<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/NCT01731782</url>
  </required_header>
  <id_info>
    <org_study_id>02-12-03</org_study_id>
    <nct_id>NCT01731782</nct_id>
  </id_info>
  <brief_title>Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain</brief_title>
  <acronym>TAP Block</acronym>
  <official_title>Evaluation of a TAP Block as Part of an Enhanced Recovery Pathway in Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-blinded Multi-institution Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospitals Cleveland Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients experience pain after surgery mostly from their abdominal wounds, even when those&#xD;
      wounds are small. Decreasing that pain has many benefits. It improves comfort, decreases&#xD;
      stress response and might improve the outcome of the surgery. Local anesthesia (which is a&#xD;
      numbing agent given directly at the site of pain via a needle) is given to decrease the pain&#xD;
      that is felt after surgery and decrease the need for strong pain medications which can have&#xD;
      negative side effects.&#xD;
&#xD;
      One promising way to give local pain medication is called the &quot;transversus abdominis plane&quot;&#xD;
      or TAP block. This method works by directly blocking the nerves in the abdomen that are the&#xD;
      cause of the pain patients feel in their incision after surgery. This is done by injecting a&#xD;
      numbing agent (Bupivacaine) into the area of their abdomen where their nerves are located&#xD;
      that cause pain.&#xD;
&#xD;
      In the case of nerves that carry sensation, bupivacaine blocks the pain sensation traveling&#xD;
      in a particular nerve.&#xD;
&#xD;
      Patients will be randomized (like a flip of a coin) to receive either a normal saline&#xD;
      injection or the bupivacaine injection.&#xD;
&#xD;
      The purpose of this study will be to prove the effectiveness of local anesthetic given via a&#xD;
      TAP block in improving postoperative pain, decreasing the use of pain medications, decreasing&#xD;
      postoperative nausea and vomiting and improve surgical outcomes such as hospital length of&#xD;
      stay in laparoscopic colorectal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using standard surgical procedures, the surgeon will proceed with the planned laparoscopic&#xD;
      surgery. All procedures will be done by straight laparoscopic technique according to standard&#xD;
      of care. At the completion of the procedure, and under laparoscopic control, patients will&#xD;
      have a TAP block placed by the attending surgeon. The clinical research nurse involved in the&#xD;
      research will prep the solution to be injected and the surgeon will be blinded as to whether&#xD;
      the patient will be receiving normal saline or Marcaine in the TAP blocks. The block will be&#xD;
      administered between the costal margin and iliac crest in the anterior axillary line. A Braun&#xD;
      Stimuplex A insulated needle (80 mm 21 gauge) with 0.5 mL/kg solution (max of 30 ml) is&#xD;
      passed through the skin, and then continued until two distinct &quot;pops&quot; are felt, which&#xD;
      indicates the needle piercing each of the two fascial layers. The needle is then deemed to be&#xD;
      in the inter-muscular plane between internal oblique and transversus abdominis muscles&#xD;
      respectively, to target the spinal nerves in this plane. The laparoscope will be visualizing&#xD;
      for the needle tip to ensure that it does not penetrate the peritoneum or inject&#xD;
      pre-peritoneally. The local anesthetic is infiltrated in two separate injections into the&#xD;
      same plane on each side. If a sub-peritoneal bleb is seen to be raised by the laparoscope,&#xD;
      then the needle will be withdrawn slightly. Two thirds of the solution is injected, and the&#xD;
      needle is withdrawn 5 mm and the remaining solution is injected. If injecting in the correct&#xD;
      plane, then a smooth raised area of fluid, covered by transversus will be seen via the&#xD;
      laparoscope. This procedure is repeated on the patients other side, to complete a bilateral&#xD;
      block. Depending on their randomization, patients will receive one of the following&#xD;
      solutions:&#xD;
&#xD;
      Group A: Represents the control group and will receive 0.5 ml/kg of 0.9% normal saline for a&#xD;
      maximum of 30 ml.&#xD;
&#xD;
      Group B: Represents the experimental group and will receive 0.5 ml/kg of 0.25% Marcaine&#xD;
      (bupivacaine) for a maximum of 30 ml.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain as Measured by Pain Score</measure>
    <time_frame>up to 10 days</time_frame>
    <description>Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Analgesics Used as Measured by Patient Report</measure>
    <time_frame>Up to 30 days after surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Nausea/Vomiting Episodes</measure>
    <time_frame>up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>up to 10 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Day of Return of Bowel Function</measure>
    <time_frame>daily after surgery until discharge up to 10 days</time_frame>
    <description>Log the day bowel function returns by day postoperative that flatus returns and has first stool</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Colorectal Disease</condition>
  <arm_group>
    <arm_group_label>bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bupivacaine</intervention_name>
    <arm_group_label>bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline placebo (for bupivacaine)</intervention_name>
    <description>Normal saline to mimic bupivacaine</description>
    <arm_group_label>normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have benign or malignant colonic or rectal disease that are being&#xD;
             scheduled for laparoscopic colorectal resection.&#xD;
&#xD;
          2. Subjects who are 18 years of age and older&#xD;
&#xD;
          3. Subjects of either sex&#xD;
&#xD;
          4. Subjects who are willing and able to adhere to protocol requirements, agree to&#xD;
