<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/NCT03749174</url>
  </required_header>
  <id_info>
    <org_study_id>RADAR</org_study_id>
    <nct_id>NCT03749174</nct_id>
  </id_info>
  <brief_title>Radius Fracture Anesthesia and Rehabilitation (RADAR)</brief_title>
  <acronym>RADAR</acronym>
  <official_title>Radius Fracture Anesthesia and Rehabilitation (RADAR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Distal fracture of the radial bone is the commonest fracture and is also connected to&#xD;
      osteoporosis. Normally the operation is performed under neuroaxial blockade and sedation.&#xD;
      When the blockade rapidly vanish many patients experience a rebound pain much severer that&#xD;
      than the actual trauma pain. If long acting local anesthetics are used this will occur during&#xD;
      night time and many patients will go to the emergency room for pain treatment. Short acting&#xD;
      local anesthetics may make it possible to treat patients pain in-house prior to leaving the&#xD;
      hospital. In this study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This investigation is a joint study involving Occupational Therapist, Orthopedic surgeons and&#xD;
      Anesthesiologist. Distal fracture of the radial bone is the commonest fracture, mainly in&#xD;
      elder females with osteoporosis and also obesity. Normally 75% of patients are treated with&#xD;
      plaster after fracture repositioning. The remaining 25% are operated upon. Routinely, the&#xD;
      operation is performed under neuroaxial blockade and sedation. When the blockade rapidly&#xD;
      vanish many patients experience a rebound pain much severer than the initial trauma pain. If&#xD;
      long acting local anesthetics are used the blockade will be terminated during night and many&#xD;
      patients will go to the Emergency room for pain treatment. Short acting local anesthetics may&#xD;
      make it possible to treat patients pain in-house prior to hospital discharge and thus reduce&#xD;
      severe rebound pain.&#xD;
&#xD;
      In this study patients with radial fractures are included and operated upon by a standard&#xD;
      surgical operation with plate and screws. They will receive either 1) ultra sound guided&#xD;
      supraclavicular block long-acting (n=30) local anesthetic , 2) ultra sound guided&#xD;
      supraclavicular block short-acing (n=60) local anesthetics or 3) general anesthesia (n=30) to&#xD;
      provide analgesia during the operational procedure. Patients given an ultra sound guided&#xD;
      blockade with short-acting local anesthetic (n=60) are further sub-divided into receiving&#xD;
      either postoperative plaster/cast (n=30) or an orthosis/brace (n=30).&#xD;
&#xD;
      Patients pain will be measured by Numeric Rating scale (0 = no pain and 10 worst possible&#xD;
      pain) during the first 7 postoperative days. The opioid consumption will be noted by personal&#xD;
      contact intermittently by telephone and by a pain diary until day 7. Both parametric and&#xD;
      none-parametric analysis will be conducted.&#xD;
&#xD;
      Quality of recovery will be assessed by Quality of Recovery Scale 15 at 5 occasions. Adverse&#xD;
      effects and unplanned health care contacts will also be gathered.&#xD;
&#xD;
      After 3 days the Occupational Therapist will control the patients followed by investigations&#xD;
      at 2, 6 12 and 52 weeks. The patients will be graded the Patient rated Wrist Evaluation&#xD;
      (PRWE) and Michigan Outcomes Questionnaire (MHQ) Edema will be measured and strength will be&#xD;
      measured by Jamar dynamometer, Finally, Sense of coherence will be measured by KASAM-13&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2018</start_date>
  <completion_date type="Actual">June 20, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Patients are subdivided into 3 groups where one group is further subdivided into 2 groups</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rebound pain, difference in pain (NRS) at rest at 24-hours and further during the first three days after surgery between short acting block (mepivacaine) and long acting block (ropivacaine), with General Anesthesia being control group.</measure>
    <time_frame>72 hours</time_frame>
    <description>Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Recovery; difference in sum median and its five domains of QoR-15 score at baseline, 24 hours, 72 hours and 7 days after surgery between the two groups cast and orthosis/brace. - Anesthesiology part 2</measure>
    <time_frame>1st three postoperative days</time_frame>
    <description>Quality of Recovery scale 15 assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post surgery arm function - Occupational therapist</measure>
    <time_frame>12 months</time_frame>
    <description>Influence of immobilization by plaster or orthosis/brace</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post surgery opioid requirement - Anesthesiology part</measure>
    <time_frame>day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)</time_frame>
    <description>daily opioid requirement mg dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perioperative time events - Anesthesiology part</measure>
    <time_frame>perioperatively</time_frame>
    <description>Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Nausea and Vomiting - Anesthesiology part</measure>
    <time_frame>up to 72 hours post surgery</time_frame>
    <description>Any experience of PONV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned health care contact - Anesthesiology part</measure>
