Defined as the time interval between the end of spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to the onset of motor block</measure>
    <time_frame>For 10 minutes following the injection of spinal anesthesia</time_frame>
    <description>Defined as the time interval between the end of spinal anesthesia and (motor score=1) within both lower limbs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of sensory block</measure>
    <time_frame>For 24 hours after the spinal anesthesia</time_frame>
    <description>Defined as the interval between the end of spinal anesthesia and complete end of sensory block (sensory score=2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of motor block</measure>
    <time_frame>For 24 hours after the spinal anesthesia</time_frame>
    <description>Defined as the interval between the end of spinal anesthesia and complete recovery of normal motor function (score=0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post spinal shivering</measure>
    <time_frame>for 24 hours after spinal anesthesia</time_frame>
    <description>Post spinal shivering will be graded using a scale ( score 0=no shivering ,score 1= no visible muscle activity ,but one or more of piloerection, score 2=muscular activity in only one muscle group,score 3=moderate muscular activity in more than one muscle group but not generalized shaking ,score 4=violent muscular activity that involves entire body )</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Spinal Anesthetic Toxicity</condition>
  <arm_group>
    <arm_group_label>levobupivacaine at ( 23˚C)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Levobupivacine hydrochloride at ( 23˚C) will be received 3.5 ml levobupivacaine at the operating room temperature 23˚C will be administered</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warm levobupivacaine at (30˚C)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (30˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Warm levobupivacaine at (37˚C)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (37˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine</intervention_name>
    <description>Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)</description>
    <arm_group_label>Warm levobupivacaine at (30˚C)</arm_group_label>
    <arm_group_label>Warm levobupivacaine at (37˚C)</arm_group_label>
    <arm_group_label>levobupivacaine at ( 23˚C)</arm_group_label>
    <other_name>Chirocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA-I or II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient refusal; Any known hypersensitivity or contraindication to levobupivacaine&#xD;
             pregnancy bleeding disorders local skin infections. Sepsis at the site of injection&#xD;
             Coagulation abnormality Psychiatric disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reem El sharkawy</last_name>
    <role>Principal Investigator</role>
    <affiliation>lecturer of anesthesia and surgical intensive care ,faculty of medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adham Elgeidi</last_name>
    <phone>01061057973</phone>
    <email>elgeidi@doctors.org.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Medhat Messeha</last_name>
    <phone>01207788199</phone>
    <email>medhatmikha70@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Adham Elgeidi</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahliah</state>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University Hospital</investigator_affiliation>
    <investigator_full_name>Abdelraouf Elsharkawy</investigator_full_name>
    <investigator_title>Lecturer of anesthesia and surgical intensive care</investigator_title>
  </responsible_party>
  <keyword>levobupivacaine,spinal anesthesia ,temperature</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03790163
org study id: MFM.IRB,R/18.11.340
nct id: NCT03790163
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to evaluate the effect of different temperature on the spinal
      anesthesia characteristics and incidence of complications
Regional anesthesia techniques are also superior to systemic opioids agents with regard the
      analgesic profile and adverse effects .Spinal anesthesia is the most commonly used technique
      due to its unmatchable reliability,simplicity and cost-effectiveness. It provides a fast and
      effective onset of sensory and motor block, excellent muscle relaxation and prolonged
      postoperative analgesia .

      Bupivacaine is commonly used local anesthetics because of its long duration of action and
      combined motor and sensory blockade. However, it has many drawbacks .It has a high propensity
      to cause hypotension and bradycardia. There is also cardiac toxicity.Levobupivacaine is an
      attractive alternative to bupivacaine because of the lower affinity for cardiac sodium
      channels and reducing the risk of cardiac toxicity.Moreover ,the isobaric levobupivacaine had
      more stability in cerebrospinal fluid and thus lead to more predictable drug spread,
      decreasing the incidence of hypotension and bradycardia. But its main disadvantage is the
      delayed onset .

      A number of strategies have been used to hasten the onset of local anesthesia .The addition
      of fentanyl mixtures of local anesthetics and alkalization of the local anesthetics all
      shorten the onset time of sensory block. Recently the warming of the anesthetic agents
      (namely, lidocaine and bupivacaine) to 37° C hastens the sensory block in various surgical
      settings .

      Up till now there is no study suggestive of any appropriate degree of temperature as adjuvant
      .Hence the present study will be conducted to evaluate the effect of different temperature on
      spinal anesthesia characteristics and the incidence its complication
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
masking description: Double(participant ,care provider)
measure: Time to onset of sensory block
time frame: For 10 minutes following the spinal anesthesia
description: Defined as the time interval between the end of spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1)
measure: Time to the onset of motor block
time frame: For 10 minutes following the injection of spinal anesthesia
description: Defined as the time interval between the end of spinal anesthesia and (motor score=1) within both lower limbs
measure: Duration of sensory block
time frame: For 24 hours after the spinal anesthesia
description: Defined as the interval between the end of spinal anesthesia and complete end of sensory block (sensory score=2)
measure: Duration of motor block
time frame: For 24 hours after the spinal anesthesia
description: Defined as the interval between the end of spinal anesthesia and complete recovery of normal motor function (score=0)
measure: Post spinal shivering
time frame: for 24 hours after spinal anesthesia
description: Post spinal shivering will be graded using a scale ( score 0=no shivering ,score 1= no visible muscle activity ,but one or more of piloerection, score 2=muscular activity in only one muscle group,score 3=moderate muscular activity in more than one muscle group but not generalized shaking ,score 4=violent muscular activity that involves entire body )
arm group label: levobupivacaine at ( 23˚C)
arm group type: Placebo Comparator
description: Levobupivacine hydrochloride at ( 23˚C) will be received 3.5 ml levobupivacaine at the operating room temperature 23˚C will be administered
arm group label: Warm levobupivacaine at (30˚C)
arm group type: Active Comparator
description: Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (30˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia
arm group label: Warm levobupivacaine at (37˚C)
arm group type: Active Comparator
description: Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (37˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia
intervention type: Drug
intervention name: Levobupivacaine
description: Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)
arm group label: Warm levobupivacaine at (30˚C)
arm group label: Warm levobupivacaine at (37˚C)
arm group label: levobupivacaine at ( 23˚C)
other name: Chirocaine
criteria: 
gender: All
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Reem El sharkawy
role: Principal Investigator
affiliation: lecturer of anesthesia and surgical intensive care ,faculty of medicine
last name: Adham Elgeidi
phone: 01061057973
email: elgeidi@doctors.org.uk
last name: Medhat Messeha
phone: 01207788199
email: medhatmikha70@yahoo.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University Hospital
investigator full name: Abdelraouf Elsharkawy
investigator title: Lecturer of anesthesia and surgical intensive care
mesh term: Levobupivacaine