<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/NCT03292926</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0934</org_study_id>
    <nct_id>NCT03292926</nct_id>
  </id_info>
  <brief_title>A Novel Analgesia Technique for ACL Reconstruction</brief_title>
  <official_title>A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <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>
      A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor&#xD;
      Canal Block with Infiltration of the interspace between the popliteal artery and the capsule&#xD;
      of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior&#xD;
      cruciate ligament (ACL) reconstruction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Actual">March 16, 2021</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain While at Rest</measure>
    <time_frame>24 hours post-block administration</time_frame>
    <description>Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Discharge Criteria</measure>
    <time_frame>From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day</time_frame>
    <description>Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain With Ambulation</measure>
    <time_frame>3 hours post-block administration on Post-operative day (POD) 0</time_frame>
    <description>NRS Pain score with ambulation &amp; stairs. A lower score is a better outcome. Score range is from 0 to 10.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Anterior Cruciate Ligament Injury</condition>
  <arm_group>
    <arm_group_label>Adductor Canal Block (ACB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adductor Canal Block &amp; IPACK (ACB/IPACK)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Bupivacaine will help treat pain and sensation after ACL repair</description>
    <arm_group_label>Adductor Canal Block &amp; IPACK (ACB/IPACK)</arm_group_label>
    <arm_group_label>Adductor Canal Block (ACB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound will guide anesthesiologist in performing the different nerve blocks</description>
    <arm_group_label>Adductor Canal Block &amp; IPACK (ACB/IPACK)</arm_group_label>
    <arm_group_label>Adductor Canal Block (ACB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone will be used to prolong block duration</description>
    <arm_group_label>Adductor Canal Block &amp; IPACK (ACB/IPACK)</arm_group_label>
    <arm_group_label>Adductor Canal Block (ACB)</arm_group_label>
    <other_name>preservative free Dexamethasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing BTB ACL reconstruction with participating surgeon&#xD;
&#xD;
          -  Age 13 or greater&#xD;
&#xD;
          -  Planned use of regional anesthesia&#xD;
&#xD;
          -  Ability to follow study protocol&#xD;
&#xD;
          -  English speaking (secondary outcomes include questionnaires validated in English only)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatic or renal insufficiency&#xD;
&#xD;
          -  Younger than 13 years old&#xD;
&#xD;
          -  Patients undergoing general anesthesia&#xD;
&#xD;
          -  Allergy or intolerance to one of the study medications&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  American Society of Anesthesiology (ASA) score IV&#xD;
&#xD;
          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)&#xD;
&#xD;
          -  Chronic opioid use (taking opioids for longer than 3 months, or daily morphine&#xD;
             equivalent of &gt;5mg/day for one month)&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Beathe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>April 12, 2022</results_first_submitted>
  <results_first_submitted_qc>May 10, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2022</results_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 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>Anterior Cruciate Ligament Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>July 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03292926/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Adductor Canal Block (ACB)</title>
          <description>The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
        </group>
        <group group_id="P2">
          <title>Adductor Canal Block &amp; IPACK (ACB/IPACK)</title>
          <description>The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="39"/>
              </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>Adductor Canal Block (ACB)</title>
          <description>The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
        </group>
        <group group_id="B2">
          <title>Adductor Canal Block &amp; IPACK (ACB/IPACK)</title>
          <description>The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</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="39"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="78"/>
          </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="23" spread="7"/>
                    <measurement group_id="B2" value="25" spread="8"/>
                    <measurement group_id="B3" value="24" spread="7"/>
                  </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="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain While at Rest</title>
        <description>Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.</description>
        <time_frame>24 hours post-block administration</time_frame>
        <population>some patients were lost to follow up</population>
        <group_list>
          <group group_id="O1">
            <title>Adductor Canal Block (ACB)</title>
            <description>The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
          </group>
          <group group_id="O2">
            <title>Adductor Canal Block &amp; IPACK (ACB/IPACK)</title>
            <description>The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
          </group>
        </group_list>
        <measure>
          <title>Pain While at Rest</title>
          <description>Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.</description>
          <population>some patients were lost to follow up</population>
          <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="37"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.84" spread="1.86"/>
                    <measurement group_id="O2" value="3.95" spread="2.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Discharge Criteria</title>
        <description>Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.</description>
        <time_frame>From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day</time_frame>
        <population>some patients lost to follow up</population>
        <group_list>
          <group group_id="O1">
            <title>Adductor Canal Block (ACB)</title>
