<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/NCT03033589</url>
  </required_header>
  <id_info>
    <org_study_id>10083</org_study_id>
    <nct_id>NCT03033589</nct_id>
  </id_info>
  <brief_title>Femoral Nerve Block Versus Adductor Canal Nerve Block for Peri-Operative Analgesia Following Anterior Cruciate Ligament (ACL) Reconstruction: Evaluation of Post-operative Pain and Strength</brief_title>
  <official_title>Femoral Nerve Block Versus. Adductor Canal Nerve Block for Peri-Operative Analgesia Following Anterior Cruciate Ligament Reconstruction: Evaluation of Post-Operative Pain and Strength</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All patients over the age of 16 undergoing primary or revision anterior cruciate ligament&#xD;
      reconstruction with the use of bone-patellar-bone autograft are eligible for the study.&#xD;
      Patients will be randomized pre-operatively to receive either an adductor canal nerve block&#xD;
      (single injection) or a femoral nerve block (single injection). Post-operatively, the primary&#xD;
      outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic&#xD;
      analgesic requirements will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Currently, because of its good track record, femoral nerve block is the modality of choice&#xD;
      for post-operative pain control following elective anterior cruciate ligament reconstruction&#xD;
      at our institution. It has been proven in the literature to provide good post-operative pain&#xD;
      analgesia following this procedure (1). However, femoral nerve block is not without its&#xD;
      concerns, including the concern for long-term quadriceps weakness (2). Benefits of decreased&#xD;
      use of Femoral Nerve Block include the decreased incidence of side effects and/or&#xD;
      complications, and use of quadriceps for immediate rehabilitation. Benefits of Adductor canal&#xD;
      nerve block include possible equivalent pain control with the avoidance of motor&#xD;
      de-innervation and its deleterious adverse effect of quadriceps weakness postoperatively.&#xD;
      Adductor canal nerve block has proven to be effective in other orthopaedic procedures&#xD;
      involving the knee including total knee arthroplasty (3). This results of this study will&#xD;
      give more information on how to better control pain in the post-op period while minimizing&#xD;
      the deleterious side effects for patients undergoing ACLreconstruction.&#xD;
&#xD;
      All patients over the age of 16 undergoing primary or revision anterior cruciate ligament&#xD;
      reconstruction with the use of bone-patellar-bone autograft are eligible for the study.&#xD;
      Patients will be randomized pre-operatively to receive either an adductor canal nerve block&#xD;
      (single injection) or a femoral nerve block (single injection). A single dose of 30 mL of&#xD;
      0.25% marcaine is injected for femoral nerve block and 20 mL of 0.25% marcaine for Adductor&#xD;
      Canal nerve block. These procedures will be performed by the attending anesthesiologist prior&#xD;
      to surgery. After surgery the patient will record their pain levels using visual analog scale&#xD;
      (VAS) score in a daily diary for the first 5 post-operative days. They will also record all&#xD;
      medication requirements, both narcotic and non-narcotic analgesic medications. The patient&#xD;
      will be tested on their ability to perform a straight leg raise in the post-anesthesia care&#xD;
      unit (PACU) and at their first post-operative visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2017</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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>Post-op Day 0-5</time_frame>
    <description>Every 4 hours the patient will record in their study binder their pain level on a scale from 1-10. They are instructed that a 1 signifies minimal pain that is nearly unnoticeable whereas a pain scale of 10 is the most intolerable pain imaginable.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Narcotic Requirement</measure>
    <time_frame>Post-op Day 0-5</time_frame>
    <description>Every time a the prescribed narcotic is consumed, in this study it is Norco 5-325 (Hydrocodone-Acetaminophen), the subject is instructed to log their quantity consumed as well as the time consumed in the study binder provided to them</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thigh circumference</measure>
    <time_frame>2 weeks post-operative vs 6 months post-operative</time_frame>
    <description>Thigh circumference will be measured 10 cm above the superior pole of the patella for both the operative and non-operative thighs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Straight Leg Raise</measure>