             participate in the study program and provide written and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who undergo conversion to the open approach will be excluded from the&#xD;
             analysis, as the block will be given at the end of the procedure and is being&#xD;
             evaluated for laparoscopic cases.&#xD;
&#xD;
          2. Subjects who are pregnant.&#xD;
&#xD;
          3. Subjects with a medical condition that may interfere with the use of the study&#xD;
             medication Bupivicaine.&#xD;
&#xD;
          4. Subjects who have another condition or general disability or infirmity that in the&#xD;
             opinion of the investigator precludes further participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Conor P Delaney, MD.,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <results_first_submitted>July 21, 2022</results_first_submitted>
  <results_first_submitted_qc>October 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 3, 2022</results_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colorectal surgery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 16, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT01731782/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bupivacaine</title>
          <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml&#xD;
bupivacaine</description>
        </group>
        <group group_id="P2">
          <title>Normal Saline</title>
          <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine&#xD;
normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bupivacaine</title>
          <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml&#xD;
bupivacaine</description>
        </group>
        <group group_id="B2">
          <title>Normal Saline</title>
          <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine&#xD;
normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="79"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.34" spread="14.16"/>
                    <measurement group_id="B2" value="64.82" spread="13.11"/>
                    <measurement group_id="B3" value="66.12" spread="13.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain as Measured by Pain Score</title>
        <description>Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain</description>
        <time_frame>up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml&#xD;
bupivacaine</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline</title>
            <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine&#xD;
normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain as Measured by Pain Score</title>
          <description>Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="2.09"/>
                    <measurement group_id="O2" value="3.46" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Analgesics Used as Measured by Patient Report</title>
        <time_frame>Up to 30 days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml&#xD;
bupivacaine</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline</title>
            <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine&#xD;
normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Analgesics Used as Measured by Patient Report</title>
          <units>percentage of analgesics used</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.80" spread="0.52"/>
                    <measurement group_id="O2" value="1.79" spread="0.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Nausea/Vomiting Episodes</title>
        <time_frame>up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml&#xD;
bupivacaine</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline</title>
            <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine&#xD;
normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Nausea/Vomiting Episodes</title>
          <units>Episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of Hospital Stay</title>
        <time_frame>up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine</title>
            <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml&#xD;
bupivacaine</description>
          </group>
          <group group_id="O2">
            <title>Normal Saline</title>
            <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine&#xD;
normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.15" spread="2.03"/>
                    <measurement group_id="O2" value="2.87" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Day of Return of Bowel Function</title>
        <description>Log the day bowel function returns by day postoperative that flatus returns and has first stool</description>
        <time_frame>daily after surgery until discharge up to 10 days</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 30 days postop</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bupivacaine</title>
          <description>bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml&#xD;
bupivacaine</description>
        </group>
        <group group_id="E2">
          <title>Normal Saline</title>
          <description>Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine&#xD;
normal saline placebo (for bupivacaine): Normal saline to mimic bupivacaine</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <description>Patient remained in the study</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Conor Delaney</name_or_title>
      <organization>Cleveland Clinic Florida Region</organization>
      <phone>954-659-6001</phone>
      <email>DELANEC@ccf.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01731782
org study id: 02-12-03
nct id: NCT01731782
lead sponsor: 
has dmc: Yes
Patients experience pain after surgery mostly from their abdominal wounds, even when those
      wounds are small. Decreasing that pain has many benefits. It improves comfort, decreases
      stress response and might improve the outcome of the surgery. Local anesthesia (which is a
      numbing agent given directly at the site of pain via a needle) is given to decrease the pain
      that is felt after surgery and decrease the need for strong pain medications which can have
      negative side effects.