    <time_frame>1st postoperative week</time_frame>
    <description>any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post surgery arm status 1 - Occupational therapist</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post surgery arm status 2 - Occupational therapist</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post surgery arm status 3 - Occupational therapist</measure>
    <time_frame>12 months</time_frame>
    <description>Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Radial Fracture</condition>
  <arm_group>
    <arm_group_label>Long acting anesthetic block/plaster</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short acting anesthetic block/plaster</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short acting anesthetic block/orthotic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General Anesthesia and plaster</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30),</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Long acting Supraclivicular block vs Short acting Supraclavicular block</intervention_name>
    <description>Patients are randomized to receive; long-acting Supraclavicular plexus block or short-acting Supraclavicular plexus block or general anesthesia&#xD;
Sub group randomized to plaster/cast or orthosis/brace, both having short-acting block</description>
    <arm_group_label>General Anesthesia and plaster</arm_group_label>
    <arm_group_label>Long acting anesthetic block/plaster</arm_group_label>
    <arm_group_label>Short acting anesthetic block/orthotic</arm_group_label>
    <arm_group_label>Short acting anesthetic block/plaster</arm_group_label>
    <other_name>Long acting anesthetic block/plaster</other_name>
    <other_name>Short acting anesthetic block/plaster</other_name>
    <other_name>Short acting anesthetic block/orthosis</other_name>
    <other_name>General Anesthesia and plaster</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Understands native language&#xD;
&#xD;
          -  Cognitive intact&#xD;
&#xD;
          -  Fracture types AO 23..A and AO 23.C.1&#xD;
&#xD;
          -  Operated within 18 days from initial trauma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not fulfilling inclusion criterias&#xD;
&#xD;
          -  High energy trauma&#xD;
&#xD;
          -  Ligament injury&#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>Bengt Nellgard, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Göteborg University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SahlgrenskaUH</name>
      <address>
        <city>Molndal</city>
        <state>VGR</state>
        <zip>43180</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.</citation>
    <PMID>26869374</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>October 26, 2022</last_update_submitted>
  <last_update_submitted_qc>October 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Bengt Nellgård</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Radial fracture</keyword>
  <keyword>Anesthetic</keyword>
  <keyword>Plaster</keyword>
  <keyword>Cast</keyword>
  <keyword>Orthosis</keyword>
  <keyword>Brace</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>Quality of Recovery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Radius Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT03749174
org study id: RADAR
nct id: NCT03749174
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Distal fracture of the radial bone is the commonest fracture and is also connected to
      osteoporosis. Normally the operation is performed under neuroaxial blockade and sedation.
      When the blockade rapidly vanish many patients experience a rebound pain much severer that
      than the actual trauma pain. If long acting local anesthetics are used this will occur during
      night time and many patients will go to the emergency room for pain treatment. Short acting
      local anesthetics may make it possible to treat patients pain in-house prior to leaving the
      hospital. In this study
This investigation is a joint study involving Occupational Therapist, Orthopedic surgeons and
      Anesthesiologist. Distal fracture of the radial bone is the commonest fracture, mainly in
      elder females with osteoporosis and also obesity. Normally 75% of patients are treated with
      plaster after fracture repositioning. The remaining 25% are operated upon. Routinely, the
      operation is performed under neuroaxial blockade and sedation. When the blockade rapidly
      vanish many patients experience a rebound pain much severer than the initial trauma pain. If
      long acting local anesthetics are used the blockade will be terminated during night and many
      patients will go to the Emergency room for pain treatment. Short acting local anesthetics may
      make it possible to treat patients pain in-house prior to hospital discharge and thus reduce
      severe rebound pain.

      In this study patients with radial fractures are included and operated upon by a standard
      surgical operation with plate and screws. They will receive either 1) ultra sound guided
      supraclavicular block long-acting (n=30) local anesthetic , 2) ultra sound guided
      supraclavicular block short-acing (n=60) local anesthetics or 3) general anesthesia (n=30) to
      provide analgesia during the operational procedure. Patients given an ultra sound guided
      blockade with short-acting local anesthetic (n=60) are further sub-divided into receiving
      either postoperative plaster/cast (n=30) or an orthosis/brace (n=30).