            <description>The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
          </group>
          <group group_id="O2">
            <title>Adductor Canal Block &amp; IPACK (ACB/IPACK)</title>
            <description>The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
          </group>
        </group_list>
        <measure>
          <title>Discharge Criteria</title>
          <description>Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.</description>
          <population>some patients lost to follow up</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="39"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180.67" spread="143.84"/>
                    <measurement group_id="O2" value="189.92" spread="254.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain With Ambulation</title>
        <description>NRS Pain score with ambulation &amp; stairs. A lower score is a better outcome. Score range is from 0 to 10.</description>
        <time_frame>3 hours post-block administration on Post-operative day (POD) 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Adductor Canal Block (ACB)</title>
            <description>The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
          </group>
          <group group_id="O2">
            <title>Adductor Canal Block &amp; IPACK (ACB/IPACK)</title>
            <description>The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
          </group>
        </group_list>
        <measure>
          <title>Pain With Ambulation</title>
          <description>NRS Pain score with ambulation &amp; stairs. A lower score is a better outcome. Score range is from 0 to 10.</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="39"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>NRS with Ambulation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.59" spread="1.43"/>
                    <measurement group_id="O2" value="1.26" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRS with Stairs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.05" spread="1.92"/>
                    <measurement group_id="O2" value="2.1" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 7 days after surgery</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Adductor Canal Block (ACB)</title>
          <description>The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
        </group>
        <group group_id="E2">
          <title>Adductor Canal Block &amp; IPACK (ACB/IPACK)</title>
          <description>The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.&#xD;
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.&#xD;
Bupivacaine: Bupivacaine will help treat pain and sensation after ACL repair&#xD;
Ultrasound: Ultrasound will guide anesthesiologist in performing the different nerve blocks&#xD;
Dexamethasone: Dexamethasone will be used to prolong block duration</description>
        </group>
      </group_list>
      <serious_events>
        <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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </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="39"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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. Jonathan Beathe</name_or_title>
      <organization>Hospital for Special Surgery, Anesthesiology</organization>
      <phone>2126061036</phone>
      <email>beatheJ@hss.edu</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/NCT03292926
org study id: 2017-0934
nct id: NCT03292926
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
A comparison of two anesthetic techniques-- the Adductor Canal Block (ACB) and the Adductor
      Canal Block with Infiltration of the interspace between the popliteal artery and the capsule
      of the posterior knee (ACB/IPACK)-- in patients undergoing bone-tendon-bone (BTB) anterior
      cruciate ligament (ACL) reconstruction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Pain While at Rest
time frame: 24 hours post-block administration
description: Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10.
measure: Discharge Criteria
time frame: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
description: Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin.
measure: Pain With Ambulation
time frame: 3 hours post-block administration on Post-operative day (POD) 0
description: NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10.
arm group label: Adductor Canal Block (ACB)
arm group type: Active Comparator
description: The adductor canal block will be ultrasound-guided sonosite. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22 gauge (G)/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
arm group label: Adductor Canal Block & IPACK (ACB/IPACK)
arm group type: Active Comparator
description: The adductor canal block will be ultrasound-guided. The anesthesiologist will administer 15 cc bupivacaine 0.5% with 2 mg preservative-free dexamethasone with a 22G/4 inch Chiba needle to the mid-thigh of the surgical limb while subject lays in the supine position post IV sedation.
The IPACK will be ultrasound-guided with c60 sonosite probe (5-2Hz). While laying in the prone or supine, frog-leg position the IPACK will be administered using a 22G/4inch Chiba needle. The anesthesiologist will identify the popliteal artery at the popliteal crease and move cephalad just beyond the femoral condyles at the confluence with the femur. Then the anesthesiologist will identify the space between the femur and the popliteal artery and moving from medial to lateral place the needle in between the popliteal artery and femur with the tip ending 2-3 cm lateral to the artery and inject 25 cc bupivacaine 0.25% with 2 mg preservative-free dexamethasone.
intervention type: Drug
intervention name: Bupivacaine
description: Bupivacaine will help treat pain and sensation after ACL repair
arm group label: Adductor Canal Block & IPACK (ACB/IPACK)
arm group label: Adductor Canal Block (ACB)
intervention type: Device
intervention name: Ultrasound
description: Ultrasound will guide anesthesiologist in performing the different nerve blocks
arm group label: Adductor Canal Block & IPACK (ACB/IPACK)
arm group label: Adductor Canal Block (ACB)
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone will be used to prolong block duration
arm group label: Adductor Canal Block & IPACK (ACB/IPACK)
arm group label: Adductor Canal Block (ACB)
other name: preservative free Dexamethasone
criteria: 
gender: All
minimum age: 13 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jonathan Beathe, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anterior Cruciate Ligament Injuries
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Bupivacaine
mesh term: BB 1101
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 