      One promising way to give local pain medication is called the "transversus abdominis plane"
      or TAP block. This method works by directly blocking the nerves in the abdomen that are the
      cause of the pain patients feel in their incision after surgery. This is done by injecting a
      numbing agent (Bupivacaine) into the area of their abdomen where their nerves are located
      that cause pain.

      In the case of nerves that carry sensation, bupivacaine blocks the pain sensation traveling
      in a particular nerve.

      Patients will be randomized (like a flip of a coin) to receive either a normal saline
      injection or the bupivacaine injection.

      The purpose of this study will be to prove the effectiveness of local anesthetic given via a
      TAP block in improving postoperative pain, decreasing the use of pain medications, decreasing
      postoperative nausea and vomiting and improve surgical outcomes such as hospital length of
      stay in laparoscopic colorectal surgery.
Using standard surgical procedures, the surgeon will proceed with the planned laparoscopic
      surgery. All procedures will be done by straight laparoscopic technique according to standard
      of care. At the completion of the procedure, and under laparoscopic control, patients will
      have a TAP block placed by the attending surgeon. The clinical research nurse involved in the
      research will prep the solution to be injected and the surgeon will be blinded as to whether
      the patient will be receiving normal saline or Marcaine in the TAP blocks. The block will be
      administered between the costal margin and iliac crest in the anterior axillary line. A Braun
      Stimuplex A insulated needle (80 mm 21 gauge) with 0.5 mL/kg solution (max of 30 ml) is
      passed through the skin, and then continued until two distinct "pops" are felt, which
      indicates the needle piercing each of the two fascial layers. The needle is then deemed to be
      in the inter-muscular plane between internal oblique and transversus abdominis muscles
      respectively, to target the spinal nerves in this plane. The laparoscope will be visualizing
      for the needle tip to ensure that it does not penetrate the peritoneum or inject
      pre-peritoneally. The local anesthetic is infiltrated in two separate injections into the
      same plane on each side. If a sub-peritoneal bleb is seen to be raised by the laparoscope,
      then the needle will be withdrawn slightly. Two thirds of the solution is injected, and the
      needle is withdrawn 5 mm and the remaining solution is injected. If injecting in the correct
      plane, then a smooth raised area of fluid, covered by transversus will be seen via the
      laparoscope. This procedure is repeated on the patients other side, to complete a bilateral
      block. Depending on their randomization, patients will receive one of the following
      solutions:

      Group A: Represents the control group and will receive 0.5 ml/kg of 0.9% normal saline for a
      maximum of 30 ml.

      Group B: Represents the experimental group and will receive 0.5 ml/kg of 0.25% Marcaine
      (bupivacaine) for a maximum of 30 ml.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Postoperative Pain as Measured by Pain Score
time frame: up to 10 days
description: Pain measured via score of 1 to 5, with 1 being no pain and 5 being the worst pain
measure: Percent of Analgesics Used as Measured by Patient Report
time frame: Up to 30 days after surgery
measure: Number of Nausea/Vomiting Episodes
time frame: up to 10 days
measure: Length of Hospital Stay
time frame: up to 10 days
measure: Day of Return of Bowel Function
time frame: daily after surgery until discharge up to 10 days
description: Log the day bowel function returns by day postoperative that flatus returns and has first stool
arm group label: bupivacaine
arm group type: Active Comparator
description: bupivacaine-0.5ml/kg of 25% bupivacaine for maximum of 30ml
arm group label: normal saline
arm group type: Placebo Comparator
description: Normal saline placebo-0.5ml/kg of 0.9% normal saline (max of 30ml)to mimic bupivacaine
intervention type: Drug
intervention name: bupivacaine
arm group label: bupivacaine
other name: Marcaine
intervention type: Drug
intervention name: normal saline placebo (for bupivacaine)
description: Normal saline to mimic bupivacaine
arm group label: normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Conor P Delaney, MD.,PhD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bupivacaine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 