<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/NCT01699919</url>
  </required_header>
  <id_info>
    <org_study_id>IEC No. : EC/2011/2/24</org_study_id>
    <nct_id>NCT01699919</nct_id>
  </id_info>
  <brief_title>A Study to Assess Analgesic Efficacy of Intravenous Lignocaine</brief_title>
  <official_title>Effect of Perioperative Systemic Lignocaine on Postoperative Pain in Patients Undergoing Elective Open Abdominal Surgeries- a Double Blinded Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jawaharlal Institute of Postgraduate Medical Education &amp; Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jawaharlal Institute of Postgraduate Medical Education &amp; Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are to analyse the effect of perioperative systemic&#xD;
      infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and&#xD;
      perioperative levels of inflammatory mediators in patients undergoing elective open abdominal&#xD;
      surgeries.&#xD;
&#xD;
      The secondary parameters which will be observed during the study are the time to passage of&#xD;
      flatus and stools postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized into two groups- A and B, to receive an intravenous infusion of&#xD;
      lignocaine or saline,respectively, as a bolus of 1.5mg/kg at the time of intubation followed&#xD;
      by an infusion at a rate of 1.5mg/kg/hr continued throughout the surgery and till one hour&#xD;
      postop. Postoperative analgesia will be provided through Patient Controlled Analgesia (PCA)&#xD;
      pump providing morphine. Postoperative pain scores will be noted at immediate postoperative&#xD;
      and at 6, 18, 24 hours post surgery. The number of PCA demands and cumulative morphine&#xD;
      consumption till 24 hours post surgery will be noted. The incidence of postoperative nausea&#xD;
      and vomiting is recorded. The time to first passage of flatus and stools postoperatively will&#xD;
      be noted. Levels of total leukocyte count, c-reactive protein (CRP) and interleukin-6(IL-6)&#xD;
      will be noted in preoperative, immediate post operative and 24 hours post surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain scores using visual analogue scale</measure>
    <time_frame>till 24 hours post surgery</time_frame>
    <description>Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patient controlled analgesia demands</measure>
    <time_frame>Till 24 hours post surgery</time_frame>
    <description>The total number of times the patient presses the demand button of PCA pump are noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total amount of morphine consumed</measure>
    <time_frame>till 24 hours post surgery</time_frame>
    <description>The total morphine consumption till 24 hours post surgery is noted.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perioperative levels of inflammatory mediators</measure>
    <time_frame>in preoperative period, immediate post op and 24 hours post surgery</time_frame>
    <description>Blood samples will be collected for the analysis of total leukocyte count, C-reactive protein and Interleukin-6 levels in the preoperative period, immediate postoperative and at 24 hours post surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>time of passage of flatus and stools postoperatively</measure>
    <time_frame>till postoperative day 7</time_frame>
    <description>Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Postoperative Ileus</condition>
  <arm_group>
    <arm_group_label>intravenous lignocaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous lignocaine will be given as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr throughout surgery and till one hour post surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline will be given as a bolus at the time of intubation and saline infusion given to patients in the control group during the surgery and till one hour post surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous lignocaine</intervention_name>
    <description>Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.</description>
    <arm_group_label>intravenous lignocaine</arm_group_label>
    <arm_group_label>normal saline</arm_group_label>
    <other_name>Lidocaine, Xylocard</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients above 18 years of age&#xD;
&#xD;
          -  undergoing elective open abdominal surgeries&#xD;
&#xD;
          -  belonging to the American Society of Anaesthesiologists (ASA)status I,II,III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients sensitive to lignocaine,&#xD;
&#xD;
          -  patients suffering from cardiovascular diseases or with preoperative changes on&#xD;
             electrocardiogram&#xD;
&#xD;
          -  patients on beta blocker drugs&#xD;
&#xD;
          -  patients on opioid drugs for prolonged period&#xD;
&#xD;
          -  patients with functional bowel disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>parnandi sridhar, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jawaharlal Institute of Postgraduate Medical Education and Research</name>
      <address>
        <city>Puducherry</city>
        <zip>605006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.</citation>
    <PMID>3898920</PMID>
  </reference>
  <reference>
    <citation>Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.</citation>
    <PMID>9459225</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jawaharlal Institute of Postgraduate Medical Education &amp; Research</investigator_affiliation>
    <investigator_full_name>Dr.P.Sridhar</investigator_full_name>
    <investigator_title>Junior resident, Department of Surgery, Principal investigator</investigator_title>
  </responsible_party>
  <keyword>perioperative lignocaine infusion</keyword>
  <keyword>elective open abdominal surgeries</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</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/NCT01699919
org study id: IEC No. : EC/2011/2/24
nct id: NCT01699919
lead sponsor: 
has dmc: No
The primary objectives of this study are to analyse the effect of perioperative systemic
      infusion of lignocaine on postoperative pain, postoperative nausea and vomiting and
      perioperative levels of inflammatory mediators in patients undergoing elective open abdominal
      surgeries.

