<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/NCT01675895</url>
  </required_header>
  <id_info>
    <org_study_id>DİLEKLEVOBUPİVACAİNE</org_study_id>
    <nct_id>NCT01675895</nct_id>
  </id_info>
  <brief_title>Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration</brief_title>
  <official_title>Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Teaching and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Teaching and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective was to test the hypothesis that adding lidocaine to hyperbaric&#xD;
      levobupivacaine could change the duration of levobupivacaine spinal block.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same&#xD;
      time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The&#xD;
      addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal&#xD;
      block and therefore provides more rapid recovery. This property of lidocaine is not verified&#xD;
      with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is&#xD;
      a long acting local anesthetic.The aim of this prospective randomized controlled study was to&#xD;
      investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was&#xD;
      hypothesized that the duration of the intrathecal block could change when performed with&#xD;
      hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be&#xD;
      consistent for the duration of TUR-P surgery. Participants will be followed on the day of&#xD;
      surgery for primary and secondary outcome measures and 3 days postoperatively for&#xD;
      complications (TNS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2009</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</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>The duration of the spinal block (S1 regression of the block)</measure>
    <time_frame>participanta will be followed on the operation day</time_frame>
    <description>the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative care unit stay</measure>
    <time_frame>participants will be followed on the operation day</time_frame>
    <description>the time between the patient entered the PACU and left the PACU (when the sensorial block was regressed to S1 dermatome and the patient fulfilled an Aldrete score higher or equal to 9), measured in minutes</description>
  </secondary_outcome>
  <other_outcome>
    <measure>maximum block level</measure>
    <time_frame>participants will be followed on the operation day</time_frame>
    <description>the dermatomal level that the sensorial block reached, determined with the pin prick test, expressed with dermatomes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Benign Prostate Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Group Levobupivacaine lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine lidocaine spinal anesthesia</intervention_name>
    <description>Spinal anesthesia</description>
    <arm_group_label>Group Levobupivacaine lidocaine</arm_group_label>
    <other_name>Chirocaine</other_name>
    <other_name>Lidocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>levobupivacaine Spinal anesthesia</intervention_name>
    <description>spinal anesthesia</description>
    <arm_group_label>Group Control</arm_group_label>
    <other_name>Chirocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective transurethral resection of the prostate (TUR-P)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with contraindications for spinal anesthesia,&#xD;
&#xD;
          -  known sensitivity to the study drugs,&#xD;
&#xD;
          -  emergency cases, and&#xD;
&#xD;
          -  patients who refused spinal anaesthesia were excluded&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Taylan Akkaya, MD</last_name>
    <role>Study Director</role>
    <affiliation>Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.</citation>
    <PMID>18713891</PMID>
  </reference>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>December 17, 2012</last_update_submitted>
  <last_update_submitted_qc>December 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Teaching and Research Hospital</investigator_affiliation>
    <investigator_full_name>DILEK YAZICIOGLU</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Hyperbaric Levobupivacaine</keyword>
  <keyword>İntrathecal</keyword>
  <keyword>Lidocaine</keyword>
  <keyword>TUR-P</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
    <mesh_term>Anesthetics</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/NCT01675895
org study id: DİLEKLEVOBUPİVACAİNE
nct id: NCT01675895
lead sponsor: 
has dmc: No
The main objective was to test the hypothesis that adding lidocaine to hyperbaric
      levobupivacaine could change the duration of levobupivacaine spinal block.
A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same
      time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The
      addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal
      block and therefore provides more rapid recovery. This property of lidocaine is not verified
      with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is
      a long acting local anesthetic.The aim of this prospective randomized controlled study was to
      investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was
      hypothesized that the duration of the intrathecal block could change when performed with
      hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be
      consistent for the duration of TUR-P surgery. Participants will be followed on the day of
      surgery for primary and secondary outcome measures and 3 days postoperatively for
      complications (TNS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The duration of the spinal block (S1 regression of the block)
time frame: participanta will be followed on the operation day
description: the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes
measure: postoperative care unit stay
time frame: participants will be followed on the operation day
description: the time between the patient entered the PACU and left the PACU (when the sensorial block was regressed to S1 dermatome and the patient fulfilled an Aldrete score higher or equal to 9), measured in minutes
measure: maximum block level
time frame: participants will be followed on the operation day
description: the dermatomal level that the sensorial block reached, determined with the pin prick test, expressed with dermatomes
arm group label: Group Levobupivacaine lidocaine
arm group type: Experimental
description: Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine
arm group label: Group Control
arm group type: Active Comparator
description: Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline
intervention type: Drug
intervention name: Levobupivacaine lidocaine spinal anesthesia
description: Spinal anesthesia
arm group label: Group Levobupivacaine lidocaine
other name: Chirocaine
other name: Lidocaine
intervention type: Drug
intervention name: levobupivacaine Spinal anesthesia
description: spinal anesthesia
arm group label: Group Control
other name: Chirocaine
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Taylan Akkaya, MD
role: Study Director
affiliation: Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
facility: 
country: Turkey
citation: Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.
PMID: 18713891
responsible party type: Principal Investigator
investigator affiliation: Diskapi Teaching and Research Hospital
investigator full name: DILEK YAZICIOGLU
investigator title: Principal investigator
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Lidocaine
mesh term: Levobupivacaine
mesh term: Anesthetics