<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/NCT02197988</url>
  </required_header>
  <id_info>
    <org_study_id>2013-218</org_study_id>
    <nct_id>NCT02197988</nct_id>
  </id_info>
  <brief_title>TAP Versus Thoracic Epidural in Major Abdominal Resections</brief_title>
  <official_title>Efficacy and Safety of Transversus Abdominis Plane Blocks Versus Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal Resections: A Prospective, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spectrum Health Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spectrum Health Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare two standard methods of pain control management used&#xD;
      at Spectrum Health for patients undergoing major surgery. The two methods being compared are&#xD;
      the thoracic epidural and the TAP block. The thoracic epidural method involves medication&#xD;
      being given through a patient's back and the TAP block involves medication being given&#xD;
      through a patient's abdomen (belly). The investigators will compare side effects experienced&#xD;
      by the patients that take part in this study, including a change in blood pressure, as well&#xD;
      as the patients' opinions about their pain management experience after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to compare the clinical profiles of two currently acceptable&#xD;
      analgesia techniques in terms of incidence of hypotension with subsequent fluid&#xD;
      administration and pain control by evaluation of both objective and subjective data. The&#xD;
      investigators will also compare any additional hospital costs associated with side effect&#xD;
      management related to either analgesia method.&#xD;
&#xD;
      This study is a prospective, randomized, open-label trial. Patients who agree to participate&#xD;
      and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment&#xD;
      into one of two groups (thoracic epidural or TAP block) using a randomization tool created&#xD;
      for the study.&#xD;
&#xD;
      Patients will undergo their scheduled surgery and receive the analgesic method to which they&#xD;
      have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely&#xD;
      at Spectrum Health and are considered routine care.&#xD;
&#xD;
      Data collected will include medical history and demographics from the patient's medical&#xD;
      record. Intraoperative data will include length of surgery, estimated surgical blood loss,&#xD;
      complications, blood pressure and medication requirements. Postoperative data will include&#xD;
      episodes of hypotension (defined as a systolic BP &lt; 90), fluid requirement in first 24 hours&#xD;
      and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by&#xD;
      flatus), time to tolerating a soft or regular diet, and complications. Data will also be&#xD;
      collected via a survey each study patient will complete for study purposes only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2013</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hypotension</measure>
    <time_frame>First 24-72 hours postoperatively</time_frame>
    <description>The incidence of systolic blood pressure less than 90 mmHg and fluid requirements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction relative to pain control and amount of additional narcotic usage</measure>
    <time_frame>Post operative day two during hospitalization</time_frame>
    <description>A short patient survey during the postoperative period which will collect information on pain management.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cost Evaluation</measure>
    <time_frame>Postoperative hospitalization an expected average of 6 months</time_frame>
    <description>Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Malignant Neoplasm of Abdomen</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Transversus Abdominis Plane Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thoracic Epidural Anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel 1.33% (20ml Volume)</intervention_name>
    <description>Transversus Abdominis Plane Block</description>
    <arm_group_label>Transversus Abdominis Plane Block</arm_group_label>
    <other_name>TAP Block</other_name>
    <other_name>Transversus Abdominis Plane Block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.125% bupivicaine with 2 mcg/ml Fentanyl.</intervention_name>
    <description>Thoracic Epidural Anesthesia</description>
    <arm_group_label>Thoracic Epidural Anesthesia</arm_group_label>
    <other_name>Epidural</other_name>
    <other_name>Thoracic Epidural Anesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients male or female &gt;18 years old who are scheduled to undergo a major&#xD;
             abdominal surgery. Abdominal procedures include, but are not limited to:&#xD;
             pancreaticoduodenectomies, distal pancreatectomies, bowel resection, liver resection,&#xD;
             esophagectomies, heated intraperitoneal chemotherapy, retroperitoneal excisions and&#xD;
             large genitourinary procedures&#xD;
&#xD;
          -  Patients determined by their surgeon as medically able to receive a thoracic epidural&#xD;
             or a TAP block interchangeably after consideration of both procedures&#xD;
&#xD;
          -  Patient agrees to participate in this study and provides informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Surgical cases combined with thoracic surgeries&#xD;
