<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/NCT03763760</url>
  </required_header>
  <id_info>
    <org_study_id>NBF_HK_03_2018</org_study_id>
    <nct_id>NCT03763760</nct_id>
  </id_info>
  <brief_title>High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain</brief_title>
  <official_title>High-Dose Steroids in High Pain Responders Undergoing Total Hip-arthroplasty: A Randomized Double Blinded Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sygehus Lillebaelt</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior&#xD;
      to surgery in the setting of Fast-Track Hip-surgery with Arthroplasty in a group of expected&#xD;
      High Pain Responders and the effect on postoperative pain and postoperative inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain&#xD;
      after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.&#xD;
&#xD;
      The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid&#xD;
      given as an intravenous bolus after the spinal anaesthesia has been given, but before the&#xD;
      surgery starts.&#xD;
&#xD;
      The hypothesis is that by attenuating the inflammatory response to the surgery itself by the&#xD;
      steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon&#xD;
      ambulation 24 hours after unilateral Hip Arthroplasty.&#xD;
&#xD;
      Patients referred to Unilateral Total Hip Arthroplasty because of Hip-osteoarthritis at&#xD;
      Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are&#xD;
      screened and offered inclusion in the study.&#xD;
&#xD;
      The two groups will be randomized and double blinded. One group will be treated, as the&#xD;
      current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the&#xD;
      medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).&#xD;
&#xD;
      The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg&#xD;
      bodyweight).&#xD;
&#xD;
      The patients will be monitored the first 7 days after surgery, during the admission to the&#xD;
      hospital, and by a Pain-diary in the patients own home.&#xD;
&#xD;
      Blood tests will be taken preoperatively and postoperatively to determine the effect of the&#xD;
      highdose steroid on the inflammatory response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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>A randomized double blinded controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>All intervention drugs will be blinded by a nurse who is not a participant in the study or in the treatment of the patient in any way.&#xD;
The Patient, the administrator of the drug(nurse or doctor), the assessor, the investigator and the care team will all be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain after 24 hours: VAS</measure>
    <time_frame>24 hours</time_frame>
    <description>The amount of patients with moderate postoperative pain in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.&#xD;
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS &gt;30 mm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative opioid usage</measure>
    <time_frame>7 days</time_frame>
    <description>The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative antiemetics usage</measure>
    <time_frame>7 days</time_frame>
    <description>The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The inflammatory response expressed by C-reactive protein(CRP).</measure>
    <time_frame>2 days</time_frame>
    <description>The inflammatory response is monitored by the blood-sample c-reactive protein(CRP) and analyzed to se the possible attenuation of the response because of dexamethasone.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain summarized in the first 7 days</measure>
    <time_frame>7 days</time_frame>
    <description>Pain summarized over the first 7 days after surgery, assessed by a summation of the Visual Analog Scale(VAS)-scores in the first 7 days as noted in the pain diary filed in by the participants.&#xD;
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain one can imagine. Moderate pain is considered a VAS &gt;30 mm.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward.</measure>
    <time_frame>7 days.</time_frame>
    <description>An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center.&#xD;
The questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications.&#xD;
The outcome assesment will be descriptive.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Postoperative Nausea and Vomiting</condition>
  <condition>Hip Osteoarthritis</condition>
  <condition>Perioperative/Postoperative Complications</condition>
  <condition>Surgery</condition>
  <condition>Opioid Use</condition>
  <condition>Catastrophizing Pain</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>High dose Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dose Dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>An intravenous bolus dose of dexamethasone given prior to surgery.</description>
    <arm_group_label>High dose Dexamethasone</arm_group_label>
    <arm_group_label>Medium dose Dexamethasone</arm_group_label>
    <other_name>Dexa-ratiopharm</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 40 and 90.&#xD;
&#xD;
          -  Booked for unilateral Hip-arthroplasty.&#xD;
&#xD;
          -  Is able to take part in the investigation(selfreported pain and nausea/vomiting)&#xD;
&#xD;
          -  Understands Danish or English, or has a translator available.&#xD;
&#xD;
          -  Signed written consent.&#xD;
&#xD;
          -  A daily use of 30 mg or more of morphine or morphine equivalents .&#xD;
&#xD;
          -  A pain catastrophizing scale(PCS) score of &gt;20.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insulin-dependent diabetes melitus.&#xD;
&#xD;
          -  Ongoing treatment with systemic glucocorticoids or immunosuppressing treatment(apart&#xD;
             from inhaled glucocorticoids).&#xD;
&#xD;
          -  Pregnancy/Breastfeeding&#xD;
&#xD;
          -  Allergies for the investigational drug.&#xD;
&#xD;
          -  A history of schizophrenia or bipolar diseases, or patients with permanent use of&#xD;
             antipsychotic medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolai Bang Foss, Dr.med.</last_name>
    <role>Study Director</role>
    <affiliation>Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hvidovre Hospital, Capital Region of Denmark.</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>June 29, 2021</last_update_submitted>
  <last_update_submitted_qc>June 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
    <investigator_full_name>Niklas Ingemann Nielsen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Hip Arthroplasty</keyword>
  <keyword>Hip Replacement</keyword>
  <keyword>Perioperative Medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Postoperative Complications</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>
  <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/NCT03763760
org study id: NBF_HK_03_2018
nct id: NCT03763760
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the Study is to test a higher dose of steroids(Dexamethasone) given just prior
      to surgery in the setting of Fast-Track Hip-surgery with Arthroplasty in a group of expected
      High Pain Responders and the effect on postoperative pain and postoperative inflammation.
This study compares a new High-Dose dosage of steroids in the treatment of postoperative pain
      after Hip Arthroplasty in a Fast-Track setting in a group of expected High Pain Responders.

