<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/NCT03270514</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17060305</org_study_id>
    <nct_id>NCT03270514</nct_id>
  </id_info>
  <brief_title>Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride</brief_title>
  <official_title>Postoperative Analgesia After Cardiac Surgery - A Double-Blind, Prospective and Randomized Comparison of Wound Infiltration With Liposomal Bupivacaine and Bupivacaine Hydrochloride</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kathirvel Subramaniam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pacira Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</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>
      The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration&#xD;
      with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and&#xD;
      cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are no studies to date on the use of LB infiltration and its analgesic efficacy in&#xD;
      cardiac surgery done through sternotomy, even though the majority of cardiac surgeries&#xD;
      utilize this approach. Moderate to severe pain is common in patients undergoing these&#xD;
      surgeries and is usually inadequately treated. Other various pain treatment modalities such&#xD;
      as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in&#xD;
      this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited&#xD;
      due to short duration of action and increased incidence of wound infection. On the other&#xD;
      hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential&#xD;
      for more adequate analgesia compared to bupivacaine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Actual">February 25, 2020</completion_date>
  <primary_completion_date type="Actual">December 13, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative Pain Intensity</measure>
    <time_frame>NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively</time_frame>
    <description>Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Narcotic Consumption</measure>
    <time_frame>0-72 hours post-operative period</time_frame>
    <description>All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Extubation</measure>
    <time_frame>From the end of surgery until the patient is extubated up to 72 hours post-operatively</time_frame>
    <description>The time it takes until the patient is extubated post-operatively will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Time to Mobilization</measure>
    <time_frame>From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*</time_frame>
    <description>The time it takes until patient ambulates will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Time to Out of Bed to Chair</measure>
    <time_frame>From time of end of surgery to time of mobilization up to 72 hours post-operatively</time_frame>
    <description>The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Time to Oral Intake</measure>
    <time_frame>From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge</time_frame>
    <description>The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-invasive Ventilation (NIV) Requirement</measure>
    <time_frame>From time of end of surgery to 72 hours post-operatively or until hospital discharge</time_frame>
    <description>Episodes of NIV such as upper airway masks or similar devices will be quantified</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-intubation</measure>
    <time_frame>From time of end of surgery to patient discharge up to one week</time_frame>
    <description>Instances of re-intubation will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Incentive Spirometry</measure>
    <time_frame>From time of end of surgery to 72 hours post-operatively</time_frame>
    <description>Frequency of incentive spirometry will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative Nausea and Vomiting</measure>
    <time_frame>From time of end of surgery to 72 hours post-operatively</time_frame>
    <description>Whether a patient experiences at least one episode of nausea and emesis will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Organ Dysfunction</measure>
    <time_frame>From date of surgery assessed up to 30 day post-operatively</time_frame>
    <description>Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital and ICU Stay</measure>
    <time_frame>From date of surgery assessed up to 30 day post-operatively</time_frame>
    <description>Length of both hospital and ICU stay will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Readmission</measure>
    <time_frame>From end of surgery assessed up to 30 days post-operatively</time_frame>
    <description>Readmission to hospital will be noted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>From end of surgery assessed up to 30 days post-operatively</time_frame>
    <description>Mortality will be noted at specific timepoints</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Delirium</measure>
    <time_frame>Assessment will be administered at 48 hours post-operatively</time_frame>
    <description>Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Delirium</measure>
    <time_frame>Assessment will be administered at 72 hours post-operatively</time_frame>
    <description>Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Given at the time of discharge up to 30 days post-operatively</time_frame>
    <description>Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronic Pain Assessment</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Subjects will be asked the two following questions: &quot;Are you currently experiencing pain?&quot; as well as &quot;Are you experiencing moderate to severe pain?&quot; with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.</description>
  </other_outcome>
  <other_outcome>
    <measure>Chronic Pain Assessment</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Subjects will be asked the two following questions: &quot;Are you currently experiencing pain?&quot; as well as &quot;Are you experiencing moderate to severe pain?&quot; with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum Cortisol Levels</measure>
    <time_frame>Measured 8, 48, and 72 hours post-operatively</time_frame>
    <description>Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Coronary Artery Stenoses</condition>
  <condition>Valve Regurgitation, Mitral</condition>
  <condition>Valve Regurgitation, Tricuspid</condition>
  <arm_group>
    <arm_group_label>Exparel Injectable Product</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine Hydrochloride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel Injectable Product</intervention_name>
    <description>Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
    <arm_group_label>Exparel Injectable Product</arm_group_label>
    <other_name>Liposomal Bupivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine Hydrochloride</intervention_name>
    <description>Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
    <arm_group_label>Bupivacaine Hydrochloride</arm_group_label>
    <other_name>Bupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft,&#xD;
             valvular heart procedures, as well as other open cardiac procedures along with&#xD;
             coronary artery bypass)&#xD;
&#xD;
          -  Surgery with the use of cardiopulmonary bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minimally invasive heart surgery through thoracotomy approach&#xD;
&#xD;
          -  Patient undergoing procedures under deep hypothermic circulatory arrest&#xD;
&#xD;
