<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/NCT03262688</url>
  </required_header>
  <id_info>
    <org_study_id>INN-CB-020</org_study_id>
    <nct_id>NCT03262688</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, PK, and Analgesic Effect of INL-001 in Children Following Open Inguinal Hernia Repair</brief_title>
  <official_title>A Multicenter, Randomized, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Analgesic Effect of the INL-001 Bupivacaine Hydrochloride (HCl) Collagen-Matrix Implant in Children 2 to &lt;17 Years of Age Following Open Inguinal Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innocoll</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Premier Research Group plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Innocoll</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, single-dose study in children 12 to &lt;17 years of age, 6 to &lt;12 years of age,&#xD;
      and 2 to &lt;6 years of age who are scheduled for elective open inguinal hernia repair.&#xD;
      Enrollment in this study will start with the oldest age group (12 to &lt;17 years) and will&#xD;
      continue in a stepwise fashion until appropriate doses are established for all 3 pediatric&#xD;
      age groups (12 to &lt;17 years, 6 to &lt;12 years, 2 to &lt;6 years).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, single-dose study in children 12 to &lt;17 years of age, 6 to &lt;12 years&#xD;
      of age, and 2 to &lt;6 years of age who are scheduled for elective open inguinal hernia repair.&#xD;
      Within 21 days of surgery, eligible subjects will be screened and have routine clinical&#xD;
      laboratory testing and an electrocardiogram performed. Subjects will then undergo an open&#xD;
      inguinal hernia repair under general anesthesia according to the investigator's standard&#xD;
      surgical practice on day 1. Enrollment in this study will start with the oldest age group (12&#xD;
      to &lt;17 years) and will continue in a stepwise fashion until appropriate doses are established&#xD;
      for all 3 pediatric age groups. Within each age group, the study will be conducted in 3&#xD;
      parts.&#xD;
&#xD;
      Children in each age group who are randomized to INL-001 will receive approximately less than&#xD;
      or equal to 2.5 mg/kg of INL-001. Study drug will be administered prior to wound closure. The&#xD;
      INL-001 implant will be cut before placement into the surgical site using sterile technique.&#xD;
      Children randomized to 0.25% bupivacaine HCl injection will receive 2.5 mg/kg according to&#xD;
      standard practice.&#xD;
&#xD;
      After completion of the surgical procedure, all subjects will remain in the post-anesthesia&#xD;
      care unit for at least 3 hours and will be continuously monitored for safety. At the&#xD;
      discretion of the investigator, subjects may receive rescue medication (opioid or nonopioid)&#xD;
      upon request for the management of breakthrough pain and may receive an antiemetic for the&#xD;
      management of nausea or vomiting. After the initial 3-hour period, subjects who are deemed&#xD;
      stable may be discharged to the hospital ward. Subjects will remain housed in the hospital&#xD;
      ward for at least 48 hours. Blood samples will be collected for pharmacokinetic analysis from&#xD;
      a subset of 8 children in each age group after INL-001 is implanted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 16, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>Phase 3</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>Randomized, controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Participant, legal guardian and study personnel involved in the assessment of efficacy and safety are blinded to treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 days</time_frame>
    <description>Possibly related to bupivacaine toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure (systolic/diastolic)</measure>
    <time_frame>Starting at Time 0 and continuing for 3 hours and then 5, 8, 12, 24, 36, and 48 hours after Time 0</time_frame>
    <description>Signs/symptoms of bupivacaine toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0</time_frame>
    <description>Signs/symptoms of bupivacaine toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory rate</measure>
    <time_frame>Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0</time_frame>
    <description>Signs/symptoms of bupivacaine toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body temperature</measure>
    <time_frame>Through Day 30</time_frame>
    <description>Signs/symptoms of bupivacaine toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12-lead ECG</measure>
    <time_frame>1 day at screening</time_frame>
    <description>Screening only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3-lead ECG</measure>
    <time_frame>Starting at Time 0 and continuing for at least 3 hours</time_frame>
    <description>Signs/symptoms of bupivacaine toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen saturation levels</measure>
    <time_frame>Starting at Time 0 and continuing for at least 3 hours</time_frame>
    <description>Pulse oximetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical laboratory testing</measure>
