<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/NCT03022279</url>
  </required_header>
  <id_info>
    <org_study_id>1410511719</org_study_id>
    <nct_id>NCT03022279</nct_id>
  </id_info>
  <brief_title>Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children</brief_title>
  <official_title>Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brian Wallace Gray</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare transversus abdominis plane (TAP) blocks to local&#xD;
      wound infiltration (LWI) in terms of postoperative pain control in pediatric patients&#xD;
      undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be&#xD;
      superior to LWI for postoperative pain control resulting in decreased use of opioid /&#xD;
      narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative&#xD;
      period. The rationale is that determining the effect of analgesia in this pediatric&#xD;
      population is important to optimize clinical care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, patients ages 8 through 17 years scheduled for elective laparoscopic&#xD;
      cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy&#xD;
      procedures will also be eligible. The da Vinci System is a minimally invasive option&#xD;
      utilizing robotic technology. Once randomized, the patient will undergo either ultrasound&#xD;
      guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective&#xD;
      data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will&#xD;
      be collected for both groups. Due to the nature of the study, it will not be possible to&#xD;
      blind the investigators to the randomly selected method of injecting local anesthesia;&#xD;
      however the personnel involved in the post-anesthetic and post-operative assessment will be&#xD;
      blinded to the intervention, as well as the subjects themselves.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 6, 2017</start_date>
  <completion_date type="Actual">September 2022</completion_date>
  <primary_completion_date type="Actual">September 2022</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>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of narcotic pain medication</measure>
    <time_frame>24 hours post-op</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to first request of pain medication</measure>
    <time_frame>From post-anesthesia care unit &quot;(PACU) in&quot; time to first pain medication dose, up to 24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Laparoscopic Cholecystectomy</condition>
  <arm_group>
    <arm_group_label>TAP blocks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Local Wound Infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Local wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>TAP Blocks</intervention_name>
    <description>ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine</description>
    <arm_group_label>TAP blocks</arm_group_label>
    <other_name>nerve block</other_name>
    <other_name>transversus abdominis plane block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>local wound infiltration</intervention_name>
    <description>local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine</description>
    <arm_group_label>Local Wound Infiltration</arm_group_label>
    <other_name>local wound injections</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 8-17 yrs of age at date of enrollment.&#xD;
&#xD;
          2. Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic pain or chronic use of narcotic or other prescription pain medications.&#xD;
&#xD;
          2. Use of pain medication within 24 hours before surgery&#xD;
&#xD;
          3. Prior major abdominal surgery&#xD;
&#xD;
          4. Evidence of acute inflammation&#xD;
&#xD;
          5. Patients with acute cholecystitis&#xD;
&#xD;
          6. Bleeding / coagulation disorder&#xD;
&#xD;
          7. Seizure disorder&#xD;
&#xD;
          8. Renal dysfunction&#xD;
&#xD;
          9. Infection at injection sites for TAP block or trocar placement&#xD;
&#xD;
         10. Contraindication to LWI or TAP block procedure, as determined by surgeon or&#xD;
             anesthesiologist performing the procedure (including, but not limited to, previous&#xD;
             incision distorting anatomy or inability to visualize anatomical planes)&#xD;
&#xD;
         11. Any known allergy to medications used in this study&#xD;
&#xD;
         12. Patient unable to verbalize pain score or independently assess pain level&#xD;
&#xD;
         13. Unstable patient in need of emergent intervention at surgeon discretion&#xD;
&#xD;
         14. Patients who are known to be pregnant&#xD;
&#xD;
         15. Patients who are currently prisoners&#xD;
&#xD;
         16. Children in custody of the state&#xD;
&#xD;
         17. Subjects will a BMI &gt;/= 50&#xD;
&#xD;
         18. Investigator discretion for any other reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gray Brian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Riley Hospital for Children at IU Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Brian Wallace Gray</investigator_full_name>
    <investigator_title>Pediatric surgeon</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <keyword>post-operative pain prevention</keyword>
  <keyword>Anesthesia, Infiltration</keyword>
  <keyword>Nerve Blockade</keyword>
  <!-- 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/NCT03022279
org study id: 1410511719
nct id: NCT03022279
lead sponsor: 
has dmc: Yes
The objective of this study is to compare transversus abdominis plane (TAP) blocks to local
      wound infiltration (LWI) in terms of postoperative pain control in pediatric patients
      undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be
      superior to LWI for postoperative pain control resulting in decreased use of opioid /
      narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative
      period. The rationale is that determining the effect of analgesia in this pediatric
      population is important to optimize clinical care.
In this study, patients ages 8 through 17 years scheduled for elective laparoscopic
      cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy
      procedures will also be eligible. The da Vinci System is a minimally invasive option
      utilizing robotic technology. Once randomized, the patient will undergo either ultrasound
      guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective
      data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will
      be collected for both groups. Due to the nature of the study, it will not be possible to
      blind the investigators to the randomly selected method of injecting local anesthesia;
      however the personnel involved in the post-anesthetic and post-operative assessment will be
      blinded to the intervention, as well as the subjects themselves.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: Amount of narcotic pain medication
time frame: 24 hours post-op
measure: Time to first request of pain medication
time frame: From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours
arm group label: TAP blocks
arm group type: Active Comparator
description: TAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites).
arm group label: Local Wound Infiltration
arm group type: Active Comparator
description: Local wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis.
intervention type: Procedure
intervention name: TAP Blocks
description: ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
arm group label: TAP blocks
other name: nerve block
other name: transversus abdominis plane block
intervention type: Procedure
intervention name: local wound infiltration
description: local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
arm group label: Local Wound Infiltration
other name: local wound injections
criteria: 
gender: All
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Gray Brian, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Indiana University
investigator full name: Brian Wallace Gray
investigator title: Pediatric surgeon