<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/NCT03303794</url>
  </required_header>
  <id_info>
    <org_study_id>2017-7893</org_study_id>
    <nct_id>NCT03303794</nct_id>
  </id_info>
  <brief_title>0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka</brief_title>
  <official_title>Comparative Feasibility and Efficacy of a Five Compartment Technique Using 0.25% Bupivacaine vs a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka; a Single Blinded Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total knee and hip replacements are some of the most common orthopedic procedures that&#xD;
      require aggressive postoperative pain management. This management helps us to improve&#xD;
      clinical outcomes such as participation in early physical therapy, hospital discharge, and&#xD;
      patient satisfaction. Based on the recent anatomical evidence and the investigator's&#xD;
      knowledge of the complexity of the knee joint innervation the investigator proposes a new&#xD;
      regional anesthesia technique that provides a complete sensory blockade and better analgesia&#xD;
      while preserving the quadriceps strength and avoiding the potential for foot drop caused by&#xD;
      inadvertent blockade of the common peroneal nerve.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal&#xD;
      bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of&#xD;
      this study is the proportion of patients &quot;fit to discharge&quot; on postoperative day one.&#xD;
      Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a&#xD;
      lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel)&#xD;
      uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been&#xD;
      used in clinical practice for decades for peripheral nerve block, spinal, and epidural&#xD;
      analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine&#xD;
      for up to 72 hours with a single injection. The study was designed to compare two of our&#xD;
      current standard therapies:&#xD;
&#xD;
        1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment +&#xD;
           posterior capsule tissue infiltration using 0.25% bupivacaine; and&#xD;
&#xD;
        2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment +&#xD;
           posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5%&#xD;
           bupivacaine HCl mixture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Interim Analysis showed no significance&#xD;
  </why_stopped>
  <start_date type="Actual">October 25, 2017</start_date>
  <completion_date type="Actual">June 27, 2018</completion_date>
  <primary_completion_date type="Actual">June 27, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AM-PAC Score to Measure Patients Fitness for Discharge</measure>
    <time_frame>Post-Operation Day 1</time_frame>
    <description>AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption During the First 48 Hours After TKA Surgery</measure>
    <time_frame>During the first 48 hours after surgery</time_frame>
    <description>Monitor how much opioid patient consumes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores During 48 Hrs Postoperatively</measure>
    <time_frame>48 hours postoperatively</time_frame>
    <description>Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Bupivicaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivicaine + Exparel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel</intervention_name>
    <description>1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty</description>
    <arm_group_label>Bupivicaine + Exparel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.25% bupivacaine</intervention_name>
    <description>0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
    <arm_group_label>Bupivicaine</arm_group_label>
    <arm_group_label>Bupivicaine + Exparel</arm_group_label>
    <other_name>liposomal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing unilateral total knee replacement due to OA or rheumatoid&#xD;
             arthritis&#xD;
&#xD;
          -  Ages 40- 80 years old&#xD;
&#xD;
          -  American Society of Anesthesiologists class I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal or absolute medical contraindication to peripheral nerve block&#xD;
&#xD;
          -  refusal or absolute medical contraindication to spinal anesthesia&#xD;
&#xD;
          -  conversion of spinal anesthesia to general anesthesia is obtained&#xD;
&#xD;
          -  inability to cooperate&#xD;
&#xD;
          -  allergy to any drug used in this study&#xD;
&#xD;
          -  daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)&#xD;
&#xD;
          -  alcohol dependence or use of any illegal drugs within the last month&#xD;
&#xD;
          -  inability to perform the mobilization test and timed up and go (TUG) test&#xD;
             pre-operatively&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boleslav Kosharskyy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Hutchinson Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major orthopaedic surgery with peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):518-28. doi: 10.1093/bja/aet013. Epub 2013 Feb 24.</citation>