    <time_frame>0-7 days post-operative</time_frame>
    <description>We will test the ability to perform straight leg raise in post-anesthesia care unit as well as at first post-operative visit (5-7 days post-operative).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Adductor Canal Nerve Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Femoral Nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Marcaine 0.25 % Injectable Solution</intervention_name>
    <description>For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area.</description>
    <arm_group_label>Adductor Canal Nerve Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Marcaine 0.25 % Injectable Solution</intervention_name>
    <description>For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area.</description>
    <arm_group_label>Femoral Nerve block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary ACL Reconstruction with use of Bone-Patellar-Bone Autograft&#xD;
&#xD;
          -  Age 16 or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 16&#xD;
&#xD;
          -  The use of Allograft,&#xD;
&#xD;
          -  The use of hamstring autograft&#xD;
&#xD;
          -  The use quadriceps autograft&#xD;
&#xD;
          -  Patients allergic to active ingredients in the injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jonathan R Lynch, MD</last_name>
    <phone>260-750-2494</phone>
    <email>jlynch6@hfhs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kelechi R Okoroha, MD</last_name>
    <phone>832-423-9895</phone>
    <email>kokoroh1@hfhs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Henry Ford Health System - CFP 642</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan R Lynch, MD</last_name>
      <phone>260-750-2494</phone>
      <email>jlynch6@hfhs.org</email>
    </contact>
    <contact_backup>
      <last_name>Kelechi Okoroha, MD</last_name>
      <phone>832-423-9895</phone>
      <email>kokoroh1@hfhs.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Guirro UB, Tambara EM, Munhoz FR. Femoral nerve block: Assessment of postoperative analgesia in arthroscopic anterior cruciate ligament reconstruction. Braz J Anesthesiol. 2013 Nov-Dec;63(6):483-91. doi: 10.1016/j.bjane.2013.09.001. Epub 2013 Dec 5.</citation>
    <PMID>24565346</PMID>
  </reference>
  <reference>
    <citation>Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med. 2015 Feb;43(2):331-6. doi: 10.1177/0363546514559823. Epub 2014 Dec 2.</citation>
    <PMID>25466410</PMID>
  </reference>
  <reference>
    <citation>Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.</citation>
    <PMID>24401769</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 24, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>January 26, 2017</last_update_submitted>
  <last_update_submitted_qc>January 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Jonathan Lynch</investigator_full_name>
    <investigator_title>Orthopaedic Surgery Resident</investigator_title>
  </responsible_party>
  <keyword>Pain control</keyword>
  <keyword>Anterior Cruciate Ligament (ACL_ Reconstruction)</keyword>
  <keyword>Regional Anesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03033589
org study id: 10083
nct id: NCT03033589
lead sponsor: 
has dmc: No
All patients over the age of 16 undergoing primary or revision anterior cruciate ligament
      reconstruction with the use of bone-patellar-bone autograft are eligible for the study.
      Patients will be randomized pre-operatively to receive either an adductor canal nerve block
      (single injection) or a femoral nerve block (single injection). Post-operatively, the primary
      outcome measures of pain level using visual analog scale as well as narcotic and non-narcotic
      analgesic requirements will be measured.
Currently, because of its good track record, femoral nerve block is the modality of choice
      for post-operative pain control following elective anterior cruciate ligament reconstruction
      at our institution. It has been proven in the literature to provide good post-operative pain
      analgesia following this procedure (1). However, femoral nerve block is not without its
      concerns, including the concern for long-term quadriceps weakness (2). Benefits of decreased
      use of Femoral Nerve Block include the decreased incidence of side effects and/or
      complications, and use of quadriceps for immediate rehabilitation. Benefits of Adductor canal
      nerve block include possible equivalent pain control with the avoidance of motor
      de-innervation and its deleterious adverse effect of quadriceps weakness postoperatively.
