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/NCT06009302</url>
    </required_header>
    <id_info>
      <org_study_id>12071987</org_study_id>
      <nct_id>NCT06009302</nct_id>
    </id_info>
    <brief_title>Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars</brief_title>
    <official_title>Analgesic Effects of Extraoral Ultrasound Block of Mandibular Nerve for the Extraction of Lower Third Molars</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Varazdin General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Clinical Hospital Centre Zagreb</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Varazdin General Hospital</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>
        This is a study about the dynamics and effects of different types of blocks (intraoral&#xD;
        conduction anesthesia of the alveolar nerve and extraoral US block of the mandibular nerve)&#xD;
        for extraction of lower third molars.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Standard method of anesthesia for extraction of horizontally positioned lower thirdmolars is&#xD;
        intraoral conduction anesthesia of the inferior alveolar nerve. However, the analgesiceffect&#xD;
        of block is short and it is necessary to use analgesics. In this prospective clinical&#xD;
        study,analgesic effect of ultrasound (US) -guided extraoral block of mandibular nerve will&#xD;
        beinvestigated, in order to prolong pain-free time and reduce the use of analgesics&#xD;
        associated withrisks (bleeding, hepatotoxicity).&#xD;
  &#xD;
        Characteristics of alveolar nerve block and US block of the mandibular nerve will becompared,&#xD;
        such as: pain during application of anesthesia, amount of anesthetic, duration ofanesthesia,&#xD;
        need to use analgesics, time to and level of pain when using analgesics, andcomplications&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time without pain</measure>
      <time_frame>first 24 postoperative hours</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time of numbness</measure>
      <time_frame>first 24 postoperative hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain level when anesthesia is applied</measure>
      <time_frame>first 24 postoperative hours</time_frame>
      <description>0-10 on VAS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain level when painkiller is needed</measure>
      <time_frame>first 24 postoperative hours</time_frame>
      <description>0-10 on VAS</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Molar</condition>
    <condition>Impacted Teeth</condition>
    <arm_group>
      <arm_group_label>US block of mandibular nerve</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Extraoral ultrasound-guided block of the mandibular nerve will be performed iusing an ultrasound device. After visualisation of the pterygomandibular space, of the maxillary artery and the mandibular nerve next to it, at a depth of 2-4 cm, the detection of the maxillary artery is confirmed by Color Doppler. A needle enters between the coronoid and condylar processes, using the &quot;out of plane&quot; technique, near the maxillary artery, and after negative aspiration, local anesthetic ropivacaine (0.75%, 2.5 mL) will be applied.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>intraoral block of lower alveolar nerve</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>During the intraoral block of the inferior alveolar nerve, the patient will lie with his mouth wide open, and the inferior alveolar, lingual and buccal nerves will be anesthetized using two injections. The anesthetic used will be 40 mg/mL articaine chloride+0.01 mg/mL epinephrine: the planned amount of anesthetic is 2×1.7 mL, and if anesthesia is not achieved, an additional volume of anesthetic will be added as needed, until anesthesia</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>US guided block of mandibular nerve</intervention_name>
      <description>Extraoral ultrasound-guided block of the mandibular nerve will be performed in the examined group using an ultrasound device, using ropivacaine (0.75%, 2.5 mL).</description>
      <arm_group_label>US block of mandibular nerve</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intraoral block of lower alveolar nerve</intervention_name>
      <description>Block of lower alveolar nerve will be applied intraoraly using articaine+adrenaline</description>
      <arm_group_label>intraoral block of lower alveolar nerve</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18-64 years&#xD;
  &#xD;
            -  horizontally placed lower third molars&#xD;
  &#xD;
            -  ASA I or II group&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  allergy to local anesthetics&#xD;
  &#xD;
