<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/NCT04480281</url>
  </required_header>
  <id_info>
    <org_study_id>CEHDF 972</org_study_id>
    <nct_id>NCT04480281</nct_id>
  </id_info>
  <brief_title>Intravenous Lidocaine in Open Lung Resection Surgery</brief_title>
  <official_title>Intravenous Lidocaine Reduces Pain Scores and Opioid Consumption in Open Lung Resection Surgery: A Prospective Randomized Double-Blind Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saint-Joseph University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saint-Joseph University</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>
      Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the&#xD;
      perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest&#xD;
      adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and&#xD;
      anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in&#xD;
      colorectal surgery.&#xD;
&#xD;
      However, no study has evaluated the effect of a continuous lidocaine infusion for open lung&#xD;
      resection in the post-operative period. The present study aims to evaluate the influence of&#xD;
      IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and&#xD;
      possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2020</start_date>
  <completion_date type="Actual">May 15, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption in the post operative period</measure>
    <time_frame>Doses were measured for twenty four hours in the post operative period</time_frame>
    <description>Total dose of morphine in the post operative period is measured for patients in both arms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain scores at rest and at cough</measure>
    <time_frame>Measurements were made for 24 hours in the post operative period</time_frame>
    <description>Analogue visual scale ( a 10cm scale , zero representing no pain and 10 representing the worst imaginable pain)) was used to measure pain scores for each patient at rest and at cough</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary complications</measure>
    <time_frame>Measurements were recorded for 24 hours in the post operative period</time_frame>
    <description>Arterial partial carbon dioxide pressure (PCO2) measurements were recorded for patients in both arms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Lidocaine</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Lidocaine Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine Iv</intervention_name>
    <description>Patients in the Lidocaine group received a bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery</description>
    <arm_group_label>Lidocaine Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>Patients in Group Placebo received an equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American society of anesthesiologists (ASA) scores of I, II or III.&#xD;
&#xD;
          -  Left or right posterolateral thoracotomy with postoperative monitoring in the&#xD;
             intensive care unit (ICU) for at least 24 hours (h).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient's refusal to participate&#xD;
&#xD;
          -  ASA score of IV or higher&#xD;
&#xD;
          -  severe hepatic or renal insufficiency&#xD;
&#xD;
          -  allergy to lidocaine, morphine or NSAIDs&#xD;
&#xD;
          -  cardiac arrhythmias or&#xD;
&#xD;
          -  epilepsy,&#xD;
&#xD;
          -  delayed extubation for more than 2 h postoperatively&#xD;
&#xD;
          -  urgent surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hotel Dieu de France</name>
      <address>
        <city>Beirut</city>
        <zip>1104 2020</zip>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <reference>
    <citation>Swenson BR, Gottschalk A, Wells LT, Rowlingson JC, Thompson PW, Barclay M, Sawyer RG, Friel CM, Foley E, Durieux ME. Intravenous lidocaine is as effective as epidural bupivacaine in reducing ileus duration, hospital stay, and pain after open colon resection: a randomized clinical trial. Reg Anesth Pain Med. 2010 Jul-Aug;35(4):370-6. doi: 10.1097/AAP.0b013e3181e8d5da.</citation>
    <PMID>20588151</PMID>
  </reference>
  <results_reference>
    <citation>Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.</citation>
    <PMID>19478674</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saint-Joseph University</investigator_affiliation>
    <investigator_full_name>Afrida Gergess</investigator_full_name>
    <investigator_title>Anesthesiologist specialized in cardiovascular and thoracic surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04480281
org study id: CEHDF 972
nct id: NCT04480281
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Management of postoperative pain in 2020 remains a challenge for anesthesiologists in the
      perioperative period. Lidocaine is an amide local anesthetic, it is one of the oldest
      adjuvant analgesics and is known to possess analgesic, anti-hyperalgesic and
      anti-inflammatory properties. Lidocaine is proven to be as effective as epidural analgesia in
      colorectal surgery.

      However, no study has evaluated the effect of a continuous lidocaine infusion for open lung
      resection in the post-operative period. The present study aims to evaluate the influence of
      IV lidocaine given during and 24 hours after surgery, on pain scores, opioid consumption, and
      possible benefits on patient outcome via the opioid-sparing effect in open thoracic surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Opioid consumption in the post operative period
time frame: Doses were measured for twenty four hours in the post operative period
description: Total dose of morphine in the post operative period is measured for patients in both arms
measure: Pain scores at rest and at cough
time frame: Measurements were made for 24 hours in the post operative period
description: Analogue visual scale ( a 10cm scale , zero representing no pain and 10 representing the worst imaginable pain)) was used to measure pain scores for each patient at rest and at cough
measure: Pulmonary complications
time frame: Measurements were recorded for 24 hours in the post operative period
description: Arterial partial carbon dioxide pressure (PCO2) measurements were recorded for patients in both arms
arm group label: Lidocaine Group
arm group type: Active Comparator
description: Bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively
intervention type: Drug
intervention name: Lidocaine Iv
description: Patients in the Lidocaine group received a bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery
arm group label: Lidocaine Group
intervention type: Drug
intervention name: Normal Saline
description: Patients in Group Placebo received an equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Lebanon
citation: Swenson BR, Gottschalk A, Wells LT, Rowlingson JC, Thompson PW, Barclay M, Sawyer RG, Friel CM, Foley E, Durieux ME. Intravenous lidocaine is as effective as epidural bupivacaine in reducing ileus duration, hospital stay, and pain after open colon resection: a randomized clinical trial. Reg Anesth Pain Med. 2010 Jul-Aug;35(4):370-6. doi: 10.1097/AAP.0b013e3181e8d5da.
PMID: 20588151
citation: Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.
PMID: 19478674
responsible party type: Principal Investigator
investigator affiliation: Saint-Joseph University
investigator full name: Afrida Gergess
investigator title: Anesthesiologist specialized in cardiovascular and thoracic surgery
mesh term: Pain, Postoperative
mesh term: Lidocaine
sharing ipd: No