      The secondary parameters which will be observed during the study are the time to passage of
      flatus and stools postoperatively.
Patients will be randomized into two groups- A and B, to receive an intravenous infusion of
      lignocaine or saline,respectively, as a bolus of 1.5mg/kg at the time of intubation followed
      by an infusion at a rate of 1.5mg/kg/hr continued throughout the surgery and till one hour
      postop. Postoperative analgesia will be provided through Patient Controlled Analgesia (PCA)
      pump providing morphine. Postoperative pain scores will be noted at immediate postoperative
      and at 6, 18, 24 hours post surgery. The number of PCA demands and cumulative morphine
      consumption till 24 hours post surgery will be noted. The incidence of postoperative nausea
      and vomiting is recorded. The time to first passage of flatus and stools postoperatively will
      be noted. Levels of total leukocyte count, c-reactive protein (CRP) and interleukin-6(IL-6)
      will be noted in preoperative, immediate post operative and 24 hours post surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: postoperative pain scores using visual analogue scale
time frame: till 24 hours post surgery
description: Postoperative pain scores are assessed in the patients using a visual analogue scale in the first 24 hours post surgery
measure: Number of patient controlled analgesia demands
time frame: Till 24 hours post surgery
description: The total number of times the patient presses the demand button of PCA pump are noted.
measure: Total amount of morphine consumed
time frame: till 24 hours post surgery
description: The total morphine consumption till 24 hours post surgery is noted.
measure: Perioperative levels of inflammatory mediators
time frame: in preoperative period, immediate post op and 24 hours post surgery
description: Blood samples will be collected for the analysis of total leukocyte count, C-reactive protein and Interleukin-6 levels in the preoperative period, immediate postoperative and at 24 hours post surgery.
measure: time of passage of flatus and stools postoperatively
time frame: till postoperative day 7
description: Postoperative bowel function recovery will be assessed by noting the time of first passage of flatus and stools postoperatively
arm group label: intravenous lignocaine
arm group type: Active Comparator
description: Intravenous lignocaine will be given as a bolus of 1.5mg/kg at the time of intubation followed by an infusion at a rate of 1.5mg/kg/hr throughout surgery and till one hour post surgery.
arm group label: normal saline
arm group type: Placebo Comparator
description: Normal saline will be given as a bolus at the time of intubation and saline infusion given to patients in the control group during the surgery and till one hour post surgery.
intervention type: Drug
intervention name: Intravenous lignocaine
description: Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.
arm group label: intravenous lignocaine
arm group label: normal saline
other name: Lidocaine, Xylocard
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: parnandi sridhar, MBBS
role: Principal Investigator
affiliation: Junior resident,JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH, PUDUCHERRY, INDIA
facility: 
country: India
citation: Cassuto J, Wallin G, Hogstrom S, Faxen A, Rimback G. Inhibition of postoperative pain by continuous low-dose intravenous infusion of lidocaine. Anesth Analg. 1985 Oct;64(10):971-4.
PMID: 3898920
citation: Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
PMID: 9459225
responsible party type: Principal Investigator
investigator affiliation: Jawaharlal Institute of Postgraduate Medical Education & Research
investigator full name: Dr.P.Sridhar
investigator title: Junior resident, Department of Surgery, Principal investigator
mesh term: Pain, Postoperative
mesh term: Vomiting
mesh term: Postoperative Nausea and Vomiting
mesh term: Lidocaine