<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/NCT03011905</url>
  </required_header>
  <id_info>
    <org_study_id>2016/599/REK sør-øst C</org_study_id>
    <nct_id>NCT03011905</nct_id>
  </id_info>
  <brief_title>Rebound Pain After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block</brief_title>
  <official_title>Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many patients have strong pain at brachial plexus block resolution after operations for&#xD;
      distal radius fractures with a volar plate. This study investigates if a single dose of&#xD;
      dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The&#xD;
      primary endpoint is difference in the highest pain score first 24 hours after surgery. The&#xD;
      investigators will also look at pain scores and analgesics consumption first few hours after&#xD;
      surgery and at different times up to 2 years after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This double-blind randomized clinical study evaluates pain, analgesic consumption and&#xD;
      different measurements of patients satisfaction after operations for distal radius fractures&#xD;
      with a volar plate in the day-care surgery unit. All patients will receive paracetamol and&#xD;
      etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial&#xD;
      plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a&#xD;
      single dose of 16 mg dexamethasone during the operation. Patients in the control group will&#xD;
      receive NaCl iv.&#xD;
&#xD;
      After surgery, iv and oral rapid release oxycodone as needed while in hospital. After&#xD;
      discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3&#xD;
      doses. Rapid release oxycodone as needed.&#xD;
&#xD;
      Patients will be followed up by telephone interviews at different times after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">April 5, 2020</completion_date>
  <primary_completion_date type="Actual">April 5, 2019</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Differences between groups in highest pain scores first 24 hours after surgery</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours</measure>
    <time_frame>30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks</measure>
    <time_frame>36 hours, 3 days, 7 days, 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in pain scores after 6 months and 1 year</measure>
    <time_frame>6 months and 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in analgesic consumption</measure>
    <time_frame>1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in block duration</measure>
    <time_frame>20 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between groups in sedation postoperatively assessed with Likert scale</measure>
    <time_frame>30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between groups in sleep quality assessed with Likert scale</measure>
    <time_frame>24 hours</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between groups in nausea postoperatively assessed with Likert scale</measure>
    <time_frame>30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between groups in vomiting postoperatively assessed with Likert scale</measure>
    <time_frame>30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences between groups in itching postoperatively assessed with Likert scale</measure>
    <time_frame>30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours</time_frame>
    <description>Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in time to first pain score under 4 after block resolution</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in side effects</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Brachial Plexus Block</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of NaCl, 4 ml, iv during operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>4 ml DexaGalen 4 mg/ml</description>
    <arm_group_label>Dexamethasone</arm_group_label>
    <other_name>DexaGalen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NaCl (Control)</intervention_name>
    <description>4 ml NaCl 9 mg/ml</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>NaCl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <description>Premedication and as needed after operation</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EtoriCoxib</intervention_name>
    <description>Premedication and first 2 postoperative days.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Dexamethasone</arm_group_label>
    <other_name>Arcoxia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Dexamethasone</arm_group_label>
    <other_name>OxyContin</other_name>
    <other_name>OxyNorm</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>In brachial plexus block</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Distal radius fracture planned for operation with a volar plate&#xD;
&#xD;
          -  0-20 days after trauma&#xD;
&#xD;
          -  AO classification A, B, and C&#xD;
&#xD;
          -  ASA 1 and 2&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  BMI 18-35&#xD;
&#xD;
          -  Able to communicate in Norwegian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  Other injuries&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Known allergic reactions to medicines used in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Holmberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo Universitetssykehus, Ullevaal, dept of anaesthesiology, legevakten</name>
      <address>
        <city>Oslo</city>
        <zip>0540</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>September 18, 2020</last_update_submitted>
  <last_update_submitted_qc>September 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Anne Holmberg</investigator_full_name>
    <investigator_title>Principal investigator</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>Radius Fractures</mesh_term>
    <mesh_term>Wrist Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Etoricoxib</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
    <mesh_term>Ropivacaine</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/NCT03011905
org study id: 2016/599/REK sør-øst C
nct id: NCT03011905
lead sponsor: 
has dmc: No
Many patients have strong pain at brachial plexus block resolution after operations for
      distal radius fractures with a volar plate. This study investigates if a single dose of
      dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The
      primary endpoint is difference in the highest pain score first 24 hours after surgery. The
      investigators will also look at pain scores and analgesics consumption first few hours after
      surgery and at different times up to 2 years after surgery.
This double-blind randomized clinical study evaluates pain, analgesic consumption and
      different measurements of patients satisfaction after operations for distal radius fractures
      with a volar plate in the day-care surgery unit. All patients will receive paracetamol and
      etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial
      plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a
      single dose of 16 mg dexamethasone during the operation. Patients in the control group will
      receive NaCl iv.

      After surgery, iv and oral rapid release oxycodone as needed while in hospital. After
      discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3
      doses. Rapid release oxycodone as needed.

      Patients will be followed up by telephone interviews at different times after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Differences between groups in highest pain scores first 24 hours after surgery
time frame: 24 hours
measure: Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours
measure: Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks
time frame: 36 hours, 3 days, 7 days, 6 weeks
measure: Differences in pain scores after 6 months and 1 year
time frame: 6 months and 1 year
measure: Differences in analgesic consumption
time frame: 1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year
measure: Differences in block duration
time frame: 20 hours
measure: Differences between groups in sedation postoperatively assessed with Likert scale
time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
description: Likert scale
measure: Differences between groups in sleep quality assessed with Likert scale
time frame: 24 hours
description: Likert scale
measure: Differences between groups in nausea postoperatively assessed with Likert scale
time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
description: Likert scale
measure: Differences between groups in vomiting postoperatively assessed with Likert scale
time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
description: Likert scale
measure: Differences between groups in itching postoperatively assessed with Likert scale
time frame: 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours
description: Likert scale
measure: Differences in time to first pain score under 4 after block resolution
time frame: 7 days
measure: Differences in side effects
time frame: 1 year
measure: Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks
time frame: 6 weeks
arm group label: Dexamethasone
arm group type: Experimental
description: Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
arm group label: Control
arm group type: Placebo Comparator
description: Single dose of NaCl, 4 ml, iv during operation.
intervention type: Drug
intervention name: Dexamethasone
description: 4 ml DexaGalen 4 mg/ml
arm group label: Dexamethasone
other name: DexaGalen
intervention type: Drug
intervention name: NaCl (Control)
description: 4 ml NaCl 9 mg/ml
arm group label: Control
other name: NaCl
intervention type: Drug
intervention name: Paracetamol
description: Premedication and as needed after operation
arm group label: Control
arm group label: Dexamethasone
intervention type: Drug
intervention name: EtoriCoxib
description: Premedication and first 2 postoperative days.
arm group label: Control
arm group label: Dexamethasone
other name: Arcoxia
intervention type: Drug
intervention name: Oxycodone
description: Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
arm group label: Control
arm group label: Dexamethasone
other name: OxyContin
other name: OxyNorm
intervention type: Drug
intervention name: Ropivacaine
description: In brachial plexus block
arm group label: Control
arm group label: Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Anne Holmberg, MD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Anne Holmberg
investigator title: Principal investigator
mesh term: Pain, Postoperative
mesh term: Radius Fractures
mesh term: Wrist Fractures
mesh term: Acetaminophen
mesh term: Dexamethasone
mesh term: Etoricoxib
mesh term: Oxycodone
mesh term: Ropivacaine
sharing ipd: No