<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/NCT03004222</url>
  </required_header>
  <id_info>
    <org_study_id>Appendectomy Study</org_study_id>
    <nct_id>NCT03004222</nct_id>
  </id_info>
  <brief_title>A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine</brief_title>
  <official_title>A Randomized Double Blinded Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine: Does it Reduce Post-operative Opioid Use Following Laparoscopic Appendectomy?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Metro Health, Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Metro Health, Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to determine if spraying a local anesthetic to the cecum&#xD;
      after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed&#xD;
      after surgery and reduces the time to discharge from the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine the effectiveness of using intraperitoneal&#xD;
      anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5%&#xD;
      bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the&#xD;
      cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively.&#xD;
      Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic&#xD;
      appendectomy will decrease the amount of narcotic a patient uses postoperatively.&#xD;
      Secondarily, this study will attempt to determine if there is a decrease in length of stay&#xD;
      for the subjects randomized to the anesthetic infiltration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">November 2017</primary_completion_date>
  <phase>N/A</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total narcotic use following surgery until the time of discharge from the hospital.</measure>
    <time_frame>1, 2, 4 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Discharge</measure>
    <time_frame>12 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Level Scores at 1, 2, 4, and 12 hours postoperatively</measure>
    <time_frame>12 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Laparoscopic Appendectomy</condition>
  <arm_group>
    <arm_group_label>Local anesthetic (Bupivicaine)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental arm intervention is 75 subjects will receive the study agent (20 mL of 0.5% bupivacaine) to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo 20 ml</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>75 subjects will be treated with normal saline/placebo to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>20 ml of 0.5% Bupivacaine</description>
    <arm_group_label>Local anesthetic (Bupivicaine)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <arm_group_label>Placebo 20 ml</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years of age and older&#xD;
&#xD;
          -  Laparoscopic appendectomy at Metro Health Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adults unable to consent Non-English speaking patients&#xD;
&#xD;
          -  Suspected or known malignant disease&#xD;
&#xD;
          -  Patients with known allergies to the local anesthetic&#xD;
&#xD;
          -  Utilizes opioid pain medicine for a chronic condition&#xD;
&#xD;
          -  Elective laparoscopic appendectomy&#xD;
&#xD;
          -  Known allergy or contraindication to ketorolac&#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>Karlin Sevensma, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Metro Health Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Metro Health Hospital</name>
      <address>
        <city>Wyoming</city>
        <state>Michigan</state>
        <zip>49519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>January 16, 2018</last_update_submitted>
  <last_update_submitted_qc>January 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</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/NCT03004222
org study id: Appendectomy Study
nct id: NCT03004222
lead sponsor: 
has dmc: No
The purpose of this research is to determine if spraying a local anesthetic to the cecum
      after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed
      after surgery and reduces the time to discharge from the hospital.
The purpose of this study is to determine the effectiveness of using intraperitoneal
      anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5%
      bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the
      cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively.
      Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic
      appendectomy will decrease the amount of narcotic a patient uses postoperatively.
      Secondarily, this study will attempt to determine if there is a decrease in length of stay
      for the subjects randomized to the anesthetic infiltration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Total narcotic use following surgery until the time of discharge from the hospital.
time frame: 1, 2, 4 hours
measure: Time to Discharge
time frame: 12 hours
measure: Pain Level Scores at 1, 2, 4, and 12 hours postoperatively
time frame: 12 hours
arm group label: Local anesthetic (Bupivicaine)
arm group type: Experimental
description: The experimental arm intervention is 75 subjects will receive the study agent (20 mL of 0.5% bupivacaine) to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred
arm group label: Placebo 20 ml
arm group type: Placebo Comparator
description: 75 subjects will be treated with normal saline/placebo to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred
intervention type: Drug
intervention name: Bupivacaine
description: 20 ml of 0.5% Bupivacaine
arm group label: Local anesthetic (Bupivicaine)
intervention type: Drug
intervention name: Placebos
arm group label: Placebo 20 ml
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karlin Sevensma, DO
role: Principal Investigator
affiliation: Metro Health Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bupivacaine
sharing ipd: No