<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/NCT03277599</url>
  </required_header>
  <id_info>
    <org_study_id>2011-KAEK-25 2016/21-02</org_study_id>
    <nct_id>NCT03277599</nct_id>
  </id_info>
  <brief_title>Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain</brief_title>
  <official_title>Ultrasound Guided Superficial Cervical Plexus Block Versus Greater Auricular Nerve Block for Tympanomastoid Surgery Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bursa Yüksek İhtisas Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bursa Yüksek İhtisas Education and Research Hospital</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>
      Analgesia following tympanomastoid surgery is critical for the prevention of postoperative .&#xD;
      There are very few regional anesthesia methods used to achieve this goal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, it was aimed to investigate the effect of Ultrasound guided superficial&#xD;
      cervical plexus block versus greater auricular nerve block for on postoperative&#xD;
      tympanomastoid surgery analgesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2016</start_date>
  <completion_date type="Actual">July 7, 2017</completion_date>
  <primary_completion_date type="Actual">December 5, 2016</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>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective,randomized,single blind</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Pain Scale</measure>
    <time_frame>Postoperative 24 hours</time_frame>
    <description>Visual Analog Pain Scale was used for pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tramadol consumption</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>tramadol consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effect profile</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>additional analgesic use</measure>
    <time_frame>Postoperative 24 hour</time_frame>
    <description>additional analgesic use</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pain Management</condition>
  <condition>Nerve Block</condition>
  <condition>Ultrasound</condition>
  <arm_group>
    <arm_group_label>Grup Y</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine+IV patient-controlled analgesia (PCA) tramadol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Grup B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ultrasound ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV patient-controlled analgesia (PCA) tramadol</intervention_name>
    <description>Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.</description>
    <arm_group_label>Grup B</arm_group_label>
    <arm_group_label>Grup Y</arm_group_label>
    <other_name>Tramadol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ultrasound guided superficial cervical plexus block</intervention_name>
    <description>ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine</description>
    <arm_group_label>Grup Y</arm_group_label>
    <other_name>superficial cervical plexus block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ultrasound guided Great Auricular nerve block</intervention_name>
    <description>ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol</description>
    <arm_group_label>Grup B</arm_group_label>
    <other_name>Great Auricular nerve block</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who were in the American Society of Anesthesiologists (ASA) I-III class and&#xD;
             underwent Tympanomastoid surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of opioid use preoperatively,&#xD;
&#xD;
          -  Allergy to local anesthetics,&#xD;
&#xD;
          -  The presence of any systemic infection,&#xD;
&#xD;
          -  Uncontrolled arterial hypertension,&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Korgün Ökmen, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospita</affiliation>
  </overall_official>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>March 19, 2018</last_update_submitted>
  <last_update_submitted_qc>March 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bursa Yüksek İhtisas Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Korgün Ökmen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03277599
org study id: 2011-KAEK-25 2016/21-02
nct id: NCT03277599
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Analgesia following tympanomastoid surgery is critical for the prevention of postoperative .
      There are very few regional anesthesia methods used to achieve this goal.
In this study, it was aimed to investigate the effect of Ultrasound guided superficial
      cervical plexus block versus greater auricular nerve block for on postoperative
      tympanomastoid surgery analgesia.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective,randomized,single blind
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Visual Analog Pain Scale
time frame: Postoperative 24 hours
description: Visual Analog Pain Scale was used for pain
measure: tramadol consumption
time frame: Postoperative 24 hour
description: tramadol consumption
measure: side effect profile
time frame: Postoperative 24 hour
description: side effect profile (including nausea and vomiting, hypotension,requirement and the Ramsay Sedation Scale (RSS) scores)
measure: additional analgesic use
time frame: Postoperative 24 hour
description: additional analgesic use
arm group label: Grup Y
arm group type: Active Comparator
description: ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine+IV patient-controlled analgesia (PCA) tramadol
arm group label: Grup B
arm group type: Active Comparator
description: ultrasound ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol
intervention type: Drug
intervention name: IV patient-controlled analgesia (PCA) tramadol
description: Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
arm group label: Grup B
arm group label: Grup Y
other name: Tramadol
intervention type: Drug
intervention name: ultrasound guided superficial cervical plexus block
description: ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine
arm group label: Grup Y
other name: superficial cervical plexus block
intervention type: Drug
intervention name: ultrasound guided Great Auricular nerve block
description: ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol
arm group label: Grup B
other name: Great Auricular nerve block
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Korgün Ökmen, M.D
role: Principal Investigator
affiliation: University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospita
responsible party type: Principal Investigator
investigator affiliation: Bursa Yüksek İhtisas Education and Research Hospital
investigator full name: Korgün Ökmen
investigator title: Principal Investigator
mesh term: Tramadol