<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/NCT03005171</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008718/1438</org_study_id>
    <nct_id>NCT03005171</nct_id>
  </id_info>
  <brief_title>Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery</brief_title>
  <official_title>Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in&#xD;
      patients undergoing open upper abdominal surgery; when compared with thoracic epidural&#xD;
      analgesia. Half of participants will receive intravenous lidocaine infusion, while the other&#xD;
      half will receive thoracic epidural bupivacaine infusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain is one of the commonest problems encountered by anaesthesiologists,&#xD;
      especially after open abdominal surgeries, in which post-operative pain would cause a&#xD;
      restrictive respiratory dysfunction, which is associated with poor postoperative outcomes.&#xD;
      Despite the fact that epidural blocks provide superior analgesia; it is not often an ideal&#xD;
      option as it frequently causes hypotension that may require excessive intravenous fluid&#xD;
      administration, which is particularly deleterious after bowel surgery. Other complications&#xD;
      include epidural hematoma and higher failure rate. Furthermore epidural analgesia may be&#xD;
      contraindicated in some patients e.g. patients on certain anti-platelet therapy and patients&#xD;
      refusing the technique.&#xD;
&#xD;
      Other modalities to control postoperative pain are used e.g. intravenous analgesics and&#xD;
      continuous wound infiltration, but none of which was proven to be as effective as epidural&#xD;
      block.&#xD;
&#xD;
      Whether perioperative lidocaine infusion is as effective as epidural block in reducing&#xD;
      post-operative pain, is this study's concern.&#xD;
&#xD;
      Some researches studied the efficacy of lidocaine infusion in controlling neuropathic as well&#xD;
      as acute postoperative pain with encouraging results. Lidocaine infusion was found to reduce&#xD;
      postoperative pain, opioid consumption and the length of hospital stay. Although risks of&#xD;
      neurological and cardiac toxicity exist, these were not substantiated in the trials.&#xD;
&#xD;
      Lidocaine has been described to have both analgesic, and anti-hyperalgesic effects6, as well&#xD;
      as anti-inflammatory properties. It also accelerates the return of post-operative&#xD;
      gastrointestinal function, which is of particular importance after major abdominal surgery.&#xD;
      Opposite to opioids, which increase the incidence of nausea and vomiting, lidocaine decreases&#xD;
      their incidence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Verbal Numeric Rating Score</measure>
    <time_frame>2-24 hours</time_frame>
    <description>Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>B- endorphin level</measure>
    <time_frame>Baseline-24 hours</time_frame>
    <description>A measure for postoperative pain response compared to the baseline values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FVC</measure>
    <time_frame>Baseline-24 hours</time_frame>
    <description>Forced Vital Capacity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1</measure>
    <time_frame>Baseline-24 hours</time_frame>
    <description>Forced Expiratory Volume</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>Epidural</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused.&#xD;
The infusion continues for 24h</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lidocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min.&#xD;
The infusion continues for 24h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Thoracic epidural bupivacaine infusion</description>
    <arm_group_label>Epidural</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Intravenous lidocaine infusion</description>
    <arm_group_label>Lidocaine</arm_group_label>
    <other_name>Xylocaine</other_name>
    <other_name>Lidocaine Hydrochloride</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing open upper abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bleeding diathesis&#xD;
&#xD;
          -  History of allergy to local anesthetics&#xD;
&#xD;
          -  Pregnancy/ lactation&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Respiratory disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Assiut University</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University, Egypt</affiliation>
  </overall_official>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>December 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 6, 2017</last_update_submitted>
  <last_update_submitted_qc>December 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Asmaa Mohamed Moatasem</investigator_full_name>
    <investigator_title>Assistant Lecturer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03005171
org study id: IRB00008718/1438
nct id: NCT03005171
lead sponsor: 
has dmc: Yes
The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in
      patients undergoing open upper abdominal surgery; when compared with thoracic epidural
      analgesia. Half of participants will receive intravenous lidocaine infusion, while the other
      half will receive thoracic epidural bupivacaine infusion.
Postoperative pain is one of the commonest problems encountered by anaesthesiologists,
      especially after open abdominal surgeries, in which post-operative pain would cause a
      restrictive respiratory dysfunction, which is associated with poor postoperative outcomes.
      Despite the fact that epidural blocks provide superior analgesia; it is not often an ideal
      option as it frequently causes hypotension that may require excessive intravenous fluid
      administration, which is particularly deleterious after bowel surgery. Other complications
      include epidural hematoma and higher failure rate. Furthermore epidural analgesia may be
      contraindicated in some patients e.g. patients on certain anti-platelet therapy and patients
      refusing the technique.

      Other modalities to control postoperative pain are used e.g. intravenous analgesics and
      continuous wound infiltration, but none of which was proven to be as effective as epidural
      block.

      Whether perioperative lidocaine infusion is as effective as epidural block in reducing
      post-operative pain, is this study's concern.

      Some researches studied the efficacy of lidocaine infusion in controlling neuropathic as well
      as acute postoperative pain with encouraging results. Lidocaine infusion was found to reduce
      postoperative pain, opioid consumption and the length of hospital stay. Although risks of
      neurological and cardiac toxicity exist, these were not substantiated in the trials.

      Lidocaine has been described to have both analgesic, and anti-hyperalgesic effects6, as well
      as anti-inflammatory properties. It also accelerates the return of post-operative
      gastrointestinal function, which is of particular importance after major abdominal surgery.
      Opposite to opioids, which increase the incidence of nausea and vomiting, lidocaine decreases
      their incidence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Verbal Numeric Rating Score
time frame: 2-24 hours
description: Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants
measure: B- endorphin level
time frame: Baseline-24 hours
description: A measure for postoperative pain response compared to the baseline values
measure: FVC
time frame: Baseline-24 hours
description: Forced Vital Capacity
measure: FEV1
time frame: Baseline-24 hours
description: Forced Expiratory Volume
arm group label: Epidural
arm group type: Active Comparator
description: Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused.
The infusion continues for 24h
arm group label: Lidocaine
arm group type: Active Comparator
description: Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min.
The infusion continues for 24h
intervention type: Drug
intervention name: Bupivacaine
description: Thoracic epidural bupivacaine infusion
arm group label: Epidural
other name: Marcaine
intervention type: Drug
intervention name: Lidocaine
description: Intravenous lidocaine infusion
arm group label: Lidocaine
other name: Xylocaine
other name: Lidocaine Hydrochloride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Assiut University
role: Study Director
affiliation: Assiut University, Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Asmaa Mohamed Moatasem
investigator title: Assistant Lecturer
mesh term: Acute Pain
mesh term: Lidocaine
mesh term: Bupivacaine
sharing ipd: Undecided