    <PMID>23440367</PMID>
  </reference>
  <reference>
    <citation>Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.</citation>
    <PMID>19258965</PMID>
  </reference>
  <reference>
    <citation>Hebl JR, Kopp SL, Ali MH, Horlocker TT, Dilger JA, Lennon RL, Williams BA, Hanssen AD, Pagnano MW. A comprehensive anesthesia protocol that emphasizes peripheral nerve blockade for total knee and total hip arthroplasty. J Bone Joint Surg Am. 2005;87 Suppl 2:63-70. doi: 10.2106/JBJS.E.00491. No abstract available.</citation>
    <PMID>16326725</PMID>
  </reference>
  <reference>
    <citation>Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.</citation>
    <PMID>18362603</PMID>
  </reference>
  <reference>
    <citation>Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.</citation>
    <PMID>19553071</PMID>
  </reference>
  <reference>
    <citation>Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.</citation>
    <PMID>18719448</PMID>
  </reference>
  <reference>
    <citation>Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.</citation>
    <PMID>20889937</PMID>
  </reference>
  <reference>
    <citation>Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.</citation>
    <PMID>19046884</PMID>
  </reference>
  <reference>
    <citation>Klein SM, Nielsen KC, Greengrass RA, Warner DS, Martin A, Steele SM. Ambulatory discharge after long-acting peripheral nerve blockade: 2382 blocks with ropivacaine. Anesth Analg. 2002 Jan;94(1):65-70, table of contents. doi: 10.1097/00000539-200201000-00012.</citation>
    <PMID>11772802</PMID>
  </reference>
  <reference>
    <citation>Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.</citation>
    <PMID>17196495</PMID>
  </reference>
  <reference>
    <citation>Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.</citation>
    <PMID>19680735</PMID>
  </reference>
  <reference>
    <citation>Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. Anesth Analg. 2007 Apr;104(4):1002. doi: 10.1213/01.ane.0000256006.46703.7f. No abstract available.</citation>
    <PMID>17377133</PMID>
  </reference>
  <reference>
    <citation>Church S, Robinson TN, Angles EM, Tran ZV, Wallace JI. Postoperative falls in the acute hospital setting: characteristics, risk factors, and outcomes in males. Am J Surg. 2011 Feb;201(2):197-202. doi: 10.1016/j.amjsurg.2009.12.013. Epub 2010 Sep 18.</citation>
    <PMID>20851375</PMID>
  </reference>
  <reference>
    <citation>Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.</citation>
    <PMID>21039357</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>
  <reference>
    <citation>Kennedy JC, Alexander IJ, Hayes KC. Nerve supply of the human knee and its functional importance. Am J Sports Med. 1982 Nov-Dec;10(6):329-35. doi: 10.1177/036354658201000601.</citation>
    <PMID>6897495</PMID>
  </reference>
  <reference>
    <citation>Franco CD, Buvanendran A, Petersohn JD, Menzies RD, Menzies LP. Innervation of the Anterior Capsule of the Human Knee: Implications for Radiofrequency Ablation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):363-8. doi: 10.1097/AAP.0000000000000269.</citation>
    <PMID>26066383</PMID>
  </reference>
  <reference>
    <citation>Krenzel BA, Cook C, Martin GN, Vail TP, Attarian DE, Bolognesi MP. Posterior capsular injections of ropivacaine during total knee arthroplasty: a randomized, double-blind, placebo-controlled study. J Arthroplasty. 2009 Sep;24(6 Suppl):138-43. doi: 10.1016/j.arth.2009.03.014. Epub 2009 Jun 10.</citation>
    <PMID>19520544</PMID>
  </reference>
  <reference>
    <citation>C. Vlessides M. New Regional Technique Controls Post-TKA Pain. Anesthesiology News. December 2012.</citation>
  </reference>
  <reference>
    <citation>Egeler C, Jayakumar A, Ford S. Motor-sparing knee block - description of a new technique. Anaesthesia. 2013 May;68(5):542-3. doi: 10.1111/anae.12233. No abstract available.</citation>
    <PMID>23573861</PMID>
  </reference>
  <reference>
    <citation>Mantripragada S. A lipid based depot (DepoFoam technology) for sustained release drug delivery. Prog Lipid Res. 2002 Sep;41(5):392-406. doi: 10.1016/s0163-7827(02)00004-8.</citation>
    <PMID>12121719</PMID>
  </reference>
  <reference>
    <citation>Richard BM, Newton P, Ott LR, Haan D, Brubaker AN, Cole PI, Ross PE, Rebelatto MC, Nelson KG. The Safety of EXPAREL (R) (Bupivacaine Liposome Injectable Suspension) Administered by Peripheral Nerve Block in Rabbits and Dogs. J Drug Deliv. 2012;2012:962101. doi: 10.1155/2012/962101. Epub 2012 Jan 17.</citation>
    <PMID>22363842</PMID>
  </reference>
  <reference>
    <citation>Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12.</citation>
    <PMID>21842428</PMID>
  </reference>
  <reference>
    <citation>Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.</citation>
    <PMID>22546131</PMID>
  </reference>