          -  Patients with active infections such as infective endocarditis&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Patients undergoing transplantations and ventricular assist device insertion&#xD;
&#xD;
          -  Patients on any mechanical circulatory support preoperatively&#xD;
&#xD;
          -  Patient's refusal&#xD;
&#xD;
          -  End stage liver or renal disease&#xD;
&#xD;
          -  Allergy to bupivacaine&#xD;
&#xD;
          -  Patient who cannot understand the study procedure or refuse to participate&#xD;
&#xD;
          -  Redo-sternotomy&#xD;
&#xD;
          -  Participation in another study&#xD;
&#xD;
          -  Patients with severe right or left ventricular dysfunction (EF&lt; 25%)&#xD;
&#xD;
          -  Patients requiring chronic opioids for chronic pain condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathirvel Subramaniam, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor and staff Anesthesiologist</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Presbyterian Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.</citation>
    <PMID>25500688</PMID>
  </reference>
  <reference>
    <citation>Sun XL, Zhao ZH, Ma JX, Li FB, Li YJ, Meng XM, Ma XL. Continuous Local Infiltration Analgesia for Pain Control After Total Knee Arthroplasty: A Meta-analysis of Randomized Controlled Trials. Medicine (Baltimore). 2015 Nov;94(45):e2005. doi: 10.1097/MD.0000000000002005.</citation>
    <PMID>26559294</PMID>
  </reference>
  <reference>
    <citation>Tong YC, Kaye AD, Urman RD. Liposomal bupivacaine and clinical outcomes. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):15-27. doi: 10.1016/j.bpa.2014.02.001. Epub 2014 Mar 15.</citation>
    <PMID>24815964</PMID>
  </reference>
  <reference>
    <citation>Kalogera E, Bakkum-Gamez JN, Weaver AL, Moriarty JP, Borah BJ, Langstraat CL, Jankowski CJ, Lovely JK, Cliby WA, Dowdy SC. Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies. Obstet Gynecol. 2016 Nov;128(5):1009-1017. doi: 10.1097/AOG.0000000000001719.</citation>
    <PMID>27741199</PMID>
  </reference>
  <reference>
    <citation>Hutchins JL, Kesha R, Blanco F, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. Anaesthesia. 2016 Aug;71(8):930-7. doi: 10.1111/anae.13502. Epub 2016 May 30.</citation>
    <PMID>27238859</PMID>
  </reference>
  <reference>
    <citation>Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.</citation>
    <PMID>26056753</PMID>
  </reference>
  <reference>
    <citation>Beck DE, Margolin DA, Babin SF, Russo CT. Benefits of a Multimodal Regimen for Postsurgical Pain Management in Colorectal Surgery. Ochsner J. 2015 Winter;15(4):408-12.</citation>
    <PMID>26730224</PMID>
  </reference>
  <reference>
    <citation>Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.</citation>
    <PMID>27505115</PMID>
  </reference>
  <reference>
    <citation>Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016. Erratum In: PLoS One. 2016;11(9):e0163687.</citation>
    <PMID>27082959</PMID>
  </reference>
  <reference>
    <citation>Knight RB, Walker PW, Keegan KA, Overholser SM, Baumgartner TS, Ebertowski JS 2nd, Aden JK, White MA. A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine. J Endourol. 2015 Sep;29(9):1019-24. doi: 10.1089/end.2014.0769. Epub 2015 Jun 5.</citation>
    <PMID>25897552</PMID>
  </reference>
  <reference>
    <citation>Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15.</citation>
    <PMID>27856266</PMID>
  </reference>
  <reference>
    <citation>Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14.</citation>
    <PMID>27422692</PMID>
  </reference>
  <reference>
    <citation>Kuang MJ, Du Y, Ma JX, He W, Fu L, Ma XL. The Efficacy of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Apr;32(4):1395-1402. doi: 10.1016/j.arth.2016.12.025. Epub 2016 Dec 23.</citation>
    <PMID>28082044</PMID>
  </reference>
  <reference>
    <citation>Ma J, Zhang W, Yao S. Liposomal bupivacaine infiltration versus femoral nerve block for pain control in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2016 Dec;36(Pt A):44-55. doi: 10.1016/j.ijsu.2016.10.007. Epub 2016 Oct 11.</citation>
    <PMID>27742564</PMID>
  </reference>
  <reference>
    <citation>Yu SW, Szulc AL, Walton SL, Davidovitch RI, Bosco JA, Iorio R. Liposomal Bupivacaine as an Adjunct to Postoperative Pain Control in Total Hip Arthroplasty. J Arthroplasty. 2016 Jul;31(7):1510-5. doi: 10.1016/j.arth.2016.01.004. Epub 2016 Jan 21.</citation>
    <PMID>26872584</PMID>
  </reference>
  <reference>
    <citation>Cherian JJ, Barrington J, Elmallah RK, Chughtai M, Mistry JB, Mont MA. Liposomal Bupivacaine Suspension, Can Reduce Length of Stay and Improve Discharge Status of Patients Undergoing Total Hip Arthroplasty. Surg Technol Int. 2015 Nov;27:235-9.</citation>
    <PMID>26680403</PMID>
  </reference>
  <reference>
    <citation>Barrington JW, Olugbode O, Lovald S, Ong K, Watson H, Emerson RH Jr. Liposomal Bupivacaine: A Comparative Study of More Than 1000 Total Joint Arthroplasty Cases. Orthop Clin North Am. 2015 Oct;46(4):469-77. doi: 10.1016/j.ocl.2015.06.003. Epub 2015 Aug 6.</citation>
    <PMID>26410636</PMID>
  </reference>
  <reference>
    <citation>Barrington JW, Halaszynski TM, Sinatra RS, Expert Working Group On Anesthesia And Orthopaedics Critical Issues In Hip And Knee Replacement Arthroplasty FT. Perioperative pain management in hip and knee replacement surgery. Am J Orthop (Belle Mead NJ). 2014 Apr;43(4 Suppl):S1-S16.</citation>
    <PMID>24911869</PMID>
  </reference>
  <reference>
    <citation>Kim J, Burke SM, Kryzanski JT, Roberts RJ, Roguski M, Qu E, Hwang SW, Liu PP, Desilier A, Riesenburger RI. The Role of Liposomal Bupivacaine in Reduction of Postoperative Pain After Transforaminal Lumbar Interbody Fusion: A Clinical Study. World Neurosurg. 2016 Jul;91:460-7. doi: 10.1016/j.wneu.2016.04.058. Epub 2016 Apr 22.</citation>
    <PMID>27113396</PMID>
  </reference>
  <reference>
    <citation>Grieff AN, Ghobrial GM, Jallo J. Use of liposomal bupivacaine in the postoperative management of posterior spinal decompression. J Neurosurg Spine. 2016 Jul;25(1):88-93. doi: 10.3171/2015.11.SPINE15957. Epub 2016 Mar 4.</citation>
    <PMID>26943250</PMID>
  </reference>
  <reference>
    <citation>Abdelsattar JM, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K, Jacobson SR, Lemaine V, Saint-Cyr M. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26.</citation>
    <PMID>26307232</PMID>
  </reference>
  <reference>
    <citation>Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012 Jan;32(1):69-76. doi: 10.1177/1090820X11430831. Epub 2011 Dec 16.</citation>
    <PMID>22179931</PMID>
  </reference>
  <reference>
    <citation>Oppenheimer AJ, Fiala TGS, Oppenheimer DC. Direct Transversus Abdominis Plane Blocks With Exparel During Abdominoplasty. Ann Plast Surg. 2016 Nov;77(5):499-500. doi: 10.1097/SAP.0000000000000659.</citation>
    <PMID>26545224</PMID>
  </reference>
  <reference>
    <citation>Morales R Jr, Mentz H 3rd, Newall G, Patronella C, Masters O 3rd. Use of abdominal field block injections with liposomal bupivicaine to control postoperative pain after abdominoplasty. Aesthet Surg J. 2013 Nov 1;33(8):1148-53. doi: 10.1177/1090820X13510720. Epub 2013 Nov 8.</citation>
    <PMID>24214950</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>Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.</citation>
    <PMID>27673545</PMID>
  </reference>
  <reference>
    <citation>Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24.</citation>
    <PMID>26507422</PMID>
  </reference>
  <reference>
