<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/NCT03817034</url>
  </required_header>
  <id_info>
    <org_study_id>2018P002053</org_study_id>
    <nct_id>NCT03817034</nct_id>
  </id_info>
  <brief_title>Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption</brief_title>
  <official_title>Multimodal Analgesia for the Reduction of Postoperative Opioid Consumption</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <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>
      The investigators are performing this research study to investigate the efficacy of local&#xD;
      infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac&#xD;
      (treatment group) versus the current standard of care (historical control group), for&#xD;
      post-operative pain management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During this research study, patients recommended for a rectus sheath block during surgery&#xD;
      will receive a novel combination of non-opioid drugs. Data from the treatment group will be&#xD;
      compared to surgical outcomes of a historically matched control group to investigate the&#xD;
      ability of this drug combination to reduce post-operative pain and post-operative opioid&#xD;
      consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We decided to close this study and come up with a new study design.&#xD;
  </why_stopped>
  <start_date type="Actual">March 11, 2021</start_date>
  <completion_date type="Actual">March 11, 2021</completion_date>
  <primary_completion_date type="Actual">March 11, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in post-operative opioid consumption</measure>
    <time_frame>48 hours</time_frame>
    <description>Decreased post-operative opioid consumption associated with use of multimodal analgesia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in post-operative pain scores</measure>
    <time_frame>48 hours</time_frame>
    <description>Decreased post-operative pain scores associated with use of multimodal analgesia</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Multimodal Analgesia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multimodal analgesia</intervention_name>
    <description>Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac</description>
    <arm_group_label>Multimodal Analgesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years&#xD;
&#xD;
          -  American Society of Anesthesiologist Physical Status Classification 1-3&#xD;
&#xD;
          -  Undergoing surgery requiring a rectus sheath block&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologist Physical Status Classification of 4 or beyond&#xD;
&#xD;
          -  history of opiate of illicit substance abuse, chronic pain, or neurological&#xD;
             dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emery N Brown, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>March 28, 2021</last_update_submitted>
  <last_update_submitted_qc>March 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Emery Brown</investigator_full_name>
    <investigator_title>Director, Neuroscience Statistics Research Laboratory</investigator_title>
  </responsible_party>
  <keyword>multimodal</keyword>
  <keyword>dexmedetomidine</keyword>
  <keyword>ropivacaine</keyword>
  <keyword>ketorolac</keyword>
  <keyword>pain management</keyword>
  <keyword>opioid sparing</keyword>
  <keyword>analgesia</keyword>
  <!-- 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/NCT03817034
org study id: 2018P002053
nct id: NCT03817034
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The investigators are performing this research study to investigate the efficacy of local
      infiltration of the surgical wound combining dexmedetomidine, ropivacaine, and ketorolac
      (treatment group) versus the current standard of care (historical control group), for
      post-operative pain management.
During this research study, patients recommended for a rectus sheath block during surgery
      will receive a novel combination of non-opioid drugs. Data from the treatment group will be
      compared to surgical outcomes of a historically matched control group to investigate the
      ability of this drug combination to reduce post-operative pain and post-operative opioid
      consumption.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in post-operative opioid consumption
time frame: 48 hours
description: Decreased post-operative opioid consumption associated with use of multimodal analgesia
measure: Change in post-operative pain scores
time frame: 48 hours
description: Decreased post-operative pain scores associated with use of multimodal analgesia
arm group label: Multimodal Analgesia
arm group type: Experimental
intervention type: Drug
intervention name: Multimodal analgesia
description: Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac
arm group label: Multimodal Analgesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Emery N Brown, M.D., Ph.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Emery Brown
investigator title: Director, Neuroscience Statistics Research Laboratory