  <reference>
    <citation>Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.</citation>
    <PMID>22067185</PMID>
  </reference>
  <reference>
    <citation>Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.</citation>
    <PMID>22570563</PMID>
  </reference>
  <reference>
    <citation>Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.</citation>
    <PMID>26204387</PMID>
  </reference>
  <reference>
    <citation>Emerson RH Jr, Barrington JW, Olugbode O, Lovald S, Watson H, Ong K. Femoral Nerve Block Versus Long-Acting Wound Infiltration in Total Knee Arthroplasty. Orthopedics. 2016 May 1;39(3):e449-55. doi: 10.3928/01477447-20160315-03. Epub 2016 Mar 29.</citation>
    <PMID>27018607</PMID>
  </reference>
  <reference>
    <citation>Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.</citation>
    <PMID>21856077</PMID>
  </reference>
  <reference>
    <citation>Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.</citation>
    <PMID>16000093</PMID>
  </reference>
  <reference>
    <citation>Haley SM, Coster WJ, Andres PL, Ludlow LH, Ni P, Bond TL, Sinclair SJ, Jette AM. Activity outcome measurement for postacute care. Med Care. 2004 Jan;42(1 Suppl):I49-61. doi: 10.1097/01.mlr.0000103520.43902.6c.</citation>
    <PMID>14707755</PMID>
  </reference>
  <reference>
    <citation>Jette DU, Stilphen M, Ranganathan VK, Passek SD, Frost FS, Jette AM. AM-PAC &quot;6-Clicks&quot; functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014 Sep;94(9):1252-61. doi: 10.2522/ptj.20130359. Epub 2014 Apr 24.</citation>
    <PMID>24764073</PMID>
  </reference>
  <reference>
    <citation>Menendez ME, Schumacher CS, Ring D, Freiberg AA, Rubash HE, Kwon YM. Does &quot;6-Clicks&quot; Day 1 Postoperative Mobility Score Predict Discharge Disposition After Total Hip and Knee Arthroplasties? J Arthroplasty. 2016 Sep;31(9):1916-20. doi: 10.1016/j.arth.2016.02.017. Epub 2016 Feb 17.</citation>
    <PMID>26993155</PMID>
  </reference>
  <reference>
    <citation>Bickler P, Brandes J, Lee M, Bozic K, Chesbro B, Claassen J. Bleeding complications from femoral and sciatic nerve catheters in patients receiving low molecular weight heparin. Anesth Analg. 2006 Oct;103(4):1036-7. doi: 10.1213/01.ane.0000237230.40246.44.</citation>
    <PMID>17000826</PMID>
  </reference>
  <reference>
    <citation>Buckenmaier CC 3rd, Shields CH, Auton AA, Evans SL, Croll SM, Bleckner LL, Brown DS, Stojadinovic A. Continuous peripheral nerve block in combat casualties receiving low-molecular weight heparin. Br J Anaesth. 2006 Dec;97(6):874-7. doi: 10.1093/bja/ael269. Epub 2006 Oct 9.</citation>
    <PMID>17032662</PMID>
  </reference>
  <reference>
    <citation>Idestrup C, Sawhney M, Nix C, Kiss A. The incidence of hematoma formation in patients with continuous femoral catheters following total knee arthroplasty while receiving rivaroxaban as thromboprophylaxis: an observational study. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):414-7. doi: 10.1097/AAP.0000000000000127.</citation>
    <PMID>25102065</PMID>
  </reference>
  <reference>
    <citation>Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec.</citation>
    <PMID>17377115</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>January 21, 2020</results_first_submitted>
  <results_first_submitted_qc>March 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2020</results_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Singh Nair</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Total Knee arthroplasty</keyword>
  <keyword>bupivacaine</keyword>
  <keyword>anesthesia</keyword>
  <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>
    <ipd_description>All study data will be collected and entered into the computer database. Each subject will be assigned to a random number code and the key linking the code and the subject identifier will be stored in a locked cabinet. The computer database will be password protected and will be kept on the Montefiore drive. The research manager is responsible for auditing the consistency of the data transcribed from the paper case report form to the computer. A protocol violation log will be maintained and all protocol violations will be reported to the Institutional Review Board and Data Safety Monitoring Board. The planned interim analysis (half way through the recruitment) will be mainly focused on the adverse events, rather than the efficacy of the procedure.</ipd_description>
  </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>October 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03303794/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bupivicaine</title>
          <description>0.25% bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
        </group>
        <group group_id="P2">
          <title>Bupivicaine + Exparel</title>
          <description>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </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>Bupivicaine</title>
          <description>0.25% bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
