xml: <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/NCT05996315</url>
    </required_header>
    <id_info>
      <org_study_id>40/22/IEC/JMMC&amp;RI</org_study_id>
      <nct_id>NCT05996315</nct_id>
    </id_info>
    <brief_title>Ultrasound Guided Supracondylar Nerve Block &amp; Hematoma Block for Closed Reduction of Distal End Radius Fractures</brief_title>
    <official_title>Ultrasound Guided Supracondylar Nerve Block &amp; Hematoma Block for Closed Reduction of Distal End Radius Fractures - an Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jubilee Mission Medical College and Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jubilee Mission Medical College and Research Institute</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Comparison of analgesia between ultrasound guided supracondylar radial nerve block and&#xD;
        hematoma block for closed reduction of distal end radius fractures- an observational study&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A patient who presents to the emergency department with a suspected distal end radius&#xD;
        fracture will be assessed with a baseline NRS score1 and given analgesics if needed. Further&#xD;
        they will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to&#xD;
        give hematoma block or supracondylar radial nerve block will be taken as per the choice of&#xD;
        the treating physician. Patients who do not meet the exclusion criteria are excluded from the&#xD;
        study at this phase. NRS score 2 is assessed once again prior to block and a Hematoma block/&#xD;
        Supracondylar radial nerve block is given. Needle in and out time will be noted and the pain&#xD;
        during needling is evaluated using the NRS score 3. Pain score will further be evaluated for&#xD;
        every 10 mins after needle out time for a maximum of 30 mins or when the patient gets&#xD;
        adequate analgesia ( NRS score 4a, 4b, 4c, 4d).&#xD;
  &#xD;
        If the block is successful, the treating physician will proceed to fracture reduction. If the&#xD;
        block is a failure the physician will go for a rescue analgesia. NRS score5 will be evaluated&#xD;
        at this stage. Further a NRS score 6 will be assessed 15 minutes post reduction. An x-ray&#xD;
        will be checked for the evaluation of the reduction procedure performed and the patient will&#xD;
        be discharged or admitted as necessary. The patient will be further followed after 1 week for&#xD;
        delayed complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 15, 2022</start_date>
    <completion_date type="Anticipated">February 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 15, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To compare analgesic effect of supracondylar radial nerve block with hematoma block under ultrasound guidance in closed reduction of distal end radius fractures in emergency department assessed using numerical rating scale.</measure>
      <time_frame>60 minute</time_frame>
      <description>To compare analgesic effect of supracondylar radial nerve block with hematoma block under ultrasound guidance in closed reduction of distal end radius fractures in emergency department assessed using numerical rating scale during before closed reduction, during reduction &amp; after closed reduction.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To compare time taken for performing hematoma block &amp; supracondylar radial nerve block</measure>
      <time_frame>60minute</time_frame>
      <description>To compare the time taken for hematoma block &amp; supracondylar radial nerve block for closed reduction of distal end radius fracture. Time is noted from needle in to needle out for both technique.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare time taken for analgesic effect of hematoma block &amp; supracondylar radial nerve block for closed reduction of distal end radius fracture</measure>
      <time_frame>60minute</time_frame>
      <description>compare the analgesic effects of both technique ,which reduces the pain score more during the closed reduction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To compare complication rates of hematoma block &amp; supracondylar radial nerve block for closed reduction of distal end radius fracture</measure>
      <time_frame>18months</time_frame>
      <description>Compare the immediate &amp; delayed complications upto 7 days after the procedure</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Adults &gt;18 Years With Distal End Radius Fracture Requiring Closed Reduction in Emergency Department</condition>
    <arm_group>
      <arm_group_label>Adults &gt;18 years with distal end radius fracture</arm_group_label>
      <description>Adults &gt; 18 years with distal end radius fracture requiring closed reduction in Emergency Department</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hematoma block</intervention_name>
      <description>A patient who presents to the emergency department with a suspected distal end radius fracture , will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to give hematoma block will be taken as per the choice of the treating physician. Patients who do not meet the exclusion criteria are excluded from the study at this phase.</description>
      <arm_group_label>Adults &gt;18 years with distal end radius fracture</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Supracondylar radial nerve block</intervention_name>