            -  local infection at the site of needle puncture&#xD;
  &#xD;
            -  parotitis&#xD;
  &#xD;
            -  serious liver disease&#xD;
  &#xD;
            -  use of antiarrhythmics group III (eg amiodarone), anticoagulant or antithrombotic&#xD;
               drugs&#xD;
  &#xD;
            -  lactation&#xD;
  &#xD;
            -  people who took an analgesic as a preventive measure before coming to the procedure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Varazdin General Hospital</name>
        <address>
          <city>Varaždin</city>
          <zip>42000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marija Martinus, MD</last_name>
        <phone>+385 99 682 7489</phone>
        <email>marija.martinus@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Marija Martinus</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Croatia</country>
    </location_countries>
    <link>
      <url>https://halmed.hr/upl/lijekovi/PIL/Arthryl-1500-mg-prasak-za-oralnu-otopinu-PIL.pdf</url>
      <description>Side effect of glucosaimine to coagulation</description>
    </link>
    <link>
      <url>http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0121-246X2019000100166</url>
      <description>The use of analgesics and anti-inflammatories in an oral surgery service in Medellín, Colombia, 2013-2015</description>
    </link>
    <reference>
      <citation>Khorshidi Khiavi R, Pourallahverdi M, Pourallahverdi A, Ghorani Khiavi S, Ghertasi Oskouei S, Mokhtari H. Pain control following impacted third molar surgery with bupivacaine irrigation of tooth socket: a prospective study. J Dent Res Dent Clin Dent Prospects. 2010 Fall;4(4):105-9. doi: 10.5681/joddd.2010.027. Epub 2010 Dec 21.</citation>
      <PMID>23346335</PMID>
    </reference>
    <reference>
      <citation>Fisher SE, Frame JW, Rout PG, McEntegart DJ. Factors affecting the onset and severity of pain following the surgical removal of unilateral impacted mandibular third molar teeth. Br Dent J. 1988 Jun 11;164(11):351-4. doi: 10.1038/sj.bdj.4806453. No abstract available.</citation>
      <PMID>3165011</PMID>
    </reference>
    <reference>
      <citation>Teoh L, Moses G, McCullough MJ. A review of drugs that contribute to bleeding risk in general dental practice. Aust Dent J. 2020 Jun;65(2):118-130. doi: 10.1111/adj.12751. Epub 2020 Mar 13.</citation>
      <PMID>32064612</PMID>
    </reference>
    <reference>
      <citation>Plantevin F, Pascal J, Morel J, Roussier M, Charier D, Prades JM, Auboyer C, Molliex S. Effect of mandibular nerve block on postoperative analgesia in patients undergoing oropharyngeal carcinoma surgery under general anaesthesia. Br J Anaesth. 2007 Nov;99(5):708-12. doi: 10.1093/bja/aem242. Epub 2007 Sep 19.</citation>
      <PMID>17884802</PMID>
    </reference>
    <reference>
      <citation>Kumar A, Sinha C, Kumar A, Kumari P, Mukul SK. Ultrasound-guided trigeminal nerve block and its comparison with conventional analgesics in patients undergoing faciomaxillary surgery: Randomised control trial. Indian J Anaesth. 2018 Nov;62(11):871-875. doi: 10.4103/ija.IJA_256_18.</citation>
      <PMID>30532323</PMID>
    </reference>
    <reference>
      <citation>Stojanovic S, Buric N, Tijanic M, Todorovic K, Buric K, Buric N, Jovanovic M, Bajagic V. The Assessment of Prolonged Inferior Alveolar Nerve Blockade for Postoperative Analgesia in Mandibular Third Molar Surgery by a Perineural Addition of Dexamethasone to 0.5% Ropivacaine: A Randomized Comparison Study. Int J Environ Res Public Health. 2022 Jan 25;19(3):1324. doi: 10.3390/ijerph19031324.</citation>
      <PMID>35162346</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dental anesthesia</keyword>
    <keyword>inferior alveolar nerve</keyword>
    <keyword>regional anesthesia</keyword>
    <keyword>ultrasound</keyword>
    <keyword>mandibular nerve</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tooth, Impacted</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/NCT06009302
  org study id: 12071987
  nct id: NCT06009302
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a study about the dynamics and effects of different types of blocks (intraoral
        conduction anesthesia of the alveolar nerve and extraoral US block of the mandibular nerve)
        for extraction of lower third molars.
  Standard method of anesthesia for extraction of horizontally positioned lower thirdmolars is
        intraoral conduction anesthesia of the inferior alveolar nerve. However, the analgesiceffect
        of block is short and it is necessary to use analgesics. In this prospective clinical
        study,analgesic effect of ultrasound (US) -guided extraoral block of mandibular nerve will
        beinvestigated, in order to prolong pain-free time and reduce the use of analgesics
        associated withrisks (bleeding, hepatotoxicity).
