<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/NCT02214810</url>
  </required_header>
  <id_info>
    <org_study_id>5187</org_study_id>
    <nct_id>NCT02214810</nct_id>
  </id_info>
  <brief_title>A Study of Postsurgical Pain Control for Lower Extremity Fractures</brief_title>
  <official_title>A Randomized, Single-blinded, Prospective Study of Postsurgical Pain Control After Open Reduction and Internal Fixation of Lower Extremity Fractures With Liposomal Marcaine.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Broward Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Broward Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postsurgical pain may effectively be treated with a multimodal approach that incorporates the&#xD;
      use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be&#xD;
      effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to&#xD;
      reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease&#xD;
      hospital length of stay. However, local anesthetics, via wound infiltration, are often&#xD;
      short-acting and do not meet the duration of postsurgical pain due to their solubility and&#xD;
      protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine&#xD;
      that allows for 72 hours of postsurgical analgesia with a single injection. This formulation&#xD;
      has been shown to have little to no adverse effects; although some studies have reported&#xD;
      adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and&#xD;
      dizziness. The occurrences of these adverse events were still less than the placebo cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered&#xD;
      the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical&#xD;
      fixation would be included. Written, informed consent to enrollment will be recorded and&#xD;
      included in the patient record. The study is designed around the standard of care for&#xD;
      postsurgical pain management. There are no additional costs to the patient strictly related&#xD;
      to this study.&#xD;
&#xD;
      Patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical&#xD;
      investigators at a single institution. A sealed, opaque envelope, selected in the&#xD;
      pre-operative holding area, will accompany each patient participant to the operating room.&#xD;
      The envelope will be opened at the conclusion of the fracture fixation to reveal patient&#xD;
      assignment to either study Group 1 or Group 2. Once the total numbers of patients have&#xD;
      completed their procedures and follow-up, the study will close.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Visual Analogue Scale (VAS)</measure>
    <time_frame>72 hours</time_frame>
    <description>Patients will be asked to complete a Pain Visual Analogue Scale every 2 hours for the first 12 hours of their stay (2, 4, 6, 8, 10, 12), and then again at 24, 30 and 72 hours into their hospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Management Satisfaction</measure>
    <time_frame>2 weeks, post-operatively</time_frame>
    <description>Patients will complete the post-surgery satisfaction form at their 2-week, post-operative office visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lower Extremity Fractures.</condition>
  <arm_group>
    <arm_group_label>Control- Marcain</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 1 will receive non-liposomal bupivacaine introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental- Exparel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 will receive a mixture of non-liposomal bupivacaine and Exparel introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine/Exparel</intervention_name>
    <description>The opaque envelope, which was selected by the treating physician, will accompany each of the study participants will be opened and the patient identified as belonging to either Group 1 or Group 2. It is important to note that randomization of the envelopes were computer-generated and placed by a co-investigator; the treating physician is completely unaware of the order of the opaque envelopes. Patients in Group 1 will receive a standardized medication regimen including non-liposomal bupivacaine by soft-tissue injection at the conclusion of their surgical procedure. Those in Group 2 will receive non-liposomal bupivacaine and ExparelTM by soft-tissue injection at the conclusion of their surgical procedure. Study participants will undergo injection in this manner until the conclusion of the study.</description>
    <arm_group_label>Control- Marcain</arm_group_label>
    <arm_group_label>Experimental- Exparel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  Preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to ExparelTM or certain other local anesthetic agents&#xD;
&#xD;
          -  Surgery performed at an outside institution or by a different surgeon&#xD;
&#xD;
          -  Chronic analgesic users (defined as use of opioid medication &gt;14 days in the past 3&#xD;
             months, or use of non-opioid pain medication &gt;5 times per week&#xD;
&#xD;
          -  Pregnant females or females who think they may become pregnant&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  Major psychiatric disease&#xD;
&#xD;
          -  Inability to comprehend the nature of the study&#xD;
&#xD;
          -  Unwillingness to provide signed informed consent&#xD;
&#xD;