      <description>A patient who presents to the emergency department with a suspected distal end radius fracture will be assessed with a baseline NRS score1 and given analgesics if needed. Further they will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to give supracondylar radial nerve block will be taken as per the choice of the treating physician. Patients who do not meet the exclusion criteria are excluded from the study at this phase.</description>
      <arm_group_label>Adults &gt;18 years with distal end radius fracture</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient who present with isolated distal end radius fracture.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults &gt; 18 years with distal end radius fracture requiring closed reduction in&#xD;
               Emergency Department&#xD;
  &#xD;
            2. Patient who legally consent for study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of allergy to local anesthetics&#xD;
  &#xD;
            2. Pregnant or lactating women&#xD;
  &#xD;
            3. Infection or burn with local anaesthetic at injection site&#xD;
  &#xD;
            4. Patients having other fractures or significant injuries that are causing pain&#xD;
  &#xD;
            5. Patients with hemodynamic instability which includes patients with GCS score less than&#xD;
               15 under influence of alcohol/ inebriated state.&#xD;
  &#xD;
            6. Patients on anticoagulants&#xD;
  &#xD;
            7. Patients with compromised neurovascular system&#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_contact>
      <last_name>ROSHAN BENNY, MBBS</last_name>
      <phone>+918281105815</phone>
      <email>roshanbenny@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Emergency Medicine Department of Jubilee Mission Medical College &amp; Research Institute, Thrissur</name>
        <address>
          <city>Thrissur</city>
          <state>Kerala</state>
          <zip>680 005</zip>
          <country>India</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Roshan Benny</last_name>
        <phone>+918281105815</phone>
        <email>roshanbenny@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <link>
      <url>https://emj.bmj.com/content/32/6/474</url>
      <description>Ultrasound guided haematoma block may be a safe and effective alternative to procedural sedation and analgesia.</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/27342965/</url>
      <description>ultrasound guided radial nerve block is safe</description>
    </link>
    <reference>
      <citation>Maleitzke T, Plachel F, Fleckenstein FN, Wichlas F, Tsitsilonis S. Haematoma block: a safe method for pre-surgical reduction of distal radius fractures. J Orthop Surg Res. 2020 Aug 26;15(1):351. doi: 10.1186/s13018-020-01819-y.</citation>
      <PMID>32843043</PMID>
    </reference>
    <reference>
      <citation>Unluer EE, Karagoz A, Unluer S, Kosargelir M, Kizilkaya M, Alimoglu O, Akoglu H, Aslan C. Ultrasound-guided supracondylar radial nerve block for Colles Fractures in the ED. Am J Emerg Med. 2016 Aug;34(8):1718-20. doi: 10.1016/j.ajem.2016.06.007. Epub 2016 Jun 8. No abstract available.</citation>
      <PMID>27342965</PMID>
    </reference>
    <reference>
      <citation>Tabrizi A, Mirza Tolouei F, Hassani E, Taleb H, Elmi A. Hematoma Block Versus General Anesthesia in Distal Radius Fractures in Patients Over 60 Years in Trauma Emergency. Anesth Pain Med. 2016 Nov 27;7(1):e40619. doi: 10.5812/aapm.40619. eCollection 2017 Feb.</citation>
      <PMID>28920036</PMID>
    </reference>
    <reference>
      <citation>Fathi M, Moezzi M, Abbasi S, Farsi D, Zare MA, Hafezimoghadam P. Ultrasound-guided hematoma block in distal radial fracture reduction: a randomised clinical trial. Emerg Med J. 2015 Jun;32(6):474-7. doi: 10.1136/emermed-2013-202485. Epub 2014 Jul 12.</citation>
      <PMID>25016389</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jubilee Mission Medical College and Research Institute</investigator_affiliation>
      <investigator_full_name>Dr Roshan Benny</investigator_full_name>
      <investigator_title>Junior Resident</investigator_title>
    </responsible_party>
    <keyword>distal end radius fracture</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Hematoma</mesh_term>
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Radius Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996315
  org study id: 40/22/IEC/JMMC&RI
  nct id: NCT05996315
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Comparison of analgesia between ultrasound guided supracondylar radial nerve block and
        hematoma block for closed reduction of distal end radius fractures- an observational study
  A patient who presents to the emergency department with a suspected distal end radius
        fracture will be assessed with a baseline NRS score1 and given analgesics if needed. Further
        they will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to
        give hematoma block or supracondylar radial nerve block will be taken as per the choice of
        the treating physician. Patients who do not meet the exclusion criteria are excluded from the
        study at this phase. NRS score 2 is assessed once again prior to block and a Hematoma block/
        Supracondylar radial nerve block is given. Needle in and out time will be noted and the pain
        during needling is evaluated using the NRS score 3. Pain score will further be evaluated for
        every 10 mins after needle out time for a maximum of 30 mins or when the patient gets
        adequate analgesia ( NRS score 4a, 4b, 4c, 4d).