        </group>
        <group group_id="B2">
          <title>Bupivicaine + Exparel</title>
          <description>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</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="13"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" lower_limit="66" upper_limit="75"/>
                    <measurement group_id="B2" value="67" lower_limit="58" upper_limit="77"/>
                    <measurement group_id="B3" value="70" lower_limit="63" upper_limit="75"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="13"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>AM-PAC Score to Measure Patients Fitness for Discharge</title>
        <description>AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.</description>
        <time_frame>Post-Operation Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivicaine</title>
            <description>0.25% bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
          </group>
          <group group_id="O2">
            <title>Bupivicaine + Exparel</title>
            <description>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
          </group>
        </group_list>
        <measure>
          <title>AM-PAC Score to Measure Patients Fitness for Discharge</title>
          <description>AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="19" upper_limit="23"/>
                    <measurement group_id="O2" value="23" lower_limit="21" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption During the First 48 Hours After TKA Surgery</title>
        <description>Monitor how much opioid patient consumes</description>
        <time_frame>During the first 48 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivicaine</title>
            <description>0.25% bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
          </group>
          <group group_id="O2">
            <title>Bupivicaine + Exparel</title>
            <description>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption During the First 48 Hours After TKA Surgery</title>
          <description>Monitor how much opioid patient consumes</description>
          <units>milligram</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="39" upper_limit="118"/>
                    <measurement group_id="O2" value="76" lower_limit="25" upper_limit="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Scores During 48 Hrs Postoperatively</title>
        <description>Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.</description>
        <time_frame>48 hours postoperatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivicaine</title>
            <description>0.25% bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
          </group>
          <group group_id="O2">
            <title>Bupivicaine + Exparel</title>
            <description>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores During 48 Hrs Postoperatively</title>
          <description>Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.</description>
          <units>score on scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2.5" upper_limit="7"/>
                    <measurement group_id="O2" value="4" lower_limit="3" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected up until 48 hours post operation.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Bupivicaine</title>
          <description>0.25% bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</description>
        </group>
        <group group_id="E2">
          <title>Bupivicaine + Exparel</title>
          <description>0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
Exparel: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty&#xD;
0.25% bupivacaine: 0.25% bupivacaine in patients undergoing total knee arthroplasty</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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </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.Singh Nair</name_or_title>
      <organization>Montefiore Medical Center</organization>
      <phone>7189205932</phone>
      <email>sinair@montefiore.org</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/NCT03303794
org study id: 2017-7893
nct id: NCT03303794
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Total knee and hip replacements are some of the most common orthopedic procedures that
      require aggressive postoperative pain management. This management helps us to improve
      clinical outcomes such as participation in early physical therapy, hospital discharge, and
      patient satisfaction. Based on the recent anatomical evidence and the investigator's
      knowledge of the complexity of the knee joint innervation the investigator proposes a new
      regional anesthesia technique that provides a complete sensory blockade and better analgesia
      while preserving the quadriceps strength and avoiding the potential for foot drop caused by
      inadvertent blockade of the common peroneal nerve.