    <citation>Balkhy HH, Arnsdorf S, Krienbring D, Urban J. Liposome Bupivacaine for Postsurgical Analgesia in Patients Undergoing Robotically Assisted Cardiac Surgery. Innovations (Phila). 2015 Nov-Dec;10(6):416-9. doi: 10.1097/IMI.0000000000000190.</citation>
    <PMID>26633002</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <results_first_submitted>May 5, 2021</results_first_submitted>
  <results_first_submitted_qc>August 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 5, 2021</results_first_posted>
  <disposition_first_submitted>December 11, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 10, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 5, 2021</disposition_first_posted>
  <last_update_submitted>August 10, 2021</last_update_submitted>
  <last_update_submitted_qc>August 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Kathirvel Subramaniam</investigator_full_name>
    <investigator_title>Principal Investigator, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>sternotomy</keyword>
  <keyword>post-operative pain</keyword>
  <keyword>sternal wound infiltration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Stenosis</mesh_term>
    <mesh_term>Tricuspid Valve Insufficiency</mesh_term>
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>December 6, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03270514/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Exparel Injectable Product</title>
          <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
        </group>
        <group group_id="P2">
          <title>Bupivacaine Hydrochloride</title>
          <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="31"/>
              </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>Exparel Injectable Product</title>
          <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
        </group>
        <group group_id="B2">
          <title>Bupivacaine Hydrochloride</title>
          <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</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="29"/>
            <count group_id="B2" value="31"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" lower_limit="60" upper_limit="72"/>
                    <measurement group_id="B2" value="65" lower_limit="60" upper_limit="72"/>
                    <measurement group_id="B3" value="65.5" lower_limit="60" upper_limit="72"/>
                  </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="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</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>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="54"/>
                  </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="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32" lower_limit="29.4" upper_limit="34"/>
                    <measurement group_id="B2" value="31.3" lower_limit="28.7" upper_limit="33.1"/>
                    <measurement group_id="B3" value="31.7" lower_limit="29.2" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes mellitus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Congestive heart failure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco use</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic lung disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Mild or no disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Peripheral vascular disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cerebrovascular disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Preoperative hospitalization</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematocrit</title>
          <units>Percentage Hematocrit</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40.7" lower_limit="36.6" upper_limit="43.4"/>
                    <measurement group_id="B2" value="41.8" lower_limit="38.6" upper_limit="44.3"/>
                    <measurement group_id="B3" value="41.5" lower_limit="37.9" upper_limit="43.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum creatinine</title>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.0" lower_limit="0.85" upper_limit="1.3"/>
                    <measurement group_id="B2" value="1.0" lower_limit="0.9" upper_limit="1.2"/>
                    <measurement group_id="B3" value="1.0" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total albumin</title>
          <units>g/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" lower_limit="3.8" upper_limit="4.4"/>
                    <measurement group_id="B2" value="4.1" lower_limit="3.8" upper_limit="4.3"/>
                    <measurement group_id="B3" value="4" lower_limit="3.8" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total bilirubin</title>
          <units>mg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.6" lower_limit="0.4" upper_limit="0.8"/>
                    <measurement group_id="B2" value="0.6" lower_limit="0.4" upper_limit="0.8"/>
                    <measurement group_id="B3" value="0.6" lower_limit="0.4" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Last hemoglobin A1C</title>
          <units>percentage A1C</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.2" lower_limit="5.6" upper_limit="7.2"/>
                    <measurement group_id="B2" value="6.0" lower_limit="5.7" upper_limit="7.5"/>
                    <measurement group_id="B3" value="6.1" lower_limit="5.7" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Society of thoracic surgeons predicted mortality risk</title>
          <description>The Society of Thoracic Surgeons' risk models predict the risk of operative mortality. The risk is reported as percentage values ranging from 0-100%, where higher percentages reflect greater risk of mortality</description>
          <units>percentage of mortality risk</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.009" lower_limit="0.005" upper_limit="0.013"/>
                    <measurement group_id="B2" value="0.007" lower_limit="0.005" upper_limit="0.013"/>
                    <measurement group_id="B3" value="0.008" lower_limit="0.005" upper_limit="0.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left ventricular ejection fraction</title>
          <units>percent ejection fraction</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.5" lower_limit="46.5" upper_limit="58"/>
                    <measurement group_id="B2" value="58" lower_limit="45" upper_limit="62"/>
                    <measurement group_id="B3" value="58" lower_limit="47.3" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Angiotensin converting enzyme inhibitor/angiotensin receptor blocker use</title>
          <description>Within 48 hours preoperatively</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Betablockers within 2 weeks preoperatively</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Aspirin within 5 days preoperatively</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lipid lowering drugs within 24 hours preoperatively</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Procedure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Coronary artery bypass graft</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Valve procedure</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Combined coronary artery bypass graft &amp; valve procedure</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of cardiopulmonary bypass</title>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="128" lower_limit="99.5" upper_limit="157"/>
                    <measurement group_id="B2" value="134" lower_limit="114" upper_limit="177"/>