  
        If the block is successful, the treating physician will proceed to fracture reduction. If the
        block is a failure the physician will go for a rescue analgesia. NRS score5 will be evaluated
        at this stage. Further a NRS score 6 will be assessed 15 minutes post reduction. An x-ray
        will be checked for the evaluation of the reduction procedure performed and the patient will
        be discharged or admitted as necessary. The patient will be further followed after 1 week for
        delayed complications.
  observational model: Cohort
  time perspective: Prospective
  measure: To compare analgesic effect of supracondylar radial nerve block with hematoma block under ultrasound guidance in closed reduction of distal end radius fractures in emergency department assessed using numerical rating scale.
  time frame: 60 minute
  description: To compare analgesic effect of supracondylar radial nerve block with hematoma block under ultrasound guidance in closed reduction of distal end radius fractures in emergency department assessed using numerical rating scale during before closed reduction, during reduction & after closed reduction.
  measure: To compare time taken for performing hematoma block & supracondylar radial nerve block
  time frame: 60minute
  description: To compare the time taken for hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture. Time is noted from needle in to needle out for both technique.
  measure: To compare time taken for analgesic effect of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture
  time frame: 60minute
  description: compare the analgesic effects of both technique ,which reduces the pain score more during the closed reduction
  measure: To compare complication rates of hematoma block & supracondylar radial nerve block for closed reduction of distal end radius fracture
  time frame: 18months
  description: Compare the immediate & delayed complications upto 7 days after the procedure
  arm group label: Adults >18 years with distal end radius fracture
  description: Adults > 18 years with distal end radius fracture requiring closed reduction in Emergency Department
  intervention type: Other
  intervention name: Hematoma block
  description: A patient who presents to the emergency department with a suspected distal end radius fracture , will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to give hematoma block will be taken as per the choice of the treating physician. Patients who do not meet the exclusion criteria are excluded from the study at this phase.
  arm group label: Adults >18 years with distal end radius fracture
  intervention type: Other
  intervention name: Supracondylar radial nerve block
  description: A patient who presents to the emergency department with a suspected distal end radius fracture will be assessed with a baseline NRS score1 and given analgesics if needed. Further they will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to give supracondylar radial nerve block will be taken as per the choice of the treating physician. Patients who do not meet the exclusion criteria are excluded from the study at this phase.
  arm group label: Adults >18 years with distal end radius fracture
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: ROSHAN BENNY, MBBS
  phone: +918281105815
  email: roshanbenny@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: India
  url: https://emj.bmj.com/content/32/6/474
  description: Ultrasound guided haematoma block may be a safe and effective alternative to procedural sedation and analgesia.
  url: https://pubmed.ncbi.nlm.nih.gov/27342965/
  description: ultrasound guided radial nerve block is safe
  citation: Maleitzke T, Plachel F, Fleckenstein FN, Wichlas F, Tsitsilonis S. Haematoma block: a safe method for pre-surgical reduction of distal radius fractures. J Orthop Surg Res. 2020 Aug 26;15(1):351. doi: 10.1186/s13018-020-01819-y.
  PMID: 32843043
  citation: Unluer EE, Karagoz A, Unluer S, Kosargelir M, Kizilkaya M, Alimoglu O, Akoglu H, Aslan C. Ultrasound-guided supracondylar radial nerve block for Colles Fractures in the ED. Am J Emerg Med. 2016 Aug;34(8):1718-20. doi: 10.1016/j.ajem.2016.06.007. Epub 2016 Jun 8. No abstract available.
  PMID: 27342965
  citation: Tabrizi A, Mirza Tolouei F, Hassani E, Taleb H, Elmi A. Hematoma Block Versus General Anesthesia in Distal Radius Fractures in Patients Over 60 Years in Trauma Emergency. Anesth Pain Med. 2016 Nov 27;7(1):e40619. doi: 10.5812/aapm.40619. eCollection 2017 Feb.
  PMID: 28920036
  citation: Fathi M, Moezzi M, Abbasi S, Farsi D, Zare MA, Hafezimoghadam P. Ultrasound-guided hematoma block in distal radial fracture reduction: a randomised clinical trial. Emerg Med J. 2015 Jun;32(6):474-7. doi: 10.1136/emermed-2013-202485. Epub 2014 Jul 12.
  PMID: 25016389
  responsible party type: Principal Investigator
  investigator affiliation: Jubilee Mission Medical College and Research Institute
  investigator full name: Dr Roshan Benny
  investigator title: Junior Resident
  mesh term: Emergencies
  mesh term: Hematoma
  mesh term: Fractures, Bone
  mesh term: Radius Fractures
  sharing ipd: No