      The investigators compare the already used dose(medium dose) with a new high dose(HD) steroid
      given as an intravenous bolus after the spinal anaesthesia has been given, but before the
      surgery starts.

      The hypothesis is that by attenuating the inflammatory response to the surgery itself by the
      steroid Dexamethasone, the investigators expect a reduction in postoperative pain upon
      ambulation 24 hours after unilateral Hip Arthroplasty.

      Patients referred to Unilateral Total Hip Arthroplasty because of Hip-osteoarthritis at
      Hvidovre Hospital, Capital Region of Denmark or Vejle Hospital, South Region of Denmark are
      screened and offered inclusion in the study.

      The two groups will be randomized and double blinded. One group will be treated, as the
      current guideline in the investigator's Orthopedic fast-track Arthroplasty center, with the
      medium dose of steroid (0,3 mg dexamethasone/kg bodyweight).

      The other group wil be treated with a high dose of steroid (1,0 mg dexamethasone/kg
      bodyweight).

      The patients will be monitored the first 7 days after surgery, during the admission to the
      hospital, and by a Pain-diary in the patients own home.

      Blood tests will be taken preoperatively and postoperatively to determine the effect of the
      highdose steroid on the inflammatory response.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized double blinded controlled trial.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: All intervention drugs will be blinded by a nurse who is not a participant in the study or in the treatment of the patient in any way.
The Patient, the administrator of the drug(nurse or doctor), the assessor, the investigator and the care team will all be blinded.
measure: Postoperative pain after 24 hours: VAS
time frame: 24 hours
description: The amount of patients with moderate postoperative pain in a 5 meter walk test 24 hours postoperatively after total knee-arthroplasty.
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain. Moderate pain is considered a VAS >30 mm.
measure: Postoperative opioid usage
time frame: 7 days
description: The amount of rescue opioids given in the postoperative period, and until 7 days after surgery.
measure: Postoperative antiemetics usage
time frame: 7 days
description: The amount of rescue antiemetics given in the postoperative period, and until 7 days after surgery.
measure: The inflammatory response expressed by C-reactive protein(CRP).
time frame: 2 days
description: The inflammatory response is monitored by the blood-sample c-reactive protein(CRP) and analyzed to se the possible attenuation of the response because of dexamethasone.
measure: Postoperative pain summarized in the first 7 days
time frame: 7 days
description: Pain summarized over the first 7 days after surgery, assessed by a summation of the Visual Analog Scale(VAS)-scores in the first 7 days as noted in the pain diary filed in by the participants.
Pain is monitored by the Visual Analog Scale(VAS) 0-100 mm, where 0 is no pain and 100 mm is the worst pain one can imagine. Moderate pain is considered a VAS >30 mm.
measure: Why still in hospital, an audit into the reasons the patient has not yet been discharged from the ward.
time frame: 7 days.
description: An investigation into reason of why our patients remain in the hospital in the days after total Knee Arthroplasty in our Fast-Track center. This is investigated through a questionnaire previously used in a similar investigation in our center.
The questionnaire is filled in by our project nurse. the questionnaire is a checkmark schedule with predetermined reasons to stay in hospital like low bloodpressure, sedation, dizzyness, lack of physiotherapy and medical and surgical complications.
The outcome assesment will be descriptive.
arm group label: High dose Dexamethasone
arm group type: Experimental
description: An intravenous bolus dose of Dexamethasone 1 mg/kg bodyweight administered preoperatively before surgery.
arm group label: Medium dose Dexamethasone
arm group type: Active Comparator
description: An intravenous bolus dose of Dexamethasone 0,3 mg/kg bodyweight administered preoperatively before surgery.
intervention type: Drug
intervention name: Dexamethasone
description: An intravenous bolus dose of dexamethasone given prior to surgery.
arm group label: High dose Dexamethasone
arm group label: Medium dose Dexamethasone
other name: Dexa-ratiopharm
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Nicolai Bang Foss, Dr.med.
role: Study Director
affiliation: Dept. of Anaesthesia, Hvidovre Hospital, Capital Region of Denmark.
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Niklas Ingemann Nielsen
investigator title: Principal Investigator
mesh term: Osteoarthritis, Hip
mesh term: Pain, Postoperative
mesh term: Chronic Pain
mesh term: Vomiting
mesh term: Postoperative Complications
mesh term: Postoperative Nausea and Vomiting
mesh term: Dexamethasone
sharing ipd: No