<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/NCT03265223</url>
  </required_header>
  <id_info>
    <org_study_id>JawaharlalNMC</org_study_id>
    <nct_id>NCT03265223</nct_id>
  </id_info>
  <brief_title>Ropivacaine Use Intraincisionally Versus Intraperitoneally for Post-Laparoscopic Cholecystectomy Pain</brief_title>
  <official_title>Randomized Controlled Study of Intraincisional Infiltration Versus Intraperitoneal Instillation of Standardized Dose of Ropivacaine 0.2% in Post-laparoscopic Cholecystectomy Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jawaharlal Nehru Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jawaharlal Nehru Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic&#xD;
      cholecystectomy. Almost all earlier studies done to compare the efficacy of local&#xD;
      anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of&#xD;
      drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small&#xD;
      space of intraincisional location as compared to similar amount of drug in large&#xD;
      intraperitoneal space created an inadvertent bias in favor of patients receiving the drug&#xD;
      intraincisionally so such patients naturally experienced less pain. The investigators decided&#xD;
      to standardize the drug used at these two locations as 1ml/cm and conduct a new study&#xD;
      comparing the effects of drugs in relieving pain when used at these two locations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims &amp; Objectives: To conduct a randomized, triple-blind, placebo-controlled study by&#xD;
      standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal&#xD;
      against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain&#xD;
      relief.&#xD;
&#xD;
      Materials &amp; Methods: American Society of Anesthesiologists (ASA) physical status I or II&#xD;
      patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon.&#xD;
      Anesthetic and surgical techniques were standardized. Patients were randomized using envelope&#xD;
      method into 3 groups according to location of drug use. Triple blinding was ensured and&#xD;
      envelopes were opened only at the completion of study. All patients received ~23 ml of&#xD;
      solution, of which 20 ml was given intraperitoneally [1 ml/cm; 16 ml along right hemi-dome,&#xD;
      approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in&#xD;
      gall bladder fossa) and ~3 ml intraincisionally (1 ml/cm of length of incision). Controls&#xD;
      (n=86) received ~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally)&#xD;
      while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of&#xD;
      injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of&#xD;
      procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1&#xD;
      ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure.&#xD;
      All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly&#xD;
      postoperatively. 5 different pain scales were used for assessment of overall pain. Pain&#xD;
      scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours&#xD;
      postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were&#xD;
      also recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">August 15, 2017</completion_date>
  <primary_completion_date type="Actual">March 31, 2017</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>
    <intervention_model_description>Three study groups: Controls received no drug, intraperitoneal group received drug along right hemidiaphragm and in gallbladder fossa while intraincisional group received drug by infiltration at trocar site</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Triple blinding was done i.e. neither the operating surgeon nor the investigator and nor the patient knew to which study group patient belong to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain</measure>
    <time_frame>36 months</time_frame>
    <description>To study and assess the effect and impact of using the local anesthetic ropivacaine 0.2%, over controls, on the intensity of postoperative pain in patients undergoing laparoscopic cholecystectomy; and to compare and assess the optimal site i.e. intraincisional versus intraperitoneal of using local anesthetic (ropivacaine) for better post-laparoscopic cholecystectomy pain relief.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identify the component of pain which is dominant after undergoing laparoscopic cholecystectomy</measure>
    <time_frame>36 months</time_frame>
    <description>To identify the component of pain (visceral versus incisional component) that is dominant after laparoscopic cholecystectomy; and after how much interval of time it assumes importance?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laparoscopic cholecystectomy as day-case using ropivacaine only</measure>
    <time_frame>36 months</time_frame>
    <description>To strive for making laparoscopic cholecystectomy a truly day case procedure in the public setup of developing countries like India by using this cheap local anaesthetic alone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changing trends in epidemiology of cholelithiasis</measure>
    <time_frame>36 months</time_frame>
    <description>To check for any changing trends in epidemiology of cholelithiasis in North India</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">353</enrollment>
  <condition>Ropivacaine</condition>
  <condition>Laparoscopic Cholecystectomy</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Received 1 ml/cm normal saline (23 ml) both at intraperitoneal (=20 ml) as well as intraincisional (=3 ml) location.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intraperitoneal group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Received 20 ml of 0.2% ropivacaine intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml normal saline (1ml/cm of port site incision length)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intraincisional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Received 20 ml of normal saline intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml 0.2% ropivacaine (1ml/cm of port site incision length)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.2% ropivacaine</intervention_name>
    <description>Intraperitoneal instillation versus intraincisional infiltration</description>
    <arm_group_label>Intraincisional group</arm_group_label>
    <arm_group_label>Intraperitoneal group</arm_group_label>
    <other_name>Ropin</other_name>
    <other_name>Naropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients in the age group of 15-80 years&#xD;
&#xD;
          -  Patients conferring to Grade I or II of American Society of Anesthesiologists (ASA)&#xD;
             physical status classification system only&#xD;
&#xD;
          -  Patients undergoing elective Laparoscopic Cholecystectomy&#xD;
&#xD;
          -  Patients having symptomatic cholelithiasis only&#xD;
&#xD;
          -  Patients operated by a single surgeon were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known allergic reactions to local anesthetics&#xD;
&#xD;
          -  Cases that were converted to open cholecystectomy&#xD;
&#xD;
          -  Patients with major intra-operative complications&#xD;
&#xD;
          -  Patients suffering from acute cholecystitis, empyema or malignancy of gall bladder,&#xD;
             having history of chronic pain or those taking frequent analgesics or opioids&#xD;
