<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/NCT03247257</url>
  </required_header>
  <id_info>
    <org_study_id>482717 revised</org_study_id>
    <nct_id>NCT03247257</nct_id>
  </id_info>
  <brief_title>Comparing Epidural Versus General Anesthesia for LESS Cholecystectomies</brief_title>
  <official_title>Epidural Versus General Anesthesia for Laparoendoscopic Single Site Cholecystectomy: A Prospective, Comparative, Controlled, Blinded Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida Hospital Tampa Bay Division</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida Hospital Tampa Bay Division</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective, comparative, controlled, blinded study that will enroll a total&#xD;
      of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder&#xD;
      removal. The objective of this study is to compare Epidural versus General Anesthesia for&#xD;
      postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, comparative, controlled, blinded study that will enroll a total of 70&#xD;
      adult patients that require an elective cholecystectomy.&#xD;
&#xD;
      Patients will be randomized 1:1 to receive either general anesthesia (Group A) or epidural&#xD;
      anesthesia (Group B) for their laparoendoscopic single site incision (LESS) gallbladder&#xD;
      removal surgery (cholecystectomy). Randomization will be achieved using a computer-generated&#xD;
      list. The patient will know what are they are randomized to before entering the operating&#xD;
      room because an epidural will need to be placed preoperatively. Standards for basic&#xD;
      anesthetic monitoring approved by the American Society of Anesthesiologists will occur&#xD;
      intraoperatively.&#xD;
&#xD;
      Postoperative evaluations will be completed by a medical professional that is blinded to the&#xD;
      type of anesthesia used during the LESS surgery. Postoperative evaluations include a physical&#xD;
      exam, adverse events, medication administration, vital signs and post-anesthesia recovery&#xD;
      score for ambulatory patients (PARSAP) scores will be taken every 15 minutes until the&#xD;
      patient has a score of at least 18.&#xD;
&#xD;
      Patients will be followed 90 days postoperatively to collect pain scores, analgesic use,&#xD;
      adverse events, and quality of life questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post Anesthesia Recovery Score for Ambulatory Patients</measure>
    <time_frame>Immediately postoperative</time_frame>
    <description>PARSAP scores in the post-anesthesia recovery unit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-12 Health survey scores</measure>
    <time_frame>Postoperative days 1, 6, 7/8/9 or 10, 30, 90</time_frame>
    <description>scale of 12-47</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Immediately postoperative through postoperative day 90</time_frame>
    <description>VAS 0-10 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid requirement</measure>
    <time_frame>Preoperative through postoperative day 90</time_frame>
    <description>Opioid use in milligrams through postoperative day 90 will be recorded.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Cholelithiasis</condition>
  <arm_group>
    <arm_group_label>Group A: General Anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Epidural Anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>General Anesthesia</intervention_name>
    <description>Patients will be put under general anesthesia for cholecystectomy</description>
    <arm_group_label>Group A: General Anesthesia</arm_group_label>
    <other_name>IV propofol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Epidural Anesthesia</intervention_name>
    <description>Patients will receive Epidural Anesthesia for cholecystectomy</description>
    <arm_group_label>Group B: Epidural Anesthesia</arm_group_label>
    <other_name>Epidural lidocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged between 18 and 65 years of age&#xD;
&#xD;
          -  ASA I or II&#xD;
&#xD;
          -  Patient has a diagnosis of biliary colic with documented cholecystitis, symptomatic&#xD;
             gallstones, polyps by imaging or biliary dyskinesia with documented EF &lt; 30%&#xD;
&#xD;
          -  No cardiopulmonary disease&#xD;
&#xD;
          -  Normal coagulation profile&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any female patient, who is pregnant, suspected pregnant, or nursing&#xD;
&#xD;
          -  Contraindication for pneumoperitoneum&#xD;
&#xD;
          -  Contraindication for epidural anesthesia&#xD;
&#xD;
          -  Allergy to local anesthetic agents&#xD;
&#xD;
          -  Any patient with acute calculus or acalculous cholecystitis&#xD;
&#xD;
          -  Any patient who has had an upper midline or right sub costal incision&#xD;
&#xD;
          -  Any patient with preoperative indication for a cholangiogram&#xD;
&#xD;
          -  Any patient with ASA ≥ 3&#xD;
&#xD;
          -  Any patient who is undergoing Peritoneal Dialysis (PD)&#xD;
&#xD;
          -  History of long term analgesic use requiring pain management (&gt;1 week)&#xD;
&#xD;
          -  Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia&#xD;
             repair&#xD;
&#xD;
          -  Any patient with obstructive sleep apnea (OSA), history of OSA or at high risk of OSA&#xD;
             as determined by the STOP Questionnaire&#xD;
&#xD;
          -  BMI &gt; 35 kg/m2&#xD;
&#xD;
          -  Any patient with a history of severe, uncontrolled GERD&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharona Ross, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida Hospital Tampa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexander Rosemurgy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida Hospital Tampa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida Hospital Tampa</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida Hospital Tampa Bay Division</investigator_affiliation>
    <investigator_full_name>Alexander Rosemurgy</investigator_full_name>
    <investigator_title>Director Surgical Digestive Disorders and GERD Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholelithiasis</mesh_term>
    <mesh_term>Cholecystolithiasis</mesh_term>
    <mesh_term>Gallstones</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Propofol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03247257
org study id: 482717 revised
nct id: NCT03247257
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a prospective, comparative, controlled, blinded study that will enroll a total
      of 70 adults that will undergo elective laparoendoscopic single-site incision gallbladder
      removal. The objective of this study is to compare Epidural versus General Anesthesia for
      postoperative pain, length of hospital stay, outcomes, and cost of post-cholecystectomy
      patients.
This is a prospective, comparative, controlled, blinded study that will enroll a total of 70
      adult patients that require an elective cholecystectomy.