    <time_frame>1 day at screening</time_frame>
    <description>Collection of blood and urine samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wound healing assessments</measure>
    <time_frame>Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30</time_frame>
    <description>Inspection of surgical wound site for signs of wound infection and dehiscence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nausea</measure>
    <time_frame>1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0</time_frame>
    <description>Measured using a categorical scoring system (none = 0, mild = 1, moderate = 2, and severe = 3). Nausea scores will also be recorded immediately before the use of rescue antiemetics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sedation</measure>
    <time_frame>1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0</time_frame>
    <description>Sedation scores: awake and alert = 0, quietly awake = 1, asleep but easily roused = 2, and deep sleep = 3.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0.</time_frame>
    <description>Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-last</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0</time_frame>
    <description>Area under the plasma concentration time curve from Time zero to last quantifiable plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-∞</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0</time_frame>
    <description>Area under the plasma concentration time curve from Time zero to extrapolated through infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0</time_frame>
    <description>Time to maximum obserbved plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0</time_frame>
    <description>Apparent first-order terminal elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0</time_frame>
    <description>Assessed using an 11-point NRS (for children 12 to &lt;17 years of age), a FACES pain severity scale (children 4 through &lt;12 years of age), or FLACC (children 2 and 3 years of age) immediately before the child receives any parenteral or oral rescue medication for breakthrough pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">159</enrollment>
  <condition>Inguinal Hernia</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>INL-001</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bupivacaine HCl collagen-matrix implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Infiltration</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine HCl infiltration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine HCl collagen-matrix implant</intervention_name>
    <description>Placement of the bupivacaine collagen-matrix in the surgical site</description>
    <arm_group_label>INL-001</arm_group_label>
    <other_name>Xaracoll</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine HCl infiltration</intervention_name>
    <description>Infiltration of the surgical site</description>
    <arm_group_label>Infiltration</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a male or female 2 to &lt;17 years of age.&#xD;
&#xD;
          -  Be eligible for an elective open inguinal hernia repair that will be performed&#xD;
             according to standard surgical technique under general anesthesia.&#xD;
&#xD;
          -  Be premenarche or have a serum confirmed negative pregnancy test at screening and a&#xD;
             negative urine pregnancy test before surgery on day 1, if an adolescent female of&#xD;
             childbearing potential.&#xD;
&#xD;
          -  Be willing and able to cooperate with all the requirements of the study.&#xD;
&#xD;
          -  Be able to speak and understand English or Spanish.&#xD;
&#xD;
          -  Have a legally authorized representative (eg, parent, guardian) who is able to read,&#xD;
             speak, and understand English or Spanish and who will voluntarily sign and date a&#xD;
             parental permission/informed consent form that is approved by the Institutional Review&#xD;
             Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).&#xD;
&#xD;
          -  Be willing to sign an assent (if appropriate dependent upon the child's age,&#xD;
             understanding, and IRB requirements), before the conduct of any study procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a known hypersensitivity to amide local anesthetics, bovine products, or to&#xD;
             inactive ingredients of the study drugs.&#xD;
&#xD;
          -  Requires any additional surgical procedures, either related or unrelated to the&#xD;
             scheduled surgery (ie, open inguinal hernia surgery), during the same hospitalization.&#xD;
&#xD;
          -  Requires epidural or spinal blockade perioperatively.&#xD;
&#xD;
          -  Is required to receive neuraxial (spinal or epidural) opioid analgesics during the&#xD;
             study.&#xD;
&#xD;
          -  Has undergone major surgery within 3 months of the scheduled surgery or plans to&#xD;
             undergo another surgical procedure within the 30-day postoperative period.&#xD;
&#xD;
          -  Has known or suspected history of drug abuse or misuse or evidence of tolerance or&#xD;