This is an assessor-blinded randomized controlled trial evaluating the efficacy of liposomal
      bupivacaine (Exparel) in patients undergoing Total Knee Arthroplasty. The primary outcome of
      this study is the proportion of patients "fit to discharge" on postoperative day one.
      Recently, liposomal bupivacaine (LB) (Exparel) was introduced into clinical practice, using a
      lipid-based depot (DepoFoam) technology for sustained release of bupivacaine. LB (Exparel)
      uses this technology to extend the delivery of bupivacaine, a local anesthetic that has been
      used in clinical practice for decades for peripheral nerve block, spinal, and epidural
      analgesia and anesthesia. This formulation prolongs the duration of analgesia of bupivacaine
      for up to 72 hours with a single injection. The study was designed to compare two of our
      current standard therapies:

        1. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment +
           posterior capsule tissue infiltration using 0.25% bupivacaine; and

        2. Adductor Canal Block + Tissue Infiltration (lateral, medial and femoral compartment +
           posterior capsule tissue infiltration) using 1:1 mixture of 1.3% LB (Exparel) + 0.5%
           bupivacaine HCl mixture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: AM-PAC Score to Measure Patients Fitness for Discharge
time frame: Post-Operation Day 1
description: AM-PAC (activity measure for post-acute care) will be used to determine if a patient is fit to discharge based on mobility with 6 being unable to mobilize up to 24 being independent. Patients who scored above 20 were considered fit to discharge.
measure: Opioid Consumption During the First 48 Hours After TKA Surgery
time frame: During the first 48 hours after surgery
description: Monitor how much opioid patient consumes
measure: Pain Scores During 48 Hrs Postoperatively
time frame: 48 hours postoperatively
description: Will use Numeric Pain Rating Scale (NPRS) to measure pain with 0 being no pain and 10 being the worst pain.
arm group label: Bupivicaine
arm group type: Active Comparator
description: 0.25% bupivacaine in patients undergoing total knee arthroplasty
arm group label: Bupivicaine + Exparel
arm group type: Experimental
description: 0.25% bupivacaine and 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
intervention type: Drug
intervention name: Exparel
description: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
arm group label: Bupivicaine + Exparel
intervention type: Drug
intervention name: 0.25% bupivacaine
description: 0.25% bupivacaine in patients undergoing total knee arthroplasty
arm group label: Bupivicaine
arm group label: Bupivicaine + Exparel
other name: liposomal
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Boleslav Kosharskyy, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
facility: 
country: United States
citation: Johnson RL, Kopp SL, Hebl JR, Erwin PJ, Mantilla CB. Falls and major orthopaedic surgery with peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):518-28. doi: 10.1093/bja/aet013. Epub 2013 Feb 24.
PMID: 23440367
citation: Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.
PMID: 19258965
citation: Hebl JR, Kopp SL, Ali MH, Horlocker TT, Dilger JA, Lennon RL, Williams BA, Hanssen AD, Pagnano MW. A comprehensive anesthesia protocol that emphasizes peripheral nerve blockade for total knee and total hip arthroplasty. J Bone Joint Surg Am. 2005;87 Suppl 2:63-70. doi: 10.2106/JBJS.E.00491. No abstract available.
PMID: 16326725
citation: Ilfeld BM, Le LT, Meyer RS, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Berry LF, Spadoni EH, Gearen PF. Ambulatory continuous femoral nerve blocks decrease time to discharge readiness after tricompartment total knee arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2008 Apr;108(4):703-13. doi: 10.1097/ALN.0b013e318167af46.
PMID: 18362603
citation: Feibel RJ, Dervin GF, Kim PR, Beaule PE. Major complications associated with femoral nerve catheters for knee arthroplasty: a word of caution. J Arthroplasty. 2009 Sep;24(6 Suppl):132-7. doi: 10.1016/j.arth.2009.04.008. Epub 2009 Jun 24.