      Patients will be randomized 1:1 to receive either general anesthesia (Group A) or epidural
      anesthesia (Group B) for their laparoendoscopic single site incision (LESS) gallbladder
      removal surgery (cholecystectomy). Randomization will be achieved using a computer-generated
      list. The patient will know what are they are randomized to before entering the operating
      room because an epidural will need to be placed preoperatively. Standards for basic
      anesthetic monitoring approved by the American Society of Anesthesiologists will occur
      intraoperatively.

      Postoperative evaluations will be completed by a medical professional that is blinded to the
      type of anesthesia used during the LESS surgery. Postoperative evaluations include a physical
      exam, adverse events, medication administration, vital signs and post-anesthesia recovery
      score for ambulatory patients (PARSAP) scores will be taken every 15 minutes until the
      patient has a score of at least 18.

      Patients will be followed 90 days postoperatively to collect pain scores, analgesic use,
      adverse events, and quality of life questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Post Anesthesia Recovery Score for Ambulatory Patients
time frame: Immediately postoperative
description: PARSAP scores in the post-anesthesia recovery unit
measure: SF-12 Health survey scores
time frame: Postoperative days 1, 6, 7/8/9 or 10, 30, 90
description: scale of 12-47
measure: Pain
time frame: Immediately postoperative through postoperative day 90
description: VAS 0-10 scale
measure: Opioid requirement
time frame: Preoperative through postoperative day 90
description: Opioid use in milligrams through postoperative day 90 will be recorded.
arm group label: Group A: General Anesthesia
arm group type: Active Comparator
description: 35 patients will be randomized to receive general anesthesia during their laparoendoscopic single site incision cholecystectomy.
arm group label: Group B: Epidural Anesthesia
arm group type: Active Comparator
description: 35 patients will be randomized to receive epidural anesthesia during their laparoendoscopic single site incision cholecystectomy.
intervention type: Procedure
intervention name: General Anesthesia
description: Patients will be put under general anesthesia for cholecystectomy
arm group label: Group A: General Anesthesia
other name: IV propofol
intervention type: Procedure
intervention name: Epidural Anesthesia
description: Patients will receive Epidural Anesthesia for cholecystectomy
arm group label: Group B: Epidural Anesthesia
other name: Epidural lidocaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sharona Ross, MD
role: Principal Investigator
affiliation: Florida Hospital Tampa
last name: Alexander Rosemurgy, MD
role: Principal Investigator
affiliation: Florida Hospital Tampa
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida Hospital Tampa Bay Division
investigator full name: Alexander Rosemurgy
investigator title: Director Surgical Digestive Disorders and GERD Center
mesh term: Cholelithiasis
mesh term: Cholecystolithiasis
mesh term: Gallstones
mesh term: Lidocaine
mesh term: Anesthetics
mesh term: Propofol
sharing ipd: Undecided