<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/NCT03806335</url>
  </required_header>
  <id_info>
    <org_study_id>32015</org_study_id>
    <nct_id>NCT03806335</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Local Infiltration Technique in Adult Tonsillectomy</brief_title>
  <official_title>The Effect of Local Infiltration Technique on Postoperative Pain After Adult Tonsillectomy: A Randomized Double-blind Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General 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>
      Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision&#xD;
      infiltration of anesthetic mixture combined with general anesthesia was shown to decrease&#xD;
      post-tonsillectomy pain in children. Hence, the present clinical trial will assess the&#xD;
      effectiveness of this technique in adults undergoing tonsillectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted prospectively, using a randomized double-blind design. Adult&#xD;
      patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting&#xD;
      from January 2019 till January 2020 will be included.Patients will be allocated randomly into&#xD;
      two equal groups using the sealed envelope method. Both groups will receive general&#xD;
      anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia&#xD;
      mixture in each tonsil. The second group will have placebo infiltration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Lack of patients&#xD;
  </why_stopped>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post operative pain</measure>
    <time_frame>within 10 days after the operation</time_frame>
    <description>Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PONV</measure>
    <time_frame>within 10 days after the operation</time_frame>
    <description>Post operative nausea and vomiting (PONV) will be assessed through a questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Post Operative Pain</condition>
  <arm_group>
    <arm_group_label>Infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infiltration</intervention_name>
    <description>The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%</description>
    <arm_group_label>Infiltration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Patients will receive 2.5 ml normal saline in each tonsil</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>General anesthesia</intervention_name>
    <description>All patients will receive general anesthesia prior to infiltration</description>
    <arm_group_label>Infiltration</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with total or partial tonsillectomy with or without adenoidectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who took antiemetics, steroids, or antihistaminics within 24 hours before&#xD;
             surgery. - patients who have asthma&#xD;
&#xD;
          -  patients who have diabetes&#xD;
&#xD;
          -  patients who have bleeding problems&#xD;
&#xD;
          -  patients who are suspected to have signs of acute pharyngeal infection&#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>Zoher Naja</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makassed General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Zoher Naja</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT03806335
org study id: 32015
nct id: NCT03806335
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Tonsillectomy is commonly associated with postoperative pain. The modified pre-incision
      infiltration of anesthetic mixture combined with general anesthesia was shown to decrease
      post-tonsillectomy pain in children. Hence, the present clinical trial will assess the
      effectiveness of this technique in adults undergoing tonsillectomy.
The study will be conducted prospectively, using a randomized double-blind design. Adult
      patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting
      from January 2019 till January 2020 will be included.Patients will be allocated randomly into
      two equal groups using the sealed envelope method. Both groups will receive general
      anesthesia. Then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia
      mixture in each tonsil. The second group will have placebo infiltration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Post operative pain
time frame: within 10 days after the operation
description: Pain after the operation will be assessed using the Visual Analogue Scale (VAS). A minimum VAS score is 0 and the maximum score is 10.
measure: PONV
time frame: within 10 days after the operation
description: Post operative nausea and vomiting (PONV) will be assessed through a questionnaire
arm group label: Infiltration
arm group type: Experimental
description: Patients will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will receive pre-incision infiltration of 2.5 ml saline in each tonsil.
intervention type: Other
intervention name: Infiltration
description: The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%
arm group label: Infiltration
intervention type: Other
intervention name: Placebo
description: Patients will receive 2.5 ml normal saline in each tonsil
arm group label: Placebo
intervention type: Other
intervention name: General anesthesia
description: All patients will receive general anesthesia prior to infiltration
arm group label: Infiltration
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zoher Naja
role: Principal Investigator
affiliation: Makassed General Hospital
facility: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Zoher Naja
investigator title: Anesthesiologist
mesh term: Pain, Postoperative
mesh term: Anesthetics