                    <measurement group_id="B3" value="129" lower_limit="112" upper_limit="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lowest body temperature on bypass</title>
          <units>degrees Celcius</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.2" lower_limit="33" upper_limit="35.1"/>
                    <measurement group_id="B2" value="33.8" lower_limit="32.6" upper_limit="34.8"/>
                    <measurement group_id="B3" value="34" lower_limit="33" upper_limit="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of surgery</title>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="305" lower_limit="279" upper_limit="385"/>
                    <measurement group_id="B2" value="335" lower_limit="267" upper_limit="411"/>
                    <measurement group_id="B3" value="329" lower_limit="271" upper_limit="401"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-operative Pain Intensity</title>
        <description>Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement</description>
        <time_frame>NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Pain Intensity</title>
          <description>Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7482" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="5.03" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.75" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.64" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7262" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.996" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.74" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.6" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7042" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.962" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.73" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.56" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6822" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.928" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.72" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.52" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6602" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.894" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.71" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.48" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6382" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.86" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.44" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>32hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5942" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.792" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>32hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.68" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.32" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5282" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.724" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.66" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.24" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4622" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.656" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.64" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.16" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3742" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.554" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.61" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="6.04" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72hrs. at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2862" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="4.452" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72hrs. with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.58" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="5.92" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Narcotic Consumption</title>
        <description>All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.</description>
        <time_frame>0-72 hours post-operative period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Total Narcotic Consumption</title>
          <description>All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.</description>
          <units>oral morphine equivalents in mg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0-8 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="7.5" upper_limit="30"/>
                    <measurement group_id="O2" value="10" lower_limit="0" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-24 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" lower_limit="30" upper_limit="60"/>
                    <measurement group_id="O2" value="34.5" lower_limit="15" upper_limit="52.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24-48 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45" lower_limit="10" upper_limit="75"/>
                    <measurement group_id="O2" value="45" lower_limit="12" upper_limit="67.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48-72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="2.5" upper_limit="53"/>
                    <measurement group_id="O2" value="26.5" lower_limit="5" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>0-72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139" lower_limit="73" upper_limit="212"/>
                    <measurement group_id="O2" value="105" lower_limit="54.5" upper_limit="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Extubation</title>
        <description>The time it takes until the patient is extubated post-operatively will be measured</description>
        <time_frame>From the end of surgery until the patient is extubated up to 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Extubation</title>
          <description>The time it takes until the patient is extubated post-operatively will be measured</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85" lower_limit="2.65" upper_limit="8.17"/>
                    <measurement group_id="O2" value="3.47" lower_limit="2.49" upper_limit="9.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Time to Mobilization</title>
        <description>The time it takes until patient ambulates will be measured</description>
        <time_frame>From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Time to Mobilization</title>
          <description>The time it takes until patient ambulates will be measured</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" lower_limit="19" upper_limit="51"/>
                    <measurement group_id="O2" value="45" lower_limit="33" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Time to Out of Bed to Chair</title>
        <description>The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured</description>
        <time_frame>From time of end of surgery to time of mobilization up to 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Time to Out of Bed to Chair</title>
          <description>The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="11" upper_limit="19"/>
                    <measurement group_id="O2" value="16" lower_limit="8" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Time to Oral Intake</title>
        <description>The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured</description>
        <time_frame>From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Time to Oral Intake</title>
          <description>The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5" upper_limit="18"/>
                    <measurement group_id="O2" value="5.6" lower_limit="4.0" upper_limit="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-invasive Ventilation (NIV) Requirement</title>
