<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/NCT01717222</url>
  </required_header>
  <id_info>
    <org_study_id>SEC/2011/4/109</org_study_id>
    <nct_id>NCT01717222</nct_id>
  </id_info>
  <brief_title>Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy</brief_title>
  <official_title>Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy - A Randomized Clinical 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall&#xD;
      stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and&#xD;
      intravenous administration of lignocaine has been used. But it is not clear from the existing&#xD;
      literature which form of administration is more effective for pain relief. Hence this study&#xD;
      has been undertaken with the following hypothesis : Intravenous lignocaine is superior to&#xD;
      intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response&#xD;
      in laparoscopic cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall&#xD;
      stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and&#xD;
      intravenous administration of lignocaine has been used. But it is not clear from the existing&#xD;
      literature which form of administration is more effective for pain relief. Hence this study&#xD;
      has been undertaken with the following hypothesis : Intravenous lignocaine is superior to&#xD;
      intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response&#xD;
      in laparoscopic cholecystectomy.&#xD;
&#xD;
      In this study the effect of intraperitoneal and intravenous lignocaine will be assessed based&#xD;
      on the postoperative pain scores, total analgesic requirement, stress response in the form of&#xD;
      total leukocyte count, c-reactive protein levels,return of bowel activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative pain relief</measure>
    <time_frame>1 hour postoperatively</time_frame>
    <description>Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 1 hour postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Analgesic Requirement</measure>
    <time_frame>First 24 hours in the postoperative period</time_frame>
    <description>Patients will get analgesia through patient controlled analgesia pump (PCA). This pump delivers Morphine for pain relief. This will be delivered at 1 mg/ml bolus dose with a lock out period of 15 minutes without any background infusion of the drug. The total requirement over a period of 24 hours will be noted. Also the time taken for the patient to take the first analgesic dose will be recorded. The total demands and the number of good demands in the PCA pump will also be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain relief</measure>
    <time_frame>8 hours postoperatively</time_frame>
    <description>Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 8 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain relief</measure>
    <time_frame>24 hours postoperatively</time_frame>
    <description>Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 24 hours postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain relief</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 48 hours postoperatively</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP)</measure>
    <time_frame>Preoperatively and 48 hours Postoperatively</time_frame>
    <description>Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response</description>
  </other_outcome>
  <other_outcome>
    <measure>Respiratory Function</measure>
    <time_frame>Preoperatively and 48 hours Postoperatively</time_frame>
    <description>Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames.</description>
  </other_outcome>
  <other_outcome>
    <measure>Return of bowel activity</measure>
    <time_frame>upto to 48 hours</time_frame>
    <description>This will be assessed by asking the time at which the patient perceives the first bowel movement and also the time for passage of flatus post surgery.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Analgesic Requirement</condition>
  <condition>Stress Response</condition>
  <condition>Return of Bowel Activity</condition>
  <condition>Inadequate or Impaired Respiratory Function</condition>
  <arm_group>
    <arm_group_label>Intraperitoneal (IP) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 100 ml of 0.2% Lignocaine as intraperitoneal lignocaine irrigation in the gall bladder fossa along with a placebo of normal saline of volume equivalent to 1.5 mg/kg of intravenous lignocaine at induction and normal saline of volume equivalent to 2 mg/kg/hour of intravenous lignocaine as continuous infusion until one hour postoperatively to ensure blinding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intravenous (IV) group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive 1.5mg/kg of intravenous lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lignocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intraperitoneal Lignocaine</intervention_name>
    <description>Patients will receive 100 ml of 0.2% lignocaine</description>
    <arm_group_label>Intraperitoneal (IP) group</arm_group_label>
    <other_name>IP Lignocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous Lignocaine</intervention_name>
    <description>Intravenous group patients will receive 1.5mg/kg of lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion until one hour after surgery</description>
    <arm_group_label>Intravenous (IV) group</arm_group_label>
    <other_name>IV lignocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients planned for elective laparoscopic cholecystectomy in the age group of 20 -60&#xD;
             years belonging to American society of anesthesiologists (ASA)score I-II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain diseases other than gall stone disease.&#xD;
&#xD;
          -  Use of opioids, steroids, Non steroidal anti inflammatory drugs or alcohol.&#xD;
&#xD;
          -  Allergy and contraindication to Lignocaine.&#xD;
&#xD;
          -  Conversion to open cholecystectomy.&#xD;
&#xD;
          -  Patients who do not comprehend Visual analogue scale (VAS) / patient controlled&#xD;
             analgesia (PCA).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Sarath Chandra Sistla, M.S.,</last_name>
    <role>Study Chair</role>
    <affiliation>Jawaharlal Institute of Postgraduate Medical Education &amp; Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, JIPMER</name>
      <address>
        <city>Pondicherry</city>
        <zip>605006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov</url>
    <description>Pubmed site</description>
  </link>
  <reference>
    <citation>Jabbour-Khoury SI, Dabbous AS, Gerges FJ, Azar MS, Ayoub CM, Khoury GS. Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy. JSLS. 2005 Jul-Sep;9(3):316-21.</citation>
    <PMID>16121879</PMID>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 29, 2012</last_update_submitted>
  <last_update_submitted_qc>October 29, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 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.D.Ram</investigator_full_name>
    <investigator_title>Junior Resident</investigator_title>
  </responsible_party>
  <keyword>Lignocaine</keyword>
  <keyword>Laparoscopic cholecystectomy</keyword>
  <keyword>Pain relief</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <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>
  <!-- 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/NCT01717222
org study id: SEC/2011/4/109
nct id: NCT01717222
lead sponsor: 
has dmc: Yes
Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall
      stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and
      intravenous administration of lignocaine has been used. But it is not clear from the existing
      literature which form of administration is more effective for pain relief. Hence this study
      has been undertaken with the following hypothesis : Intravenous lignocaine is superior to
      intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response
      in laparoscopic cholecystectomy.
Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall
      stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and
      intravenous administration of lignocaine has been used. But it is not clear from the existing
      literature which form of administration is more effective for pain relief. Hence this study
      has been undertaken with the following hypothesis : Intravenous lignocaine is superior to
      intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response
      in laparoscopic cholecystectomy.

      In this study the effect of intraperitoneal and intravenous lignocaine will be assessed based
      on the postoperative pain scores, total analgesic requirement, stress response in the form of
      total leukocyte count, c-reactive protein levels,return of bowel activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Post operative pain relief
time frame: 1 hour postoperatively
description: Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 1 hour postoperatively.
measure: Postoperative Analgesic Requirement
time frame: First 24 hours in the postoperative period
description: Patients will get analgesia through patient controlled analgesia pump (PCA). This pump delivers Morphine for pain relief. This will be delivered at 1 mg/ml bolus dose with a lock out period of 15 minutes without any background infusion of the drug. The total requirement over a period of 24 hours will be noted. Also the time taken for the patient to take the first analgesic dose will be recorded. The total demands and the number of good demands in the PCA pump will also be recorded.
measure: Postoperative pain relief
time frame: 8 hours postoperatively
description: Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 8 hours postoperatively
measure: Postoperative pain relief
time frame: 24 hours postoperatively
description: Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 24 hours postoperatively
measure: Postoperative pain relief
time frame: 48 hours postoperatively
description: Post operative pain relief will be assessed by visual analogue scale with values between 0 and 10. 0 denotes no pain and 10 denotes worst pain. the patient uses this scale to represent his/her pain at 48 hours postoperatively
measure: Stress response in the form of Total Leucocyte Count (TLC) and C- reactive protein (CRP)
time frame: Preoperatively and 48 hours Postoperatively
description: Blood will be analyzed for TLC and CRP preoperatively and 48 hours postoperatively to assess the stress response
measure: Respiratory Function
time frame: Preoperatively and 48 hours Postoperatively
description: Respiratory function will be assessed by measuring the peak expiratory flow rate (PEFR)at the above mentioned time frames.
measure: Return of bowel activity
time frame: upto to 48 hours
description: This will be assessed by asking the time at which the patient perceives the first bowel movement and also the time for passage of flatus post surgery.
arm group label: Intraperitoneal (IP) group
arm group type: Active Comparator
description: Patients will receive 100 ml of 0.2% Lignocaine as intraperitoneal lignocaine irrigation in the gall bladder fossa along with a placebo of normal saline of volume equivalent to 1.5 mg/kg of intravenous lignocaine at induction and normal saline of volume equivalent to 2 mg/kg/hour of intravenous lignocaine as continuous infusion until one hour postoperatively to ensure blinding
arm group label: Intravenous (IV) group
arm group type: Active Comparator
description: Patients will receive 1.5mg/kg of intravenous lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lignocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding.
intervention type: Drug
intervention name: Intraperitoneal Lignocaine
description: Patients will receive 100 ml of 0.2% lignocaine
arm group label: Intraperitoneal (IP) group
other name: IP Lignocaine
intervention type: Drug
intervention name: Intravenous Lignocaine
description: Intravenous group patients will receive 1.5mg/kg of lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion until one hour after surgery
arm group label: Intravenous (IV) group
other name: IV lignocaine
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Dr. Sarath Chandra Sistla, M.S.,
role: Study Chair
affiliation: Jawaharlal Institute of Postgraduate Medical Education & Research
facility: 
country: India
url: http://www.ncbi.nlm.nih.gov
description: Pubmed site
citation: Jabbour-Khoury SI, Dabbous AS, Gerges FJ, Azar MS, Ayoub CM, Khoury GS. Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy. JSLS. 2005 Jul-Sep;9(3):316-21.
PMID: 16121879
responsible party type: Principal Investigator
investigator affiliation: Jawaharlal Institute of Postgraduate Medical Education & Research
investigator full name: Dr.D.Ram
investigator title: Junior Resident
mesh term: Respiratory Insufficiency
mesh term: Pain, Postoperative
mesh term: Lidocaine