  
        Characteristics of alveolar nerve block and US block of the mandibular nerve will becompared,
        such as: pain during application of anesthesia, amount of anesthetic, duration ofanesthesia,
        need to use analgesics, time to and level of pain when using analgesics, andcomplications
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Time without pain
  time frame: first 24 postoperative hours
  measure: Time of numbness
  time frame: first 24 postoperative hours
  measure: Pain level when anesthesia is applied
  time frame: first 24 postoperative hours
  description: 0-10 on VAS
  measure: Pain level when painkiller is needed
  time frame: first 24 postoperative hours
  description: 0-10 on VAS
  arm group label: US block of mandibular nerve
  arm group type: Experimental
  description: Extraoral ultrasound-guided block of the mandibular nerve will be performed iusing an ultrasound device. After visualisation of the pterygomandibular space, of the maxillary artery and the mandibular nerve next to it, at a depth of 2-4 cm, the detection of the maxillary artery is confirmed by Color Doppler. A needle enters between the coronoid and condylar processes, using the "out of plane" technique, near the maxillary artery, and after negative aspiration, local anesthetic ropivacaine (0.75%, 2.5 mL) will be applied.
  arm group label: intraoral block of lower alveolar nerve
  arm group type: Active Comparator
  description: During the intraoral block of the inferior alveolar nerve, the patient will lie with his mouth wide open, and the inferior alveolar, lingual and buccal nerves will be anesthetized using two injections. The anesthetic used will be 40 mg/mL articaine chloride+0.01 mg/mL epinephrine: the planned amount of anesthetic is 2×1.7 mL, and if anesthesia is not achieved, an additional volume of anesthetic will be added as needed, until anesthesia
  intervention type: Procedure
  intervention name: US guided block of mandibular nerve
  description: Extraoral ultrasound-guided block of the mandibular nerve will be performed in the examined group using an ultrasound device, using ropivacaine (0.75%, 2.5 mL).
  arm group label: US block of mandibular nerve
  intervention type: Procedure
  intervention name: Intraoral block of lower alveolar nerve
  description: Block of lower alveolar nerve will be applied intraoraly using articaine+adrenaline
  arm group label: intraoral block of lower alveolar nerve
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Croatia
  url: https://halmed.hr/upl/lijekovi/PIL/Arthryl-1500-mg-prasak-za-oralnu-otopinu-PIL.pdf
  description: Side effect of glucosaimine to coagulation
  url: http://www.scielo.org.co/scielo.php?script=sci_arttext&pid=S0121-246X2019000100166
  description: The use of analgesics and anti-inflammatories in an oral surgery service in Medellín, Colombia, 2013-2015
  citation: Khorshidi Khiavi R, Pourallahverdi M, Pourallahverdi A, Ghorani Khiavi S, Ghertasi Oskouei S, Mokhtari H. Pain control following impacted third molar surgery with bupivacaine irrigation of tooth socket: a prospective study. J Dent Res Dent Clin Dent Prospects. 2010 Fall;4(4):105-9. doi: 10.5681/joddd.2010.027. Epub 2010 Dec 21.
  PMID: 23346335
  citation: Fisher SE, Frame JW, Rout PG, McEntegart DJ. Factors affecting the onset and severity of pain following the surgical removal of unilateral impacted mandibular third molar teeth. Br Dent J. 1988 Jun 11;164(11):351-4. doi: 10.1038/sj.bdj.4806453. No abstract available.
  PMID: 3165011
  citation: Teoh L, Moses G, McCullough MJ. A review of drugs that contribute to bleeding risk in general dental practice. Aust Dent J. 2020 Jun;65(2):118-130. doi: 10.1111/adj.12751. Epub 2020 Mar 13.
  PMID: 32064612
  citation: Plantevin F, Pascal J, Morel J, Roussier M, Charier D, Prades JM, Auboyer C, Molliex S. Effect of mandibular nerve block on postoperative analgesia in patients undergoing oropharyngeal carcinoma surgery under general anaesthesia. Br J Anaesth. 2007 Nov;99(5):708-12. doi: 10.1093/bja/aem242. Epub 2007 Sep 19.
  PMID: 17884802
  citation: Kumar A, Sinha C, Kumar A, Kumari P, Mukul SK. Ultrasound-guided trigeminal nerve block and its comparison with conventional analgesics in patients undergoing faciomaxillary surgery: Randomised control trial. Indian J Anaesth. 2018 Nov;62(11):871-875. doi: 10.4103/ija.IJA_256_18.
  PMID: 30532323
  citation: Stojanovic S, Buric N, Tijanic M, Todorovic K, Buric K, Buric N, Jovanovic M, Bajagic V. The Assessment of Prolonged Inferior Alveolar Nerve Blockade for Postoperative Analgesia in Mandibular Third Molar Surgery by a Perineural Addition of Dexamethasone to 0.5% Ropivacaine: A Randomized Comparison Study. Int J Environ Res Public Health. 2022 Jan 25;19(3):1324. doi: 10.3390/ijerph19031324.
  PMID: 35162346
  responsible party type: Sponsor
  mesh term: Tooth, Impacted
  sharing ipd: No