        <description>Episodes of NIV such as upper airway masks or similar devices will be quantified</description>
        <time_frame>From time of end of surgery to 72 hours post-operatively or until hospital discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Non-invasive Ventilation (NIV) Requirement</title>
          <description>Episodes of NIV such as upper airway masks or similar devices will be quantified</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Re-intubation</title>
        <description>Instances of re-intubation will be recorded</description>
        <time_frame>From time of end of surgery to patient discharge up to one week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Re-intubation</title>
          <description>Instances of re-intubation will be recorded</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Incentive Spirometry</title>
        <description>Frequency of incentive spirometry will be measured</description>
        <time_frame>From time of end of surgery to 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Incentive Spirometry</title>
          <description>Frequency of incentive spirometry will be measured</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative Nausea and Vomiting</title>
        <description>Whether a patient experiences at least one episode of nausea and emesis will be measured</description>
        <time_frame>From time of end of surgery to 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative Nausea and Vomiting</title>
          <description>Whether a patient experiences at least one episode of nausea and emesis will be measured</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Organ Dysfunction</title>
        <description>Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted</description>
        <time_frame>From date of surgery assessed up to 30 day post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Major Organ Dysfunction</title>
          <description>Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Pneumonia</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Renal failure / hemodialysis</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cardiac arrest</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Atrial fibrillation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No major organ dysfunction</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital and ICU Stay</title>
        <description>Length of both hospital and ICU stay will be measured</description>
        <time_frame>From date of surgery assessed up to 30 day post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital and ICU Stay</title>
          <description>Length of both hospital and ICU stay will be measured</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Length of ICU stay</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.51" lower_limit="1.08" upper_limit="2.11"/>
                    <measurement group_id="O2" value="1.71" lower_limit="1.11" upper_limit="2.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Length of postoperative hospital stay</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="5.5" upper_limit="8"/>
                    <measurement group_id="O2" value="6" lower_limit="5" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Readmission</title>
        <description>Readmission to hospital will be noted</description>
        <time_frame>From end of surgery assessed up to 30 days post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Readmission</title>
          <description>Readmission to hospital will be noted</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mortality</title>
        <description>Mortality will be noted at specific timepoints</description>
        <time_frame>From end of surgery assessed up to 30 days post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Mortality</title>
          <description>Mortality will be noted at specific timepoints</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Delirium</title>
        <description>Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)</description>
        <time_frame>Assessment will be administered at 48 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Delirium</title>
          <description>Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No delirium at 48 hours postoperatively</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Delirium at 48 hours postoperatively</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No delirium assessment conducted at 48 hours postoperatively</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Delirium</title>
        <description>Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)</description>
        <time_frame>Assessment will be administered at 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Delirium</title>
          <description>Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No delirium at 72 hours postoperatively</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Subsyndromal delirium at 72 hours postoperatively</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Delirium at 72 hours postoperatively</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No delirium assessment conducted at 72 hours postoperatively</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Satisfaction</title>
        <description>Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management</description>
        <time_frame>Given at the time of discharge up to 30 days post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="8" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="9" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Chronic Pain Assessment</title>
        <description>Subjects will be asked the two following questions: &quot;Are you currently experiencing pain?&quot; as well as &quot;Are you experiencing moderate to severe pain?&quot; with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.</description>
        <time_frame>6 months after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Chronic Pain Assessment</title>
          <description>Subjects will be asked the two following questions: &quot;Are you currently experiencing pain?&quot; as well as &quot;Are you experiencing moderate to severe pain?&quot; with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Any pain at 6 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate to severe pain at 6 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No pain at 6 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Chronic Pain Assessment</title>
        <description>Subjects will be asked the two following questions: &quot;Are you currently experiencing pain?&quot; as well as &quot;Are you experiencing moderate to severe pain?&quot; with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.</description>
        <time_frame>12 months after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Chronic Pain Assessment</title>
          <description>Subjects will be asked the two following questions: &quot;Are you currently experiencing pain?&quot; as well as &quot;Are you experiencing moderate to severe pain?&quot; with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Any pain at 12 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate to severe pain at 12 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No pain at 12 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Serum Cortisol Levels</title>
        <description>Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.</description>