      Patients pain will be measured by Numeric Rating scale (0 = no pain and 10 worst possible
      pain) during the first 7 postoperative days. The opioid consumption will be noted by personal
      contact intermittently by telephone and by a pain diary until day 7. Both parametric and
      none-parametric analysis will be conducted.

      Quality of recovery will be assessed by Quality of Recovery Scale 15 at 5 occasions. Adverse
      effects and unplanned health care contacts will also be gathered.

      After 3 days the Occupational Therapist will control the patients followed by investigations
      at 2, 6 12 and 52 weeks. The patients will be graded the Patient rated Wrist Evaluation
      (PRWE) and Michigan Outcomes Questionnaire (MHQ) Edema will be measured and strength will be
      measured by Jamar dynamometer, Finally, Sense of coherence will be measured by KASAM-13
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: Patients are subdivided into 3 groups where one group is further subdivided into 2 groups
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Rebound pain, difference in pain (NRS) at rest at 24-hours and further during the first three days after surgery between short acting block (mepivacaine) and long acting block (ropivacaine), with General Anesthesia being control group.
time frame: 72 hours
description: Postoperative pain measured by numeric pain rating scale (NRS), where 0 = no pain and 10 = worst possible pain.
measure: Quality of Recovery; difference in sum median and its five domains of QoR-15 score at baseline, 24 hours, 72 hours and 7 days after surgery between the two groups cast and orthosis/brace. - Anesthesiology part 2
time frame: 1st three postoperative days
description: Quality of Recovery scale 15 assessment
measure: Post surgery arm function - Occupational therapist
time frame: 12 months
description: Influence of immobilization by plaster or orthosis/brace
measure: Post surgery opioid requirement - Anesthesiology part
time frame: day 1 to 3 after surgery, including day 7 assessing immobilization (cast/brace)
description: daily opioid requirement mg dose
measure: Perioperative time events - Anesthesiology part
time frame: perioperatively
description: Perioperative time events; e.g. duration of surgery, anesthesia, Theatre time and recovery room stay
measure: Postoperative Nausea and Vomiting - Anesthesiology part
time frame: up to 72 hours post surgery
description: Any experience of PONV
measure: Unplanned health care contact - Anesthesiology part
time frame: 1st postoperative week
description: any unplanned contact with health care, emergency department visit, phone calls, GP visits etc.
measure: Post surgery arm status 1 - Occupational therapist
time frame: 12 months
description: Clinical evaluation of post surgery arm status by a physiotherapist including: oedema,
measure: Post surgery arm status 2 - Occupational therapist
time frame: 12 months
description: Clinical evaluation of post surgery arm status by a physiotherapist including: grip strength
measure: Post surgery arm status 3 - Occupational therapist
time frame: 12 months
description: Clinical evaluation of post surgery arm status by a physiotherapist including sense of coherence.
arm group label: Long acting anesthetic block/plaster
arm group type: Active Comparator
description: Intervention 1: Blockade will be given supraclavicularly with Long acting local Anesthetic (n=30) combined with post operative plaster immobilization.
arm group label: Short acting anesthetic block/plaster
arm group type: Active Comparator
description: Intervention 2: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) combined with plaster immobilisation postoperatively
arm group label: Short acting anesthetic block/orthotic
arm group type: Active Comparator
description: Intervention 3: Blockade will be given supraclavicularly with Short acting local anesthetic (n=30) and combined with orthosis for postoperative immobilisation
arm group label: General Anesthesia and plaster
arm group type: Active Comparator
description: Intervention 4: General anesthesia wil be administered for surgical procedure combined with postoperative plaster immobilisation (n=30),
intervention type: Procedure
intervention name: Long acting Supraclivicular block vs Short acting Supraclavicular block
description: Patients are randomized to receive; long-acting Supraclavicular plexus block or short-acting Supraclavicular plexus block or general anesthesia
Sub group randomized to plaster/cast or orthosis/brace, both having short-acting block
arm group label: General Anesthesia and plaster
arm group label: Long acting anesthetic block/plaster
arm group label: Short acting anesthetic block/orthotic
arm group label: Short acting anesthetic block/plaster
other name: Long acting anesthetic block/plaster
other name: Short acting anesthetic block/plaster
other name: Short acting anesthetic block/orthosis
other name: General Anesthesia and plaster
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bengt Nellgard, MD PhD
role: Principal Investigator
affiliation: Göteborg University
facility: 
country: Sweden
citation: Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.
PMID: 26869374
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Bengt Nellgård
investigator title: Associate professor
mesh term: Fractures, Bone
mesh term: Radius Fractures
mesh term: Anesthetics
sharing ipd: No