<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/NCT03792295</url>
  </required_header>
  <id_info>
    <org_study_id>MultimodalHernia</org_study_id>
    <nct_id>NCT03792295</nct_id>
  </id_info>
  <brief_title>Multimodal Pain Therapy After Hernia Repair</brief_title>
  <official_title>The Effect of Multimodal Pain Therapy After Hernia Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khashayar Vaziri</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigating the effect of multimodal pain treatment after hernia repair&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, non-blinded study comparing the effects of multimodal pain management&#xD;
      (ibuprofen, tylenol, and narcotics/oxycodone as needed) for relief of post-operative pain in&#xD;
      patients who undergo hernia repair. Patients who present for elective hernia surgery will be&#xD;
      randomized in a 1:1 fashion by pre-operative pain score into a multimodal pain treatment&#xD;
      group or conventional opiod treatment group for post-operative pain management. They will be&#xD;
      followed up after their surgery to evaluate their pain scores and narcotic use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    no enrollment, reallocation of resources&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2021</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative pain scores at rest and during movement</measure>
    <time_frame>1-14 days after surgery</time_frame>
    <description>Patients will be called on post operative days 1-3 and asked to rate their pain while at rest and during movement using the following scales:&#xD;
On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during REST? 1 2 3 4 5 6 7 8 9 10&#xD;
On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during MOVEMENT (such as walking across the room)? 1 2 3 4 5 6 7 8 9 10&#xD;
Patients will also be asked the same two pain scales (pain at rest and during movement) at the first post-operative appointment, which will occur within 14 days of their surgery.&#xD;
The scores for pain at rest and during movement will not be summed or averaged together, so that the maximum score on each scale is 10 (worst pain), and the minimum score is 1 (no pain). Scores will not be summed across days. Lower scores are considered a better outcome, and higher scores are considered a worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Narcotic use</measure>
    <time_frame>1-14 days after surgery</time_frame>
    <description>Amount of oxycodone pills taken</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hernia, Abdominal</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Multimodal Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive scheduled ibuprofen 400mg po q 4 hours and acetominophen 1gram po q 8 hours during the post operative phase and oxycodone 5mg po q 4 to 6 hours as needed for pain control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Classic/standard opiod Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetominophen, ibuprofen, oxycodone</intervention_name>
    <description>Multimodal pain treatment group</description>
    <arm_group_label>Multimodal Therapy</arm_group_label>
    <other_name>Tylenol, Advil, OxyContin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>Classic opiod pain treatment group</description>
    <arm_group_label>Classic/standard opiod Therapy</arm_group_label>
    <other_name>OxyContin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult patients &gt;18 years of age to 90 years of age who are eligible for a&#xD;
             hernia repair (ventral or inguinal) by a surgeon in the Medical Faculty Associates&#xD;
             Department of General Surgery at the George Washington University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with allergies to sulfa or any of the medications being evaluated in this&#xD;
             study (ibuprofen, tylenol, oxycodone)&#xD;
&#xD;
          -  patients with a history of gastric ulcer or gastrointestinal bleeding&#xD;
&#xD;
          -  patients with kidney disease&#xD;
&#xD;
          -  patients with cardiovascular disease&#xD;
&#xD;
          -  patients with a co-morbid condition that would prohibit them from taking narcotics&#xD;
&#xD;
          -  patients with known or suspected narcotic abuse&#xD;
&#xD;
          -  patients who do not wish to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>George Washington University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.</citation>
    <PMID>28033313</PMID>
  </reference>
  <reference>
    <citation>Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.</citation>
    <PMID>28403427</PMID>
  </reference>
  <reference>
    <citation>Manworren RC. Multimodal pain management and the future of a personalized medicine approach to pain. AORN J. 2015 Mar;101(3):308-14; quiz 315-8. doi: 10.1016/j.aorn.2014.12.009.</citation>
    <PMID>25707723</PMID>
  </reference>
  <reference>
    <citation>Warren JA, Stoddard C, Hunter AL, Horton AJ, Atwood C, Ewing JA, Pusker S, Cancellaro VA, Walker KB, Cobb WS, Carbonell AM, Morgan RR. Effect of Multimodal Analgesia on Opioid Use After Open Ventral Hernia Repair. J Gastrointest Surg. 2017 Oct;21(10):1692-1699. doi: 10.1007/s11605-017-3529-4. Epub 2017 Aug 14.</citation>
    <PMID>28808868</PMID>
  </reference>
  <reference>