             pre-operatively&#xD;
&#xD;
          -  Patients with peptic ulceration, bleeding disorders, impaired renal and/or hepatic&#xD;
             function, and sensitivity to NSAIDs or opioids.&#xD;
&#xD;
          -  Patients in whom gall bladder (GB) stones are found incidentally on ultrasonography&#xD;
             (USG) (asymptomatic cholelithiasis)&#xD;
&#xD;
          -  Patients suffering from severe chronic medical diseases and morbid obesity&#xD;
&#xD;
          -  Patients unable to comprehend instructions or having communication problems were&#xD;
             excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kaushal D Singh, MS Surgery</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jawaharlal Nehru Medical College, Aligarh</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jawaharlal Nehru Medical College</investigator_affiliation>
    <investigator_full_name>Kaushal Deep Singh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ropivacaine</keyword>
  <keyword>local anesthesia</keyword>
  <keyword>intraincisional infiltration</keyword>
  <keyword>intraperitoneal instillation</keyword>
  <keyword>post-laparoscopic cholecystectomy pain</keyword>
  <keyword>shoulder pain</keyword>
  <keyword>rescue analgesia</keyword>
  <keyword>triple blinding</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data of those patients will be shared patients who will give consent for the same.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03265223/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03265223/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 1, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03265223/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 31, 2017</submitted>
    <returned>September 26, 2017</returned>
  </pending_results>
  <!-- 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/NCT03265223
org study id: JawaharlalNMC
nct id: NCT03265223
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic
      cholecystectomy. Almost all earlier studies done to compare the efficacy of local
      anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of
      drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small
      space of intraincisional location as compared to similar amount of drug in large
      intraperitoneal space created an inadvertent bias in favor of patients receiving the drug
      intraincisionally so such patients naturally experienced less pain. The investigators decided
      to standardize the drug used at these two locations as 1ml/cm and conduct a new study
      comparing the effects of drugs in relieving pain when used at these two locations.
Aims & Objectives: To conduct a randomized, triple-blind, placebo-controlled study by
      standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal
      against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain
      relief.

      Materials & Methods: American Society of Anesthesiologists (ASA) physical status I or II
      patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon.
      Anesthetic and surgical techniques were standardized. Patients were randomized using envelope
      method into 3 groups according to location of drug use. Triple blinding was ensured and
      envelopes were opened only at the completion of study. All patients received ~23 ml of
      solution, of which 20 ml was given intraperitoneally [1 ml/cm; 16 ml along right hemi-dome,
      approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in
      gall bladder fossa) and ~3 ml intraincisionally (1 ml/cm of length of incision). Controls
      (n=86) received ~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally)
      while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of
      injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of
      procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1
      ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure.
      All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly
      postoperatively. 5 different pain scales were used for assessment of overall pain. Pain
      scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours
      postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were
      also recorded.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Three study groups: Controls received no drug, intraperitoneal group received drug along right hemidiaphragm and in gallbladder fossa while intraincisional group received drug by infiltration at trocar site
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Triple blinding was done i.e. neither the operating surgeon nor the investigator and nor the patient knew to which study group patient belong to.
measure: Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain
time frame: 36 months
description: To study and assess the effect and impact of using the local anesthetic ropivacaine 0.2%, over controls, on the intensity of postoperative pain in patients undergoing laparoscopic cholecystectomy; and to compare and assess the optimal site i.e. intraincisional versus intraperitoneal of using local anesthetic (ropivacaine) for better post-laparoscopic cholecystectomy pain relief.
measure: Identify the component of pain which is dominant after undergoing laparoscopic cholecystectomy
time frame: 36 months
description: To identify the component of pain (visceral versus incisional component) that is dominant after laparoscopic cholecystectomy; and after how much interval of time it assumes importance?
measure: Laparoscopic cholecystectomy as day-case using ropivacaine only
time frame: 36 months
description: To strive for making laparoscopic cholecystectomy a truly day case procedure in the public setup of developing countries like India by using this cheap local anaesthetic alone
measure: Changing trends in epidemiology of cholelithiasis
time frame: 36 months
description: To check for any changing trends in epidemiology of cholelithiasis in North India
arm group label: Controls
arm group type: No Intervention
description: Received 1 ml/cm normal saline (23 ml) both at intraperitoneal (=20 ml) as well as intraincisional (=3 ml) location.
arm group label: Intraperitoneal group
arm group type: Active Comparator
description: Received 20 ml of 0.2% ropivacaine intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml normal saline (1ml/cm of port site incision length)
arm group label: Intraincisional group
arm group type: Active Comparator
description: Received 20 ml of normal saline intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml 0.2% ropivacaine (1ml/cm of port site incision length)
intervention type: Drug
intervention name: 0.2% ropivacaine
description: Intraperitoneal instillation versus intraincisional infiltration
arm group label: Intraincisional group
arm group label: Intraperitoneal group
other name: Ropin
other name: Naropin
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kaushal D Singh, MS Surgery
role: Principal Investigator
affiliation: Jawaharlal Nehru Medical College, Aligarh
responsible party type: Principal Investigator
investigator affiliation: Jawaharlal Nehru Medical College
investigator full name: Kaushal Deep Singh
investigator title: Principal Investigator
mesh term: Ropivacaine
sharing ipd: Undecided
ipd description: Data of those patients will be shared patients who will give consent for the same.
provided document: 
provided document: 
provided document: 
submitted: August 31, 2017
returned: September 26, 2017