             physical dependency on opioid analgesics or sedative-hypnotic medications.&#xD;
&#xD;
          -  Has participated in a clinical trial (investigational or marketed product) within 30&#xD;
             days before surgery.&#xD;
&#xD;
          -  Has any clinically significant medical history or condition (eg, unstable cardiac,&#xD;
             neurological, immunological, renal, hepatic, or hematological disease or any other&#xD;
             condition) that in the opinion of the investigator, substantially increases the risk&#xD;
             associated with the subject's participation in the protocol or compromises the&#xD;
             scientific objectives of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gwendolyn Niebler, DO</last_name>
    <role>Study Director</role>
    <affiliation>Innocoll</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nina Head of Clinical Operations</last_name>
    <phone>484-406-5214</phone>
    <email>rsmall@innocoll.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nina Head of Clinical Research, MD</last_name>
    <phone>484-406-5205</phone>
    <email>nskuban@innocoll.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Alliance Research Centers</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tracy Bessette</last_name>
      <phone>949-680-3490</phone>
      <email>tbessette@researchalliance.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cornerstone Research Institute</name>
      <address>
        <city>Altamonte Springs</city>
        <state>Florida</state>
        <zip>32701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Derrica Robinson</last_name>
      <phone>407-729-1236</phone>
      <email>drobinson@cornerstonestudy.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Medical Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Elion &amp; Volhard Pharmaceutical Research (E&amp;V PR)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC (CHP-UPMC)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Denise McCarthy</last_name>
      <phone>412-692-5585</phone>
      <email>mccarthydj@anes.upmc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Driscoll Children's Hospital</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78411</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Debhanhi Gaylan</last_name>
      <phone>540-314-1838</phone>
      <email>debhanhi@researchhd.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>El Paso Children's Hospital</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isaac Martinez</last_name>
      <phone>915-244-0751</phone>
      <email>isaac@researchhd.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Memorial City Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jayme Carr</last_name>
      <phone>832-524-7177</phone>
      <email>jayme@researchHD.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Woman's Hospital of Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Plano Surgical Hospital</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Kade</last_name>
      <phone>410-614-5775</phone>
      <email>laura@researchhd.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jean Brown Research</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 23, 2021</last_update_submitted>
  <last_update_submitted_qc>July 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>INL-001</keyword>
  <keyword>Bupivacaine</keyword>
  <keyword>Collagen</keyword>
  <keyword>Children</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Inguinal hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</mesh_term>
  </condition_browse>
  <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/NCT03262688
org study id: INN-CB-020
nct id: NCT03262688
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age,
      and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
      Enrollment in this study will start with the oldest age group (12 to <17 years) and will
      continue in a stepwise fashion until appropriate doses are established for all 3 pediatric
      age groups (12 to <17 years, 6 to <12 years, 2 to <6 years).
This is a multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years
      of age, and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
      Within 21 days of surgery, eligible subjects will be screened and have routine clinical
      laboratory testing and an electrocardiogram performed. Subjects will then undergo an open
      inguinal hernia repair under general anesthesia according to the investigator's standard
      surgical practice on day 1. Enrollment in this study will start with the oldest age group (12
      to <17 years) and will continue in a stepwise fashion until appropriate doses are established
      for all 3 pediatric age groups. Within each age group, the study will be conducted in 3
      parts.

      Children in each age group who are randomized to INL-001 will receive approximately less than
      or equal to 2.5 mg/kg of INL-001. Study drug will be administered prior to wound closure. The
      INL-001 implant will be cut before placement into the surgical site using sterile technique.
      Children randomized to 0.25% bupivacaine HCl injection will receive 2.5 mg/kg according to
      standard practice.

