<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/NCT03304444</url>
  </required_header>
  <id_info>
    <org_study_id>FWA00004123</org_study_id>
    <nct_id>NCT03304444</nct_id>
  </id_info>
  <brief_title>A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery</brief_title>
  <official_title>A Pilot Study: A Comparison of Liposomal Bupivacaine to Bupivacaine HCl in Transversus Abdominis Planus Block for Abdominal Gynecologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abington Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abington Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in&#xD;
      Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the&#xD;
      hospital, total narcotic use, and overall complications rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed pilot study is evaluating the use of Exparel ™ in an anesthesia protocol for&#xD;
      patients undergoing major lower abdominal gynecologic surgery. Exparel ™ is a formulation of&#xD;
      liposomal bupivicaine that is reputed to have a much longer duration of action compares to&#xD;
      bupivacaine. Exparel™ has been originally demonstrated to be safe and effective in&#xD;
      bunionectomy and hemorrhoidectomy. It has recently gained FDA approval for all surgical site&#xD;
      infiltration including TAP (Transversus Abdominis Planus block) blocks. Exparel™ has also&#xD;
      been studied in other procedures and demonstrated reduction in opioid use and median length&#xD;
      of stay (LOS).&#xD;
&#xD;
      Currently, patients on the gynecologic oncology service undergoing major abdominal surgery&#xD;
      are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as&#xD;
      part of an effort to decrease narcotic use post-operatively and decrease hospital length of&#xD;
      stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing&#xD;
      immediate post operative pain. As Exparel™ is anticipated to have a longer duration of&#xD;
      action, the purpose of this study is to determine if TAP blocks with Exparel™ have an&#xD;
      advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay&#xD;
      in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result&#xD;
      in reduced length of stay contributing to significant hospital cost savings. Secondary&#xD;
      outcomes include total narcotic use (hypothesized to be reduced) and overall complication&#xD;
      rates (hypothesized to remain unchanged). Given there are no published data on the efficacy&#xD;
      and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of stay post operatively in hospital</measure>
    <time_frame>through study completion, expected to be approximately 1 year in total</time_frame>
    <description>number of hours patient stays post operatively in hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>total opioid use post operatively in hospital</measure>
    <time_frame>through study completion, expected to be approximately 1 year in total</time_frame>
    <description>total opioid use in morphine equivalent that patient uses</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Gynecologic Cancer</condition>
  <condition>Post Operative Pain</condition>
  <arm_group>
    <arm_group_label>Bupivacaine HCl in TAP block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>When performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials).&#xD;
When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal Bupivicaine in TAP block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>When performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>bupivacaine hydrochloride used in TAP block</description>
    <arm_group_label>Bupivacaine HCl in TAP block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liposomal bupivacaine</intervention_name>
    <description>liposomal bupivacaine used in TAP block</description>
    <arm_group_label>Liposomal Bupivicaine in TAP block</arm_group_label>
    <other_name>Exparel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing planned exploratory laparotomy&#xD;
&#xD;
          -  TAP blocks placed after the laparotomy incision is closed, but before the patient is&#xD;
             awake, and placed under ultrasound guidance with correct identification of the correct&#xD;
             abdominal plane.&#xD;
&#xD;
          -  Consent for TAP block signed by patients preoperatively by anesthesiology&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All pregnant patients&#xD;
&#xD;
          -  All patients under 18 years of age&#xD;
&#xD;
          -  minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy&#xD;
&#xD;
          -  medical contraindications to use of bupivacaine or liposomal bupivacaine such as&#xD;
             severe hepatic and/or renal disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heidi Ching, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OB GYN Resident</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heidi Ching, MD</last_name>
    <phone>215-481-4231</phone>
    <email>heidi.ching@jefferson.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Shahin, MD</last_name>
    <phone>215-885-0220</phone>
    <email>mark.shahin@jefferson.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Abington Hospital Jefferson Health</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mark Shahin, MD</last_name>
      <phone>215-885-0220</phone>
      <email>mark.shahin@jefferson.edu</email>
    </contact>
    <contact_backup>
      <last_name>Heidi Ching, MD</last_name>
      <phone>215-481-4211</phone>
      <email>heidi.ching@jefferson.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 13, 2016</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Abington Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Heidi Ching, MD</investigator_full_name>
    <investigator_title>OBGYN Resident Physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03304444/SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03304444/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03304444/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03304444
org study id: FWA00004123
nct id: NCT03304444
lead sponsor: 
has dmc: No
This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in
      Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the
      hospital, total narcotic use, and overall complications rates.
The proposed pilot study is evaluating the use of Exparel ™ in an anesthesia protocol for
      patients undergoing major lower abdominal gynecologic surgery. Exparel ™ is a formulation of
      liposomal bupivicaine that is reputed to have a much longer duration of action compares to
      bupivacaine. Exparel™ has been originally demonstrated to be safe and effective in
      bunionectomy and hemorrhoidectomy. It has recently gained FDA approval for all surgical site
      infiltration including TAP (Transversus Abdominis Planus block) blocks. Exparel™ has also
      been studied in other procedures and demonstrated reduction in opioid use and median length
      of stay (LOS).

      Currently, patients on the gynecologic oncology service undergoing major abdominal surgery
      are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as
      part of an effort to decrease narcotic use post-operatively and decrease hospital length of
      stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing
      immediate post operative pain. As Exparel™ is anticipated to have a longer duration of
      action, the purpose of this study is to determine if TAP blocks with Exparel™ have an
      advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay
      in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result
      in reduced length of stay contributing to significant hospital cost savings. Secondary
      outcomes include total narcotic use (hypothesized to be reduced) and overall complication
      rates (hypothesized to remain unchanged). Given there are no published data on the efficacy
      and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Length of stay post operatively in hospital
time frame: through study completion, expected to be approximately 1 year in total
description: number of hours patient stays post operatively in hospital
measure: total opioid use post operatively in hospital
time frame: through study completion, expected to be approximately 1 year in total
description: total opioid use in morphine equivalent that patient uses
arm group label: Bupivacaine HCl in TAP block
arm group type: Active Comparator
description: When performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials).
When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon.
arm group label: Liposomal Bupivicaine in TAP block
arm group type: Experimental
description: When performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
intervention type: Drug
intervention name: Bupivacaine
description: bupivacaine hydrochloride used in TAP block
arm group label: Bupivacaine HCl in TAP block
intervention type: Drug
intervention name: liposomal bupivacaine
description: liposomal bupivacaine used in TAP block
arm group label: Liposomal Bupivicaine in TAP block
other name: Exparel
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heidi Ching, MD
role: Principal Investigator
affiliation: OB GYN Resident
last name: Heidi Ching, MD
phone: 215-481-4231
email: heidi.ching@jefferson.edu
last name: Mark Shahin, MD
phone: 215-885-0220
email: mark.shahin@jefferson.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Abington Memorial Hospital
investigator full name: Heidi Ching, MD
investigator title: OBGYN Resident Physician
mesh term: Pain, Postoperative
mesh term: Bupivacaine
provided document: 
provided document: 
provided document: 