&#xD;
          -  Surgical cases where the abdominal operation is performed laparoscopically&#xD;
&#xD;
          -  Patients that have allergies to lidocaine, bupivacaine, levobupivacaine or&#xD;
             hydromorphone&#xD;
&#xD;
          -  Patients that are on anticoagulation or antiplatelet medications at time of surgery&#xD;
             other than aspirin&#xD;
&#xD;
          -  Surgical cases that typically do not require a regional block in addition to general&#xD;
             anesthesia (e.g., cutaneous operations)&#xD;
&#xD;
          -  Adults unable to provide informed consent&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Non-English speaking subjects&#xD;
&#xD;
          -  Any other medical condition including mental illness or substance abuse deemed by the&#xD;
             investigator to be likely to interfere with a subject's ability to provide informed&#xD;
             consent, cooperate and take part in this research study&#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>Mathew Chung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Spectrum Health Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.</citation>
    <PMID>22286518</PMID>
  </reference>
  <reference>
    <citation>Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.</citation>
    <PMID>22450529</PMID>
  </reference>
  <reference>
    <citation>Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.</citation>
    <PMID>22476239</PMID>
  </reference>
  <reference>
    <citation>Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.</citation>
    <PMID>22632762</PMID>
  </reference>
  <reference>
    <citation>Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.</citation>
    <PMID>21296242</PMID>
  </reference>
  <reference>
    <citation>Conaghan P, Maxwell-Armstrong C, Bedforth N, Gornall C, Baxendale B, Hong LL, Carty HM, Acheson AG. Efficacy of transversus abdominis plane blocks in laparoscopic colorectal resections. Surg Endosc. 2010 Oct;24(10):2480-4. doi: 10.1007/s00464-010-0989-y. Epub 2010 Apr 8.</citation>
    <PMID>20376492</PMID>
  </reference>
  <reference>
    <citation>McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.</citation>
    <PMID>17179269</PMID>
  </reference>
  <reference>
    <citation>Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.</citation>
    <PMID>22967210</PMID>
  </reference>
  <reference>
    <citation>Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.</citation>
    <PMID>22312327</PMID>
  </reference>
  <reference>
    <citation>Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.</citation>
    <PMID>14739801</PMID>
  </reference>
  <reference>
    <citation>Hilton AK, Pellegrino VA, Scheinkestel CD. Avoiding common problems associated with intravenous fluid therapy. Med J Aust. 2008 Nov 3;189(9):509-13. doi: 10.5694/j.1326-5377.2008.tb02147.x.</citation>
    <PMID>18976194</PMID>
  </reference>
  <reference>
    <citation>Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. Epub 2011 Apr 4.</citation>
    <PMID>21457153</PMID>
  </reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>May 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>April 16, 2018</last_update_submitted>
  <last_update_submitted_qc>April 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgery</keyword>
  <keyword>Abdominal</keyword>
  <keyword>Epidural Anesthesia</keyword>
  <keyword>Transversus Abdominis Plane Block</keyword>
  <keyword>TAP block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Abdominal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <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/NCT02197988
org study id: 2013-218
nct id: NCT02197988
lead sponsor: 
has dmc: No
The purpose of this study is to compare two standard methods of pain control management used
      at Spectrum Health for patients undergoing major surgery. The two methods being compared are
      the thoracic epidural and the TAP block. The thoracic epidural method involves medication
      being given through a patient's back and the TAP block involves medication being given
      through a patient's abdomen (belly). The investigators will compare side effects experienced
      by the patients that take part in this study, including a change in blood pressure, as well
      as the patients' opinions about their pain management experience after surgery.
The purpose of this study is to compare the clinical profiles of two currently acceptable
      analgesia techniques in terms of incidence of hypotension with subsequent fluid
      administration and pain control by evaluation of both objective and subjective data. The
      investigators will also compare any additional hospital costs associated with side effect
      management related to either analgesia method.

      This study is a prospective, randomized, open-label trial. Patients who agree to participate
      and satisfy the inclusion/exclusion criteria will be randomized at the time of enrollment
      into one of two groups (thoracic epidural or TAP block) using a randomization tool created
      for the study.

      Patients will undergo their scheduled surgery and receive the analgesic method to which they
      have been randomized. Both methods (thoracic epidural or TAP block) are performed routinely
      at Spectrum Health and are considered routine care.