PMID: 19553071
citation: Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.
PMID: 18719448
citation: Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
PMID: 20889937
citation: Kandasami M, Kinninmonth AW, Sarungi M, Baines J, Scott NB. Femoral nerve block for total knee replacement - a word of caution. Knee. 2009 Mar;16(2):98-100. doi: 10.1016/j.knee.2008.10.007. Epub 2008 Nov 28.
PMID: 19046884
citation: Klein SM, Nielsen KC, Greengrass RA, Warner DS, Martin A, Steele SM. Ambulatory discharge after long-acting peripheral nerve blockade: 2382 blocks with ropivacaine. Anesth Analg. 2002 Jan;94(1):65-70, table of contents. doi: 10.1097/00000539-200201000-00012.
PMID: 11772802
citation: Muraskin SI, Conrad B, Zheng N, Morey TE, Enneking FK. Falls associated with lower-extremity-nerve blocks: a pilot investigation of mechanisms. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):67-72. doi: 10.1016/j.rapm.2006.08.013.
PMID: 17196495
citation: Sharma S, Iorio R, Specht LM, Davies-Lepie S, Healy WL. Complications of femoral nerve block for total knee arthroplasty. Clin Orthop Relat Res. 2010 Jan;468(1):135-40. doi: 10.1007/s11999-009-1025-1. Epub 2009 Aug 13.
PMID: 19680735
citation: Williams BA, Kentor ML, Bottegal MT. The incidence of falls at home in patients with perineural femoral catheters: a retrospective summary of a randomized clinical trial. Anesth Analg. 2007 Apr;104(4):1002. doi: 10.1213/01.ane.0000256006.46703.7f. No abstract available.
PMID: 17377133
citation: Church S, Robinson TN, Angles EM, Tran ZV, Wallace JI. Postoperative falls in the acute hospital setting: characteristics, risk factors, and outcomes in males. Am J Surg. 2011 Feb;201(2):197-202. doi: 10.1016/j.amjsurg.2009.12.013. Epub 2010 Sep 18.
PMID: 20851375
citation: Lund J, Jenstrup MT, Jaeger P, Sorensen AM, Dahl JB. Continuous adductor-canal-blockade for adjuvant post-operative analgesia after major knee surgery: preliminary results. Acta Anaesthesiol Scand. 2011 Jan;55(1):14-9. doi: 10.1111/j.1399-6576.2010.02333.x. Epub 2010 Oct 29.
PMID: 21039357
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
citation: Kennedy JC, Alexander IJ, Hayes KC. Nerve supply of the human knee and its functional importance. Am J Sports Med. 1982 Nov-Dec;10(6):329-35. doi: 10.1177/036354658201000601.
PMID: 6897495
citation: Franco CD, Buvanendran A, Petersohn JD, Menzies RD, Menzies LP. Innervation of the Anterior Capsule of the Human Knee: Implications for Radiofrequency Ablation. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):363-8. doi: 10.1097/AAP.0000000000000269.
PMID: 26066383
citation: Krenzel BA, Cook C, Martin GN, Vail TP, Attarian DE, Bolognesi MP. Posterior capsular injections of ropivacaine during total knee arthroplasty: a randomized, double-blind, placebo-controlled study. J Arthroplasty. 2009 Sep;24(6 Suppl):138-43. doi: 10.1016/j.arth.2009.03.014. Epub 2009 Jun 10.
PMID: 19520544
citation: C. Vlessides M. New Regional Technique Controls Post-TKA Pain. Anesthesiology News. December 2012.
citation: Egeler C, Jayakumar A, Ford S. Motor-sparing knee block - description of a new technique. Anaesthesia. 2013 May;68(5):542-3. doi: 10.1111/anae.12233. No abstract available.
PMID: 23573861
citation: Mantripragada S. A lipid based depot (DepoFoam technology) for sustained release drug delivery. Prog Lipid Res. 2002 Sep;41(5):392-406. doi: 10.1016/s0163-7827(02)00004-8.
