xml: <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/NCT05985629</url>
    </required_header>
    <id_info>
      <org_study_id>LU 216180</org_study_id>
      <nct_id>NCT05985629</nct_id>
    </id_info>
    <brief_title>IPACK on Early Pain Scores After ACL Reconstruction</brief_title>
    <official_title>The Effect of IPACK Nerve Blocks on Early ACL Pain Scores</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Loyola University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Loyola University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to learn whether using an anesthetic technique called&#xD;
        IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  if participants who receive the IPACK block prior to ACL reconstruction experience less&#xD;
             pain after surgery and at 1 day after surgery&#xD;
  &#xD;
          -  if participants who receive the IPACK block prior to ACL reconstruction require less&#xD;
             short-term opioid use immediately after surgery and up to one week after surgery.&#xD;
  &#xD;
        Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL&#xD;
        reconstruction vs. placebo (a placebo is a look-alike substance that contains no active&#xD;
        drug). Neither the participant nor the investigator will know which group the participants&#xD;
        has been assigned to.&#xD;
  &#xD;
        Researchers will compare self-reported pain scores and short-term opioid use of all study&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Eligible patients will be approached for voluntary study participation after they have made&#xD;
        the decision to pursue an elective ACL reconstruction surgery with Dr. John Miller of Loyola&#xD;
        University Department of Orthopedic Surgery for management of their ACL tear.&#xD;
  &#xD;
        The study design is a double-blind, randomized trial. Patients will be randomly selected to&#xD;
        the control group or the treatment group. The groups will be randomized 1:1 using a block&#xD;
        method to be implemented. The control group will receive a sham block, while the treatment&#xD;
        group will receive the IPACK block. The use of a sham block, administered by the anesthesia&#xD;
        team, is to ensure that Dr. Miller is blinded to patient's treatment group. After&#xD;
        administration of the block and a completed ACL reconstruction surgery, pain scores will be&#xD;
        collected from the patient at two time points. First, pain scores will be collected in the&#xD;
        post-anesthesia care (PACU) unit using the visual analogue scale (VAS) immediately upon&#xD;
        waking up, one hour after waking up and upon discharge. Second, pain scores will be collected&#xD;
        during the standard post-operative follow-up phone call that Dr. Miller makes with all his&#xD;
        patients one day after surgery using the VAS pain scale. Short-term postoperative opioid&#xD;
        consumption will be measured in the PACU by calculating the milligram-equivalents of morphine&#xD;
        used by patients' starting at their arrival until their discharge. This data will be&#xD;
        extracted from the patient's chart on EPIC. Information about the patient's opioid use from&#xD;
        discharge until 1-week post-operatively will be collected either in person at the patient's&#xD;
        first outpatient post-operative follow up or via patient phone call one week after surgery&#xD;
        using a simple questionnaire&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 3, 2023</start_date>
    <completion_date type="Anticipated">August 3, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 3, 2025</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>An unblinded pharmacist will prepare the study drugs consisting of IPACK block, or the sham block consisting of saline (control group). All patients will be premedicated with midazolam, which is standard of care prior to general anesthesia. The use of a sham block, administered by the anesthesia team, is to ensure that the Investigator is blinded to patient's treatment group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Pain Scores</measure>
      <time_frame>Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery</time_frame>
      <description>Visual Analogue Scale (VAS). Participants self-report their post surgical pain from a scale of 0 to 10.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Opioid Consumption</measure>
      <time_frame>2-3 hours after surgery; 1 week after surgery</time_frame>
      <description>Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">78</enrollment>
    <condition>Pain, Postoperative</condition>
    <condition>Anterior Cruciate Ligament Injuries</condition>
    <condition>Analgesics, Opioid</condition>
    <arm_group>
      <arm_group_label>IPACK</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IPACK</intervention_name>
      <description>Infiltration between the popliteal artery and capsules of the knee (IPACK) is a novel ultrasound-guided technique that provides additional regional analgesic relief to the posterior aspect of the knee without complications seen in a sciatic nerve block. The intention of the IPACK block is to anesthetize the terminal sensory nerves while sparing the main trucks of the common peroneal and tibial nerves.</description>
      <arm_group_label>IPACK</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PLACEBO</intervention_name>
      <description>The control group will receive the normal pre-procedure care including a pre-operative visit, surgery, and post-operative care. The control group will receive a sham block consisting of saline in the same anatomical location and manner that the intervention IPACK block is administered.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients presenting to Dr. John Miller with the Department of Orthopedic Surgery,&#xD;
               Sports Medicine Division, at Loyola University Medical Center electing to undergo ACL&#xD;
               reconstruction surgery.&#xD;
  &#xD;
            -  Patients 16 and over&#xD;
  &#xD;
            -  English speaking patients&#xD;
  &#xD;
            -  Patients who have the capacity to make their own medical decisions and consent to the&#xD;
               study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous surgery on the operative knee&#xD;
  &#xD;
            -  Previous knee infection&#xD;
  &#xD;
            -  Chronic opioid use&#xD;
  &#xD;
            -  Have a known allergy to local anesthetics&#xD;
  &#xD;
            -  Patient using autograft (cadaver) for ACL reconstruction.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>John Miller, MD</last_name>
      <phone>708-216-8730</phone>
      <email>johnmiller@lumc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Loyola University Medical Center</name>
        <address>
          <city>Maywood</city>
          <state>Illinois</state>
          <zip>60153</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Susan Fargo, BA, CIP, CCRP</last_name>
        <phone>708-216-8046</phone>
        <email>sfargo@luc.edu</email>
      </contact>
      <investigator>
        <last_name>John Miller, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Scott Byram, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Anterior Cruciate Ligament Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>We do not have intentions on sharing IPD with other researchers at this time. If we decide to collaborate in the future, IPD will be de-identified prior to sharing.</ipd_description>
    </patient_data>
    <study_docs>
      <study_doc>
        <doc_type>Study Protocol</doc_type>
        <doc_url>https://hsd.luc.edu/cro/</doc_url>
        <doc_comment>Information about this study can be requested from the Clinical Research Office at Loyola University Chicago by calling 708-216-1153 or by mail at:&#xD;
  Loyola University Chicago Center for Translational Research and Education (CTRE) Bldg. 115, Suite 253, Rm 255 Maywood, IL 60153</doc_comment>
      </study_doc>
    </study_docs>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985629
  org study id: LU 216180
  nct id: NCT05985629
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to learn whether using an anesthetic technique called
        IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to
        answer are:
  