    <citation>Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of Multimodal Enhanced Recovery Pathway in Patients Undergoing Open Ventral Hernia Repair. J Am Coll Surg. 2016 Jun;222(6):1106-15. doi: 10.1016/j.jamcollsurg.2016.02.015. Epub 2016 Mar 3.</citation>
    <PMID>27049780</PMID>
  </reference>
  <reference>
    <citation>Fayezizadeh M, Petro CC, Rosen MJ, Novitsky YW. Enhanced recovery after surgery pathway for abdominal wall reconstruction: pilot study and preliminary outcomes. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):151S-159S. doi: 10.1097/PRS.0000000000000674.</citation>
    <PMID>25254998</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Khashayar Vaziri</investigator_full_name>
    <investigator_title>Associate Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Abdominal</mesh_term>
    <mesh_term>Internal Hernia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03792295
org study id: MultimodalHernia
nct id: NCT03792295
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Investigating the effect of multimodal pain treatment after hernia repair
This is a randomized, non-blinded study comparing the effects of multimodal pain management
      (ibuprofen, tylenol, and narcotics/oxycodone as needed) for relief of post-operative pain in
      patients who undergo hernia repair. Patients who present for elective hernia surgery will be
      randomized in a 1:1 fashion by pre-operative pain score into a multimodal pain treatment
      group or conventional opiod treatment group for post-operative pain management. They will be
      followed up after their surgery to evaluate their pain scores and narcotic use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post operative pain scores at rest and during movement
time frame: 1-14 days after surgery
description: Patients will be called on post operative days 1-3 and asked to rate their pain while at rest and during movement using the following scales:
On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during REST? 1 2 3 4 5 6 7 8 9 10
On a scale of 1-10, with 1=no pain and 10= the worst pain, what has been your average pain level since surgery during MOVEMENT (such as walking across the room)? 1 2 3 4 5 6 7 8 9 10
Patients will also be asked the same two pain scales (pain at rest and during movement) at the first post-operative appointment, which will occur within 14 days of their surgery.
The scores for pain at rest and during movement will not be summed or averaged together, so that the maximum score on each scale is 10 (worst pain), and the minimum score is 1 (no pain). Scores will not be summed across days. Lower scores are considered a better outcome, and higher scores are considered a worse outcome.
measure: Narcotic use
time frame: 1-14 days after surgery
description: Amount of oxycodone pills taken
arm group label: Multimodal Therapy
arm group type: Experimental
description: Patients will receive scheduled ibuprofen 400mg po q 4 hours and acetominophen 1gram po q 8 hours during the post operative phase and oxycodone 5mg po q 4 to 6 hours as needed for pain control.
arm group label: Classic/standard opiod Therapy
arm group type: Active Comparator
description: Patients will receive oxycodone 5mg po q 4 to 6 hours as needed during their post operative phase for pain control.
intervention type: Drug
intervention name: acetominophen, ibuprofen, oxycodone
description: Multimodal pain treatment group
arm group label: Multimodal Therapy
other name: Tylenol, Advil, OxyContin
intervention type: Drug
intervention name: Oxycodone
description: Classic opiod pain treatment group
arm group label: Classic/standard opiod Therapy
other name: OxyContin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths - United States, 2010-2015. MMWR Morb Mortal Wkly Rep. 2016 Dec 30;65(50-51):1445-1452. doi: 10.15585/mmwr.mm655051e1.
PMID: 28033313
citation: Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272.
PMID: 28403427
citation: Manworren RC. Multimodal pain management and the future of a personalized medicine approach to pain. AORN J. 2015 Mar;101(3):308-14; quiz 315-8. doi: 10.1016/j.aorn.2014.12.009.
PMID: 25707723
citation: Warren JA, Stoddard C, Hunter AL, Horton AJ, Atwood C, Ewing JA, Pusker S, Cancellaro VA, Walker KB, Cobb WS, Carbonell AM, Morgan RR. Effect of Multimodal Analgesia on Opioid Use After Open Ventral Hernia Repair. J Gastrointest Surg. 2017 Oct;21(10):1692-1699. doi: 10.1007/s11605-017-3529-4. Epub 2017 Aug 14.
PMID: 28808868
citation: Majumder A, Fayezizadeh M, Neupane R, Elliott HL, Novitsky YW. Benefits of Multimodal Enhanced Recovery Pathway in Patients Undergoing Open Ventral Hernia Repair. J Am Coll Surg. 2016 Jun;222(6):1106-15. doi: 10.1016/j.jamcollsurg.2016.02.015. Epub 2016 Mar 3.
PMID: 27049780
citation: Fayezizadeh M, Petro CC, Rosen MJ, Novitsky YW. Enhanced recovery after surgery pathway for abdominal wall reconstruction: pilot study and preliminary outcomes. Plast Reconstr Surg. 2014 Oct;134(4 Suppl 2):151S-159S. doi: 10.1097/PRS.0000000000000674.
PMID: 25254998
responsible party type: Sponsor-Investigator
investigator affiliation: George Washington University
investigator full name: Khashayar Vaziri
investigator title: Associate Professor of Surgery
mesh term: Hernia
mesh term: Hernia, Abdominal
mesh term: Internal Hernia
mesh term: Acetaminophen
mesh term: Ibuprofen
mesh term: Oxycodone
sharing ipd: No