<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/NCT04432259</url>
  </required_header>
  <id_info>
    <org_study_id>13565</org_study_id>
    <nct_id>NCT04432259</nct_id>
  </id_info>
  <brief_title>Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty</brief_title>
  <official_title>Oral Dexamethasone as an Intervention for Postoperative Pain and Nausea Management in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine if oral dexamethasone provides clinically significant&#xD;
      improvement in postoperative outcomes, specifically nausea and pain scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Protocols in perioperative pain management during total joint arthroplasty (TJA) have&#xD;
      contributed to early discharge after surgery. As practices move to favor ambulatory surgery&#xD;
      in total joint arthroplasty changes must be made to postoperative pain and nausea management.&#xD;
      Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea&#xD;
      and vomiting are known detrimental side effects. The use of systemic steroids has also been&#xD;
      shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and&#xD;
      increase the distance of ambulation without increasing the rate of surgical site infection or&#xD;
      prosthetic joint infection. As more same-day total joint replacement is incorporated into&#xD;
      practice, an oral alternative may prove beneficial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>3 weeks following surgery</time_frame>
    <description>Postoperative pain will be collected via visual analog scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Nausea</measure>
    <time_frame>3 weeks following surgery</time_frame>
    <description>Postoperative Nausea will be collected via visual analog scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Opioid Consumption</measure>
    <time_frame>6 months</time_frame>
    <description>Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Antiemetic Consumption</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Episodes of Nausea</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>6 months</time_frame>
    <description>Incidence of surgical site infection, acute prosthetic joint infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported outcome scores (PROMS)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Injury and Osteoarthritis Outcome Score (KOOS)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Arthritis Knee</condition>
  <condition>Postoperative Nausea</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Arm B: Oral Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm A: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>4 mg bid for 4 days</description>
    <arm_group_label>Arm B: Oral Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral placebo</description>
    <arm_group_label>Arm A: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients age 18 and older who will be undergoing joint replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled diabetes ( HbA1C, &gt;7.5%), impaired hepatic function (Child&#xD;
             class, &gt;B), impaired renal failure (Glomerular filtration rate &lt;60 mL/min/1.73 m2),&#xD;
             chronic narcotic use, alcohol and/or opioid dependence, patients with a known adverse&#xD;
             reaction to corticosteroids, and patients unable to give informed consent.&#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>Jason Davis, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jonathan Shaw, M.D.</last_name>
    <phone>414-405-8544</phone>
    <email>jshaw5@hfhs.org</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Jonathan H. Shaw</investigator_full_name>
    <investigator_title>Orthopaedic Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</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/NCT04432259
org study id: 13565
nct id: NCT04432259
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to determine if oral dexamethasone provides clinically significant
      improvement in postoperative outcomes, specifically nausea and pain scores.
Protocols in perioperative pain management during total joint arthroplasty (TJA) have
      contributed to early discharge after surgery. As practices move to favor ambulatory surgery
      in total joint arthroplasty changes must be made to postoperative pain and nausea management.
      Spinal anesthesia has been essential in managing associated ambulatory TJA, however, nausea
      and vomiting are known detrimental side effects. The use of systemic steroids has also been
      shown in the literature to reduce pain scores, length of stay, the need for antiemetics, and
      increase the distance of ambulation without increasing the rate of surgical site infection or
      prosthetic joint infection. As more same-day total joint replacement is incorporated into
      practice, an oral alternative may prove beneficial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly assigned to one of two groups, treatment or no treatment. Randomizations will be balanced at random accrual points.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postoperative Pain
time frame: 3 weeks following surgery
description: Postoperative pain will be collected via visual analog scores
measure: Postoperative Nausea
time frame: 3 weeks following surgery
description: Postoperative Nausea will be collected via visual analog scores
measure: Opioid Consumption
time frame: 6 months
description: Opioid consumption will be recorded by participant in assigned journal, morphine equivalence will be recorded
measure: Antiemetic Consumption
time frame: 6 months
measure: Episodes of Nausea
time frame: 3 weeks
measure: Postoperative complications
time frame: 6 months
description: Incidence of surgical site infection, acute prosthetic joint infection
measure: Patient-reported outcome scores (PROMS)
time frame: 6 months
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
time frame: 6 months
arm group label: Arm B: Oral Dexamethasone
arm group type: Experimental
description: Participants will be randomly assigned to receive 4 mg Oral Dexamethasone taken twice daily for 4 days
arm group label: Arm A: Placebo
arm group type: Placebo Comparator
description: Participants will be randomly assigned to receive 4 mg placebo taken twice daily for 4 days
intervention type: Drug
intervention name: Dexamethasone
description: 4 mg bid for 4 days
arm group label: Arm B: Oral Dexamethasone
intervention type: Drug
intervention name: Placebo
description: oral placebo
arm group label: Arm A: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jason Davis, M.D.
role: Principal Investigator
affiliation: Henry Ford Health System
last name: Jonathan Shaw, M.D.
phone: 414-405-8544
email: jshaw5@hfhs.org
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Jonathan H. Shaw
investigator title: Orthopaedic Surgeon
mesh term: Pain, Postoperative
mesh term: Nausea
mesh term: Postoperative Nausea and Vomiting
mesh term: Dexamethasone