        <time_frame>Measured 8, 48, and 72 hours post-operatively</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel Injectable Product</title>
            <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine Hydrochloride</title>
            <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Cortisol Levels</title>
          <description>Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.</description>
          <units>µg/dL</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>8 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="23" upper_limit="40"/>
                    <measurement group_id="O2" value="36.5" lower_limit="27" upper_limit="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="11" upper_limit="20"/>
                    <measurement group_id="O2" value="19" lower_limit="14" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>72 hours postoperatively</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16" lower_limit="11" upper_limit="18"/>
                    <measurement group_id="O2" value="17" lower_limit="13" upper_limit="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>from the time of consent, adverse events were monitored for 30 days or hospital discharge, whichever came first</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Exparel Injectable Product</title>
          <description>Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).&#xD;
Exparel Injectable Product: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
        </group>
        <group group_id="E2">
          <title>Bupivacaine Hydrochloride</title>
          <description>Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).&#xD;
Bupivacaine Hydrochloride: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Hypotension requiring aortic balloon pump</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Pulmonary Arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vasodilatory Shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Ectopy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Pulmonary Insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Kathirvel Subramaniam, MD, MPH, FASE</name_or_title>
      <organization>University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine</organization>
      <phone>724-799-5852</phone>
      <email>subramaniamk@upmc.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/NCT03270514
org study id: PRO17060305
nct id: NCT03270514
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration
      with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and
      cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
There are no studies to date on the use of LB infiltration and its analgesic efficacy in
      cardiac surgery done through sternotomy, even though the majority of cardiac surgeries
      utilize this approach. Moderate to severe pain is common in patients undergoing these
      surgeries and is usually inadequately treated. Other various pain treatment modalities such
      as opioid and neuraxial anesthesia are avoided due to potentially dangerous side effects in
      this cohort. The efficacy of local anesthesia techniques, such as bupivacaine, are limited
      due to short duration of action and increased incidence of wound infection. On the other
      hand, slow release liposomal bupivacaine may last up to 72 hours, indicating it's potential
      for more adequate analgesia compared to bupivacaine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion
measure: Post-operative Pain Intensity
time frame: NRS scores will be evaluated every 4 hours until 24 hours post-operatively, every 8 hours until 48 hours post-operatively, and every 12 hours for 72 hours post-operatively
description: Postoperative pain scores evaluated by numeric rating scale or (NRS) where 0- no pain and 10- worst pain, at rest and at movement
measure: Total Narcotic Consumption
time frame: 0-72 hours post-operative period
description: All narcotics administered in the first 0-8, 8-24, 24-48, and 48-72 hours and the total narcotics administered in the 0-72 hours postoperative period(PCA narcotics, nurse-administered IV narcotics, and oral narcotics). All narcotics will be converted to total IV morphine equivalent for comparison between two groups.
measure: Time to Extubation
time frame: From the end of surgery until the patient is extubated up to 72 hours post-operatively
description: The time it takes until the patient is extubated post-operatively will be measured
measure: Patient Time to Mobilization
time frame: From time of end of surgery to time of mobilization up to 72 hours or discharge, *assessed up to 120 hours*
description: The time it takes until patient ambulates will be measured
measure: Patient Time to Out of Bed to Chair
time frame: From time of end of surgery to time of mobilization up to 72 hours post-operatively
description: The time it takes until the patient advances from bedrest to out of bed (OOB) to chair will be measured
measure: Patient Time to Oral Intake
time frame: From time of end of surgery to time of oral intake up to 72 hours post-operatively or until hospital discharge
description: The time it takes until the patient is able to/medically cleared to consume food or liquid will be measured
measure: Non-invasive Ventilation (NIV) Requirement
time frame: From time of end of surgery to 72 hours post-operatively or until hospital discharge
description: Episodes of NIV such as upper airway masks or similar devices will be quantified
measure: Re-intubation
time frame: From time of end of surgery to patient discharge up to one week
description: Instances of re-intubation will be recorded
measure: Use of Incentive Spirometry
time frame: From time of end of surgery to 72 hours post-operatively
description: Frequency of incentive spirometry will be measured
measure: Post-operative Nausea and Vomiting
time frame: From time of end of surgery to 72 hours post-operatively
description: Whether a patient experiences at least one episode of nausea and emesis will be measured
measure: Major Organ Dysfunction
time frame: From date of surgery assessed up to 30 day post-operatively
description: Organ systems such as cardiac, renal, respiratory, and nervous system failure/dysfunction in accordance with the Society of Thoracic Surgeon's database will be noted
measure: Length of Hospital and ICU Stay
time frame: From date of surgery assessed up to 30 day post-operatively
description: Length of both hospital and ICU stay will be measured
measure: Hospital Readmission
time frame: From end of surgery assessed up to 30 days post-operatively
description: Readmission to hospital will be noted
measure: Mortality
time frame: From end of surgery assessed up to 30 days post-operatively
description: Mortality will be noted at specific timepoints
measure: Delirium
time frame: Assessment will be administered at 48 hours post-operatively
description: Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
measure: Delirium
time frame: Assessment will be administered at 72 hours post-operatively
description: Patients will be assessed for delirium using the Intensive Care Delirium Screening Checklist (ICDSC)
measure: Patient Satisfaction
time frame: Given at the time of discharge up to 30 days post-operatively
description: Patient will give an assessment regarding pain management on a scale of 0 - 10 with 0 indicating the lowest satisfaction with pain management and 10 indicating the highest satisfaction with pain management
measure: Chronic Pain Assessment
time frame: 6 months after surgery
description: Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.