          -  if participants who receive the IPACK block prior to ACL reconstruction experience less
             pain after surgery and at 1 day after surgery
  
          -  if participants who receive the IPACK block prior to ACL reconstruction require less
             short-term opioid use immediately after surgery and up to one week after surgery.
  
        Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL
        reconstruction vs. placebo (a placebo is a look-alike substance that contains no active
        drug). Neither the participant nor the investigator will know which group the participants
        has been assigned to.
  
        Researchers will compare self-reported pain scores and short-term opioid use of all study
        participants.
  Eligible patients will be approached for voluntary study participation after they have made
        the decision to pursue an elective ACL reconstruction surgery with Dr. John Miller of Loyola
        University Department of Orthopedic Surgery for management of their ACL tear.
  
        The study design is a double-blind, randomized trial. Patients will be randomly selected to
        the control group or the treatment group. The groups will be randomized 1:1 using a block
        method to be implemented. The control group will receive a sham block, while the treatment
        group will receive the IPACK block. The use of a sham block, administered by the anesthesia
        team, is to ensure that Dr. Miller is blinded to patient's treatment group. After
        administration of the block and a completed ACL reconstruction surgery, pain scores will be
        collected from the patient at two time points. First, pain scores will be collected in the
        post-anesthesia care (PACU) unit using the visual analogue scale (VAS) immediately upon
        waking up, one hour after waking up and upon discharge. Second, pain scores will be collected
        during the standard post-operative follow-up phone call that Dr. Miller makes with all his
        patients one day after surgery using the VAS pain scale. Short-term postoperative opioid
        consumption will be measured in the PACU by calculating the milligram-equivalents of morphine
        used by patients' starting at their arrival until their discharge. This data will be
        extracted from the patient's chart on EPIC. Information about the patient's opioid use from
        discharge until 1-week post-operatively will be collected either in person at the patient's
        first outpatient post-operative follow up or via patient phone call one week after surgery
        using a simple questionnaire
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: An unblinded pharmacist will prepare the study drugs consisting of IPACK block, or the sham block consisting of saline (control group). All patients will be premedicated with midazolam, which is standard of care prior to general anesthesia. The use of a sham block, administered by the anesthesia team, is to ensure that the Investigator is blinded to patient's treatment group.
  measure: Pain Scores
  time frame: Immediately after surgery; 1 hour, 2-3 hours, and 24 hours after surgery
  description: Visual Analogue Scale (VAS). Participants self-report their post surgical pain from a scale of 0 to 10.
  measure: Opioid Consumption
  time frame: 2-3 hours after surgery; 1 week after surgery
  description: Short-term postoperative opioid consumption will be measured in the PACU by calculating the milligram-equivalents of morphine used by patients' starting at their arrival until their discharge. This data will be extracted from the patient's chart on EPIC. Information about the patient's opioid use from discharge until 1-week post-operatively will be collected either in person at the patient's first outpatient post-operative follow up or via patient phone call one week after surgery.
  arm group label: IPACK
  arm group type: Experimental
  description: After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected.
  intervention type: Drug
  intervention name: IPACK
  description: Infiltration between the popliteal artery and capsules of the knee (IPACK) is a novel ultrasound-guided technique that provides additional regional analgesic relief to the posterior aspect of the knee without complications seen in a sciatic nerve block. The intention of the IPACK block is to anesthetize the terminal sensory nerves while sparing the main trucks of the common peroneal and tibial nerves.
  arm group label: IPACK
  intervention type: Drug
  intervention name: PLACEBO
  description: The control group will receive the normal pre-procedure care including a pre-operative visit, surgery, and post-operative care. The control group will receive a sham block consisting of saline in the same anatomical location and manner that the intervention IPACK block is administered.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: John Miller, MD
  phone: 708-216-8730
  email: johnmiller@lumc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Anterior Cruciate Ligament Injuries
  sharing ipd: Undecided
  ipd description: We do not have intentions on sharing IPD with other researchers at this time. If we decide to collaborate in the future, IPD will be de-identified prior to sharing.
  study doc: 