      Adductor canal nerve block has proven to be effective in other orthopaedic procedures
      involving the knee including total knee arthroplasty (3). This results of this study will
      give more information on how to better control pain in the post-op period while minimizing
      the deleterious side effects for patients undergoing ACLreconstruction.

      All patients over the age of 16 undergoing primary or revision anterior cruciate ligament
      reconstruction with the use of bone-patellar-bone autograft are eligible for the study.
      Patients will be randomized pre-operatively to receive either an adductor canal nerve block
      (single injection) or a femoral nerve block (single injection). A single dose of 30 mL of
      0.25% marcaine is injected for femoral nerve block and 20 mL of 0.25% marcaine for Adductor
      Canal nerve block. These procedures will be performed by the attending anesthesiologist prior
      to surgery. After surgery the patient will record their pain levels using visual analog scale
      (VAS) score in a daily diary for the first 5 post-operative days. They will also record all
      medication requirements, both narcotic and non-narcotic analgesic medications. The patient
      will be tested on their ability to perform a straight leg raise in the post-anesthesia care
      unit (PACU) and at their first post-operative visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Visual Analog Scale
time frame: Post-op Day 0-5
description: Every 4 hours the patient will record in their study binder their pain level on a scale from 1-10. They are instructed that a 1 signifies minimal pain that is nearly unnoticeable whereas a pain scale of 10 is the most intolerable pain imaginable.
measure: Narcotic Requirement
time frame: Post-op Day 0-5
description: Every time a the prescribed narcotic is consumed, in this study it is Norco 5-325 (Hydrocodone-Acetaminophen), the subject is instructed to log their quantity consumed as well as the time consumed in the study binder provided to them
measure: Thigh circumference
time frame: 2 weeks post-operative vs 6 months post-operative
description: Thigh circumference will be measured 10 cm above the superior pole of the patella for both the operative and non-operative thighs.
measure: Straight Leg Raise
time frame: 0-7 days post-operative
description: We will test the ability to perform straight leg raise in post-anesthesia care unit as well as at first post-operative visit (5-7 days post-operative).
arm group label: Adductor Canal Nerve Block
arm group type: Active Comparator
arm group label: Femoral Nerve block
arm group type: Active Comparator
intervention type: Drug
intervention name: Marcaine 0.25 % Injectable Solution
description: For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area.
arm group label: Adductor Canal Nerve Block
intervention type: Drug
intervention name: Marcaine 0.25 % Injectable Solution
description: For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area.
arm group label: Femoral Nerve block
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan R Lynch, MD
phone: 260-750-2494
email: jlynch6@hfhs.org
last name: Kelechi R Okoroha, MD
phone: 832-423-9895
email: kokoroh1@hfhs.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Guirro UB, Tambara EM, Munhoz FR. Femoral nerve block: Assessment of postoperative analgesia in arthroscopic anterior cruciate ligament reconstruction. Braz J Anesthesiol. 2013 Nov-Dec;63(6):483-91. doi: 10.1016/j.bjane.2013.09.001. Epub 2013 Dec 5.
PMID: 24565346
citation: Luo TD, Ashraf A, Dahm DL, Stuart MJ, McIntosh AL. Femoral nerve block is associated with persistent strength deficits at 6 months after anterior cruciate ligament reconstruction in pediatric and adolescent patients. Am J Sports Med. 2015 Feb;43(2):331-6. doi: 10.1177/0363546514559823. Epub 2014 Dec 2.
PMID: 25466410
citation: Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology. 2014 Mar;120(3):540-50. doi: 10.1097/ALN.0000000000000119.
PMID: 24401769
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Jonathan Lynch
investigator title: Orthopaedic Surgery Resident
mesh term: Pain, Postoperative
mesh term: Bupivacaine
mesh term: Pharmaceutical Solutions