<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/NCT02997215</url>
  </required_header>
  <id_info>
    <org_study_id>2015-YJJ-GGL-008</org_study_id>
    <nct_id>NCT02997215</nct_id>
  </id_info>
  <brief_title>Intravenous Lidocaine and Postoperative Pain Management</brief_title>
  <official_title>Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tongren Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was to evaluate the effect of intraoperative intravenous lidocaine on&#xD;
      postoperative pain management after laparoscopic cholecystectomy. Half of patients will&#xD;
      receive intravenous lidocaine during procedure, the rest half of patients will receive&#xD;
      regular anesthesia care and placebo treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pain and ileus are primary reasons for delayed patient recovery and longer&#xD;
      hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this&#xD;
      patient population. However, opioid administration can exacerbate postoperative ileus and&#xD;
      further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore&#xD;
      recommended for pain control after abdominal surgery to reduce opioid consumption and&#xD;
      opioid-related adverse effects.&#xD;
&#xD;
      Studies have reported that systemically administered lidocaine has analgesic,&#xD;
      anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published&#xD;
      that evaluated systemically administered lidocaine for postoperative pain management and&#xD;
      recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine&#xD;
      for postoperative recovery remains controversial. Therefore, the investigators performed this&#xD;
      study to evaluate the efficacy of systemic administration of lidocaine for postoperative&#xD;
      analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators&#xD;
      primary hypothesis is that systemic lidocaine administration reduces pain intensity following&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain score</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>visual analogue score (1-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative pain score</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>visual analogue score (1-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative pain score</measure>
    <time_frame>72 hours after surgery</time_frame>
    <description>visual analogue score (1-10)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total postoperative opioid consumption</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>postoperative fentanyl consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of postoperative complication</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>opioid-related side effects, such as nausea and vomiting, and the incidence of adverse effects associated with systemic administration of lidocaine.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Postoperative Pain Management</condition>
  <arm_group>
    <arm_group_label>intravenous lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>saline placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>same amount volume saline infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>lidocaine infusion during surgery</description>
    <arm_group_label>intravenous lidocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Placebo</intervention_name>
    <description>saline infusion at same rate as intervention group during surgery</description>
    <arm_group_label>saline placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist (ASA) status I-II adult patients undergoing&#xD;
             elective laparoscopic cholecystectomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Open surgery;&#xD;
&#xD;
          -  Patients allergic to lidocaine or other local anesthetics;&#xD;
&#xD;
          -  Drug abuser.&#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>Department of Anesthesiology; Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CHUXIONG PAN</last_name>
      <phone>8613811760025</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 16, 2016</last_update_submitted>
  <last_update_submitted_qc>December 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tongren Hospital</investigator_affiliation>
    <investigator_full_name>YANXIA SUN</investigator_full_name>
    <investigator_title>Vice-Chief Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>intravenous lidocaine</keyword>
  <keyword>postoperative pain management</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>De-identified individual participants data for primary and secondary outcome measures will be available within 6 months of study completion</ipd_description>
  </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/NCT02997215
org study id: 2015-YJJ-GGL-008
nct id: NCT02997215
lead sponsor: 
has dmc: Yes
This study was to evaluate the effect of intraoperative intravenous lidocaine on
      postoperative pain management after laparoscopic cholecystectomy. Half of patients will
      receive intravenous lidocaine during procedure, the rest half of patients will receive
      regular anesthesia care and placebo treatment.
Postoperative pain and ileus are primary reasons for delayed patient recovery and longer
      hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this
      patient population. However, opioid administration can exacerbate postoperative ileus and
      further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore
      recommended for pain control after abdominal surgery to reduce opioid consumption and
      opioid-related adverse effects.

      Studies have reported that systemically administered lidocaine has analgesic,
      anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published
      that evaluated systemically administered lidocaine for postoperative pain management and
      recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine
      for postoperative recovery remains controversial. Therefore, the investigators performed this
      study to evaluate the efficacy of systemic administration of lidocaine for postoperative
      analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators
      primary hypothesis is that systemic lidocaine administration reduces pain intensity following
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: postoperative pain score
time frame: 6 hours after surgery
description: visual analogue score (1-10)
measure: postoperative pain score
time frame: 24 hours after surgery
description: visual analogue score (1-10)
measure: postoperative pain score
time frame: 72 hours after surgery
description: visual analogue score (1-10)
measure: total postoperative opioid consumption
time frame: 48 hours after surgery
description: postoperative fentanyl consumption
measure: incidence of postoperative complication
time frame: 48 hours after surgery
description: opioid-related side effects, such as nausea and vomiting, and the incidence of adverse effects associated with systemic administration of lidocaine.
arm group label: intravenous lidocaine
arm group type: Experimental
description: intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure.
arm group label: saline placebo
arm group type: Placebo Comparator
description: same amount volume saline infusion
intervention type: Drug
intervention name: Lidocaine
description: lidocaine infusion during surgery
arm group label: intravenous lidocaine
intervention type: Drug
intervention name: Saline Placebo
description: saline infusion at same rate as intervention group during surgery
arm group label: saline placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Tongren Hospital
investigator full name: YANXIA SUN
investigator title: Vice-Chief Anesthesiologist
mesh term: Pain, Postoperative
mesh term: Lidocaine
sharing ipd: Yes
ipd description: De-identified individual participants data for primary and secondary outcome measures will be available within 6 months of study completion