      After completion of the surgical procedure, all subjects will remain in the post-anesthesia
      care unit for at least 3 hours and will be continuously monitored for safety. At the
      discretion of the investigator, subjects may receive rescue medication (opioid or nonopioid)
      upon request for the management of breakthrough pain and may receive an antiemetic for the
      management of nausea or vomiting. After the initial 3-hour period, subjects who are deemed
      stable may be discharged to the hospital ward. Subjects will remain housed in the hospital
      ward for at least 48 hours. Blood samples will be collected for pharmacokinetic analysis from
      a subset of 8 children in each age group after INL-001 is implanted.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, controlled
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Participant, legal guardian and study personnel involved in the assessment of efficacy and safety are blinded to treatment.
measure: Adverse events
time frame: 30 days
description: Possibly related to bupivacaine toxicity
measure: Blood pressure (systolic/diastolic)
time frame: Starting at Time 0 and continuing for 3 hours and then 5, 8, 12, 24, 36, and 48 hours after Time 0
description: Signs/symptoms of bupivacaine toxicity
measure: Heart rate
time frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0
description: Signs/symptoms of bupivacaine toxicity
measure: Respiratory rate
time frame: Continuously from Time 0 through 3 hours, and then 5, 8, 12, 24, 36, and 48 hours after Time 0
description: Signs/symptoms of bupivacaine toxicity
measure: Body temperature
time frame: Through Day 30
description: Signs/symptoms of bupivacaine toxicity
measure: 12-lead ECG
time frame: 1 day at screening
description: Screening only
measure: 3-lead ECG
time frame: Starting at Time 0 and continuing for at least 3 hours
description: Signs/symptoms of bupivacaine toxicity
measure: Oxygen saturation levels
time frame: Starting at Time 0 and continuing for at least 3 hours
description: Pulse oximetry
measure: Clinical laboratory testing
time frame: 1 day at screening
description: Collection of blood and urine samples
measure: Wound healing assessments
time frame: Assessment on Day 1 through Day 3; follow-up evaluations on Days 7, 15 and 30
description: Inspection of surgical wound site for signs of wound infection and dehiscence.
measure: Nausea
time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
description: Measured using a categorical scoring system (none = 0, mild = 1, moderate = 2, and severe = 3). Nausea scores will also be recorded immediately before the use of rescue antiemetics
measure: Sedation
time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
description: Sedation scores: awake and alert = 0, quietly awake = 1, asleep but easily roused = 2, and deep sleep = 3.
measure: Cmax
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0.
description: Maximum observed plasma concentration
measure: AUC0-last
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
description: Area under the plasma concentration time curve from Time zero to last quantifiable plasma concentration
measure: AUC0-∞
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
description: Area under the plasma concentration time curve from Time zero to extrapolated through infinity
measure: Tmax
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
description: Time to maximum obserbved plasma concentration
measure: t1/2
time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hour time points after Time 0
description: Apparent first-order terminal elimination half-life
measure: Pain intensity
time frame: 1, 2, 4, 6, 12, 24, 36, and 48 hours after Time 0
description: Assessed using an 11-point NRS (for children 12 to <17 years of age), a FACES pain severity scale (children 4 through <12 years of age), or FLACC (children 2 and 3 years of age) immediately before the child receives any parenteral or oral rescue medication for breakthrough pain
arm group label: INL-001
arm group type: Experimental
description: Bupivacaine HCl collagen-matrix implant
arm group label: Infiltration
arm group type: Active Comparator
description: Bupivacaine HCl infiltration
intervention type: Drug
intervention name: Bupivacaine HCl collagen-matrix implant
description: Placement of the bupivacaine collagen-matrix in the surgical site
arm group label: INL-001
other name: Xaracoll
intervention type: Drug
intervention name: Bupivacaine HCl infiltration
description: Infiltration of the surgical site
arm group label: Infiltration
other name: Marcaine
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
last name: Gwendolyn Niebler, DO
role: Study Director
affiliation: Innocoll
last name: Nina Head of Clinical Operations
phone: 484-406-5214
email: rsmall@innocoll.com
last name: Nina Head of Clinical Research, MD
phone: 484-406-5205
email: nskuban@innocoll.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
country: United States
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Inguinal
mesh term: Bupivacaine
sharing ipd: No