PMID: 12121719
citation: Richard BM, Newton P, Ott LR, Haan D, Brubaker AN, Cole PI, Ross PE, Rebelatto MC, Nelson KG. The Safety of EXPAREL (R) (Bupivacaine Liposome Injectable Suspension) Administered by Peripheral Nerve Block in Rabbits and Dogs. J Drug Deliv. 2012;2012:962101. doi: 10.1155/2012/962101. Epub 2012 Jan 17.
PMID: 22363842
citation: Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12.
PMID: 21842428
citation: Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.
PMID: 22546131
citation: Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
PMID: 22067185
citation: Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
PMID: 22570563
citation: Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
PMID: 26204387
citation: Emerson RH Jr, Barrington JW, Olugbode O, Lovald S, Watson H, Ong K. Femoral Nerve Block Versus Long-Acting Wound Infiltration in Total Knee Arthroplasty. Orthopedics. 2016 May 1;39(3):e449-55. doi: 10.3928/01477447-20160315-03. Epub 2016 Mar 29.
PMID: 27018607
citation: Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PMID: 21856077
citation: Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
PMID: 16000093
citation: Haley SM, Coster WJ, Andres PL, Ludlow LH, Ni P, Bond TL, Sinclair SJ, Jette AM. Activity outcome measurement for postacute care. Med Care. 2004 Jan;42(1 Suppl):I49-61. doi: 10.1097/01.mlr.0000103520.43902.6c.
PMID: 14707755
citation: Jette DU, Stilphen M, Ranganathan VK, Passek SD, Frost FS, Jette AM. AM-PAC "6-Clicks" functional assessment scores predict acute care hospital discharge destination. Phys Ther. 2014 Sep;94(9):1252-61. doi: 10.2522/ptj.20130359. Epub 2014 Apr 24.
PMID: 24764073
citation: Menendez ME, Schumacher CS, Ring D, Freiberg AA, Rubash HE, Kwon YM. Does "6-Clicks" Day 1 Postoperative Mobility Score Predict Discharge Disposition After Total Hip and Knee Arthroplasties? J Arthroplasty. 2016 Sep;31(9):1916-20. doi: 10.1016/j.arth.2016.02.017. Epub 2016 Feb 17.
PMID: 26993155
citation: Bickler P, Brandes J, Lee M, Bozic K, Chesbro B, Claassen J. Bleeding complications from femoral and sciatic nerve catheters in patients receiving low molecular weight heparin. Anesth Analg. 2006 Oct;103(4):1036-7. doi: 10.1213/01.ane.0000237230.40246.44.
PMID: 17000826
citation: Buckenmaier CC 3rd, Shields CH, Auton AA, Evans SL, Croll SM, Bleckner LL, Brown DS, Stojadinovic A. Continuous peripheral nerve block in combat casualties receiving low-molecular weight heparin. Br J Anaesth. 2006 Dec;97(6):874-7. doi: 10.1093/bja/ael269. Epub 2006 Oct 9.
PMID: 17032662
citation: Idestrup C, Sawhney M, Nix C, Kiss A. The incidence of hematoma formation in patients with continuous femoral catheters following total knee arthroplasty while receiving rivaroxaban as thromboprophylaxis: an observational study. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):414-7. doi: 10.1097/AAP.0000000000000127.
PMID: 25102065
citation: Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates of risk. Anesth Analg. 2007 Apr;104(4):965-74. doi: 10.1213/01.ane.0000258740.17193.ec.
PMID: 17377115
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Singh Nair
investigator title: Investigator
mesh term: Bupivacaine
sharing ipd: No
ipd description: All study data will be collected and entered into the computer database. Each subject will be assigned to a random number code and the key linking the code and the subject identifier will be stored in a locked cabinet. The computer database will be password protected and will be kept on the Montefiore drive. The research manager is responsible for auditing the consistency of the data transcribed from the paper case report form to the computer. A protocol violation log will be maintained and all protocol violations will be reported to the Institutional Review Board and Data Safety Monitoring Board. The planned interim analysis (half way through the recruitment) will be mainly focused on the adverse events, rather than the efficacy of the procedure.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 