measure: Chronic Pain Assessment
time frame: 12 months after surgery
description: Subjects will be asked the two following questions: "Are you currently experiencing pain?" as well as "Are you experiencing moderate to severe pain?" with moderate to severe indicated as a pain score of 4-10 on 0 to 10 scale, with 0 being no pain at all and 10 being the worst pain imaginable.
measure: Serum Cortisol Levels
time frame: Measured 8, 48, and 72 hours post-operatively
description: Stress response suppression as a result of treatment will be evaluated by comparing hormone levels between the groups. Serum cortisol levels will be taken to measure this.
arm group label: Exparel Injectable Product
arm group type: Experimental
description: Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (~30).
arm group label: Bupivacaine Hydrochloride
arm group type: Active Comparator
description: Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (~30).
intervention type: Drug
intervention name: Exparel Injectable Product
description: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
arm group label: Exparel Injectable Product
other name: Liposomal Bupivacaine
intervention type: Drug
intervention name: Bupivacaine Hydrochloride
description: Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
arm group label: Bupivacaine Hydrochloride
other name: Bupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kathirvel Subramaniam, MD, MPH
role: Principal Investigator
affiliation: Associate Professor and staff Anesthesiologist
facility: 
country: United States
citation: Bigeleisen PE, Goehner N. Novel approaches in pain management in cardiac surgery. Curr Opin Anaesthesiol. 2015 Feb;28(1):89-94. doi: 10.1097/ACO.0000000000000147.
PMID: 25500688
citation: Sun XL, Zhao ZH, Ma JX, Li FB, Li YJ, Meng XM, Ma XL. Continuous Local Infiltration Analgesia for Pain Control After Total Knee Arthroplasty: A Meta-analysis of Randomized Controlled Trials. Medicine (Baltimore). 2015 Nov;94(45):e2005. doi: 10.1097/MD.0000000000002005.
PMID: 26559294
citation: Tong YC, Kaye AD, Urman RD. Liposomal bupivacaine and clinical outcomes. Best Pract Res Clin Anaesthesiol. 2014 Mar;28(1):15-27. doi: 10.1016/j.bpa.2014.02.001. Epub 2014 Mar 15.
PMID: 24815964
citation: Kalogera E, Bakkum-Gamez JN, Weaver AL, Moriarty JP, Borah BJ, Langstraat CL, Jankowski CJ, Lovely JK, Cliby WA, Dowdy SC. Abdominal Incision Injection of Liposomal Bupivacaine and Opioid Use After Laparotomy for Gynecologic Malignancies. Obstet Gynecol. 2016 Nov;128(5):1009-1017. doi: 10.1097/AOG.0000000000001719.
PMID: 27741199
citation: Hutchins JL, Kesha R, Blanco F, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. Anaesthesia. 2016 Aug;71(8):930-7. doi: 10.1111/anae.13502. Epub 2016 May 30.
PMID: 27238859
citation: Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
PMID: 26056753
citation: Beck DE, Margolin DA, Babin SF, Russo CT. Benefits of a Multimodal Regimen for Postsurgical Pain Management in Colorectal Surgery. Ochsner J. 2015 Winter;15(4):408-12.
PMID: 26730224
citation: Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.
PMID: 27505115
citation: Ayad S, Babazade R, Elsharkawy H, Nadar V, Lokhande C, Makarova N, Khanna R, Sessler DI, Turan A. Comparison of Transversus Abdominis Plane Infiltration with Liposomal Bupivacaine versus Continuous Epidural Analgesia versus Intravenous Opioid Analgesia. PLoS One. 2016 Apr 15;11(4):e0153675. doi: 10.1371/journal.pone.0153675. eCollection 2016. Erratum In: PLoS One. 2016;11(9):e0163687.
PMID: 27082959
citation: Knight RB, Walker PW, Keegan KA, Overholser SM, Baumgartner TS, Ebertowski JS 2nd, Aden JK, White MA. A Randomized Controlled Trial for Pain Control in Laparoscopic Urologic Surgery: 0.25% Bupivacaine Versus Long-Acting Liposomal Bupivacaine. J Endourol. 2015 Sep;29(9):1019-24. doi: 10.1089/end.2014.0769. Epub 2015 Jun 5.
PMID: 25897552
citation: Routman HD, Israel LR, Moor MA, Boltuch AD. Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty. J Shoulder Elbow Surg. 2017 Apr;26(4):641-647. doi: 10.1016/j.jse.2016.09.033. Epub 2016 Nov 15.
PMID: 27856266
citation: Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14.