          -  Markedly abnormal kidney function or renal disease&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Signs or symptoms of compartment syndrome&#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>Brian J Cross, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Broward Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Broward Health Medical Center</name>
      <address>
        <city>Ft. Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>References 1-Candoitti 2012 2-Gupta Curr Opin Anaesthesiol 2010, Liu J Am Coll Surg 2006 3-Lynch Anesth Analg 1997, Amin J Surg Pakistan 2010 4-Golf Adv Ther 2011, Onel 2011, Bergese IARS Annual Meeting 2011 5-Angst Clin Pharmacokinet 2006, Howell Cancer J 2001</citation>
  </results_reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>February 18, 2016</last_update_submitted>
  <last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bupivacaine</keyword>
  <keyword>multimodal</keyword>
  <keyword>exparel</keyword>
  <keyword>open reduction</keyword>
  <keyword>internal fixation</keyword>
  <keyword>post-surgical pain control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02214810
org study id: 5187
nct id: NCT02214810
lead sponsor: 
has dmc: Yes
Postsurgical pain may effectively be treated with a multimodal approach that incorporates the
      use of local anesthetics. Bupivacaine is a local anesthetic that has been proven to be
      effective at reducing postsurgical pain. Furthermore, this local anesthetic has been shown to
      reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease
      hospital length of stay. However, local anesthetics, via wound infiltration, are often
      short-acting and do not meet the duration of postsurgical pain due to their solubility and
      protein-binding properties. ExparelTM is an FDA-approved liposomal formulation of bupivacaine
      that allows for 72 hours of postsurgical analgesia with a single injection. This formulation
      has been shown to have little to no adverse effects; although some studies have reported
      adverse effects with the use of ExaprelTM, most frequently being nausea, vomiting, and
      dizziness. The occurrences of these adverse events were still less than the placebo cohort.
All patients undergoing surgical fixation of a lower extremity fracture(s) will be offered
      the opportunity to enroll in the study. Patients undergoing unilateral or bilateral surgical
      fixation would be included. Written, informed consent to enrollment will be recorded and
      included in the patient record. The study is designed around the standard of care for
      postsurgical pain management. There are no additional costs to the patient strictly related
      to this study.

      Patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical
      investigators at a single institution. A sealed, opaque envelope, selected in the
      pre-operative holding area, will accompany each patient participant to the operating room.
      The envelope will be opened at the conclusion of the fracture fixation to reveal patient
      assignment to either study Group 1 or Group 2. Once the total numbers of patients have
      completed their procedures and follow-up, the study will close.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Pain Visual Analogue Scale (VAS)
time frame: 72 hours
description: Patients will be asked to complete a Pain Visual Analogue Scale every 2 hours for the first 12 hours of their stay (2, 4, 6, 8, 10, 12), and then again at 24, 30 and 72 hours into their hospitalization.
measure: Pain Management Satisfaction
time frame: 2 weeks, post-operatively
description: Patients will complete the post-surgery satisfaction form at their 2-week, post-operative office visit.
arm group label: Control- Marcain
arm group type: Active Comparator
description: Group 1 will receive non-liposomal bupivacaine introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
arm group label: Experimental- Exparel
arm group type: Experimental
description: Group 2 will receive a mixture of non-liposomal bupivacaine and Exparel introduced into the soft tissue surrounding the fracture at the conclusion of the surgery.
intervention type: Drug
intervention name: Bupivacaine/Exparel
description: The opaque envelope, which was selected by the treating physician, will accompany each of the study participants will be opened and the patient identified as belonging to either Group 1 or Group 2. It is important to note that randomization of the envelopes were computer-generated and placed by a co-investigator; the treating physician is completely unaware of the order of the opaque envelopes. Patients in Group 1 will receive a standardized medication regimen including non-liposomal bupivacaine by soft-tissue injection at the conclusion of their surgical procedure. Those in Group 2 will receive non-liposomal bupivacaine and ExparelTM by soft-tissue injection at the conclusion of their surgical procedure. Study participants will undergo injection in this manner until the conclusion of the study.
arm group label: Control- Marcain
arm group label: Experimental- Exparel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian J Cross, MD
role: Principal Investigator
affiliation: Broward Health
facility: 
country: United States
citation: References 1-Candoitti 2012 2-Gupta Curr Opin Anaesthesiol 2010, Liu J Am Coll Surg 2006 3-Lynch Anesth Analg 1997, Amin J Surg Pakistan 2010 4-Golf Adv Ther 2011, Onel 2011, Bergese IARS Annual Meeting 2011 5-Angst Clin Pharmacokinet 2006, Howell Cancer J 2001
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Fractures, Bone
mesh term: Bupivacaine