      Data collected will include medical history and demographics from the patient's medical
      record. Intraoperative data will include length of surgery, estimated surgical blood loss,
      complications, blood pressure and medication requirements. Postoperative data will include
      episodes of hypotension (defined as a systolic BP < 90), fluid requirement in first 24 hours
      and first 72 hours, pain scores, narcotic usage, return to bowel function (as defined by
      flatus), time to tolerating a soft or regular diet, and complications. Data will also be
      collected via a survey each study patient will complete for study purposes only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hypotension
time frame: First 24-72 hours postoperatively
description: The incidence of systolic blood pressure less than 90 mmHg and fluid requirements
measure: Patient satisfaction relative to pain control and amount of additional narcotic usage
time frame: Post operative day two during hospitalization
description: A short patient survey during the postoperative period which will collect information on pain management.
measure: Cost Evaluation
time frame: Postoperative hospitalization an expected average of 6 months
description: Evaluate costs incurred relative to adverse side effect management and pain management related to either the TAP block or thoracic epidural.
arm group label: Transversus Abdominis Plane Block
arm group type: Active Comparator
description: Transversus Abdominis Plane Block Exparel 1.33% (20ml Volume)
arm group label: Thoracic Epidural Anesthesia
arm group type: Active Comparator
description: Thoracic Epidural Anesthesia 0.125% bupivicaine with 2 mcg/ml Fentanyl
intervention type: Drug
intervention name: Exparel 1.33% (20ml Volume)
description: Transversus Abdominis Plane Block
arm group label: Transversus Abdominis Plane Block
other name: TAP Block
other name: Transversus Abdominis Plane Block
intervention type: Drug
intervention name: 0.125% bupivicaine with 2 mcg/ml Fentanyl.
description: Thoracic Epidural Anesthesia
arm group label: Thoracic Epidural Anesthesia
other name: Epidural
other name: Thoracic Epidural Anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mathew Chung, MD
role: Principal Investigator
affiliation: Spectrum Health Hospitals
facility: 
country: United States
citation: Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.
PMID: 22286518
citation: Torup H, Mitchell AU, Breindahl T, Hansen EG, Rosenberg J, Moller AM. Potentially toxic concentrations in blood of total ropivacaine after bilateral transversus abdominis plane blocks; a pharmacokinetic study. Eur J Anaesthesiol. 2012 May;29(5):235-8. doi: 10.1097/EJA.0b013e328350b0d5.
PMID: 22450529
citation: Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.
PMID: 22476239
citation: Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
PMID: 22632762
citation: Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.
PMID: 21296242
citation: Conaghan P, Maxwell-Armstrong C, Bedforth N, Gornall C, Baxendale B, Hong LL, Carty HM, Acheson AG. Efficacy of transversus abdominis plane blocks in laparoscopic colorectal resections. Surg Endosc. 2010 Oct;24(10):2480-4. doi: 10.1007/s00464-010-0989-y. Epub 2010 Apr 8.
PMID: 20376492
citation: McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
PMID: 17179269
citation: Taylor R Jr, Pergolizzi JV, Sinclair A, Raffa RB, Aldington D, Plavin S, Apfel CC. Transversus abdominis block: clinical uses, side effects, and future perspectives. Pain Pract. 2013 Apr;13(4):332-44. doi: 10.1111/j.1533-2500.2012.00595.x. Epub 2013 Feb 13.
PMID: 22967210
citation: Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.
PMID: 22312327
citation: Holte K, Foss NB, Svensen C, Lund C, Madsen JL, Kehlet H. Epidural anesthesia, hypotension, and changes in intravascular volume. Anesthesiology. 2004 Feb;100(2):281-6. doi: 10.1097/00000542-200402000-00016.
PMID: 14739801
citation: Hilton AK, Pellegrino VA, Scheinkestel CD. Avoiding common problems associated with intravenous fluid therapy. Med J Aust. 2008 Nov 3;189(9):509-13. doi: 10.5694/j.1326-5377.2008.tb02147.x.
PMID: 18976194
citation: Niraj G, Kelkar A, Jeyapalan I, Graff-Baker P, Williams O, Darbar A, Maheshwaran A, Powell R. Comparison of analgesic efficacy of subcostal transversus abdominis plane blocks with epidural analgesia following upper abdominal surgery. Anaesthesia. 2011 Jun;66(6):465-71. doi: 10.1111/j.1365-2044.2011.06700.x. Epub 2011 Apr 4.
PMID: 21457153
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Abdominal Neoplasms
mesh term: Fentanyl
mesh term: Bupivacaine