PMID: 27422692
citation: Kuang MJ, Du Y, Ma JX, He W, Fu L, Ma XL. The Efficacy of Liposomal Bupivacaine Using Periarticular Injection in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Arthroplasty. 2017 Apr;32(4):1395-1402. doi: 10.1016/j.arth.2016.12.025. Epub 2016 Dec 23.
PMID: 28082044
citation: Ma J, Zhang W, Yao S. Liposomal bupivacaine infiltration versus femoral nerve block for pain control in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2016 Dec;36(Pt A):44-55. doi: 10.1016/j.ijsu.2016.10.007. Epub 2016 Oct 11.
PMID: 27742564
citation: Yu SW, Szulc AL, Walton SL, Davidovitch RI, Bosco JA, Iorio R. Liposomal Bupivacaine as an Adjunct to Postoperative Pain Control in Total Hip Arthroplasty. J Arthroplasty. 2016 Jul;31(7):1510-5. doi: 10.1016/j.arth.2016.01.004. Epub 2016 Jan 21.
PMID: 26872584
citation: Cherian JJ, Barrington J, Elmallah RK, Chughtai M, Mistry JB, Mont MA. Liposomal Bupivacaine Suspension, Can Reduce Length of Stay and Improve Discharge Status of Patients Undergoing Total Hip Arthroplasty. Surg Technol Int. 2015 Nov;27:235-9.
PMID: 26680403
citation: Barrington JW, Olugbode O, Lovald S, Ong K, Watson H, Emerson RH Jr. Liposomal Bupivacaine: A Comparative Study of More Than 1000 Total Joint Arthroplasty Cases. Orthop Clin North Am. 2015 Oct;46(4):469-77. doi: 10.1016/j.ocl.2015.06.003. Epub 2015 Aug 6.
PMID: 26410636
citation: Barrington JW, Halaszynski TM, Sinatra RS, Expert Working Group On Anesthesia And Orthopaedics Critical Issues In Hip And Knee Replacement Arthroplasty FT. Perioperative pain management in hip and knee replacement surgery. Am J Orthop (Belle Mead NJ). 2014 Apr;43(4 Suppl):S1-S16.
PMID: 24911869
citation: Kim J, Burke SM, Kryzanski JT, Roberts RJ, Roguski M, Qu E, Hwang SW, Liu PP, Desilier A, Riesenburger RI. The Role of Liposomal Bupivacaine in Reduction of Postoperative Pain After Transforaminal Lumbar Interbody Fusion: A Clinical Study. World Neurosurg. 2016 Jul;91:460-7. doi: 10.1016/j.wneu.2016.04.058. Epub 2016 Apr 22.
PMID: 27113396
citation: Grieff AN, Ghobrial GM, Jallo J. Use of liposomal bupivacaine in the postoperative management of posterior spinal decompression. J Neurosurg Spine. 2016 Jul;25(1):88-93. doi: 10.3171/2015.11.SPINE15957. Epub 2016 Mar 4.
PMID: 26943250
citation: Abdelsattar JM, Boughey JC, Fahy AS, Jakub JW, Farley DR, Hieken TJ, Degnim AC, Goede W, Mohan AT, Harmsen WS, Niesen AD, Tran NV, Bakri K, Jacobson SR, Lemaine V, Saint-Cyr M. Comparative Study of Liposomal Bupivacaine Versus Paravertebral Block for Pain Control Following Mastectomy with Immediate Tissue Expander Reconstruction. Ann Surg Oncol. 2016 Feb;23(2):465-70. doi: 10.1245/s10434-015-4833-4. Epub 2015 Aug 26.
PMID: 26307232
citation: Smoot JD, Bergese SD, Onel E, Williams HT, Hedden W. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammaplasty: a randomized, double-blind, active-control study. Aesthet Surg J. 2012 Jan;32(1):69-76. doi: 10.1177/1090820X11430831. Epub 2011 Dec 16.
PMID: 22179931
citation: Oppenheimer AJ, Fiala TGS, Oppenheimer DC. Direct Transversus Abdominis Plane Blocks With Exparel During Abdominoplasty. Ann Plast Surg. 2016 Nov;77(5):499-500. doi: 10.1097/SAP.0000000000000659.
PMID: 26545224
citation: Morales R Jr, Mentz H 3rd, Newall G, Patronella C, Masters O 3rd. Use of abdominal field block injections with liposomal bupivicaine to control postoperative pain after abdominoplasty. Aesthet Surg J. 2013 Nov 1;33(8):1148-53. doi: 10.1177/1090820X13510720. Epub 2013 Nov 8.
PMID: 24214950
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: Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.
PMID: 27673545
citation: Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24.
PMID: 26507422
citation: Balkhy HH, Arnsdorf S, Krienbring D, Urban J. Liposome Bupivacaine for Postsurgical Analgesia in Patients Undergoing Robotically Assisted Cardiac Surgery. Innovations (Phila). 2015 Nov-Dec;10(6):416-9. doi: 10.1097/IMI.0000000000000190.
PMID: 26633002
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Kathirvel Subramaniam
investigator title: Principal Investigator, Associate Professor
mesh term: Coronary Artery Disease
mesh term: Coronary Stenosis
mesh term: Tricuspid Valve Insufficiency
mesh term: Mitral Valve Insufficiency
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 