<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/NCT03799757</url>
  </required_header>
  <id_info>
    <org_study_id>malhussini001</org_study_id>
    <nct_id>NCT03799757</nct_id>
  </id_info>
  <brief_title>Using Bupivacaine Locally in the Mastectomy Drains to Control Postoperative Pain</brief_title>
  <official_title>Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      in this study we are investigating the role of instillation of Bupivacaine through surgical&#xD;
      drains at the end of mastectomy surgeries in controlling post operative pain and decreasing&#xD;
      their pain killers requirement in the early postoperative period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25%&#xD;
      bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains&#xD;
      were clamped for 20 minutes.&#xD;
&#xD;
      in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and&#xD;
      chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.&#xD;
      (placebo group) patients and health care providers were blinded as regard the study group&#xD;
      patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the&#xD;
      patient is annoyed from the pain- was assessed two and four hours post-operative then every&#xD;
      four hours thereafter.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>Phase 4</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual analogue pain score</measure>
    <time_frame>first 24 hours</time_frame>
    <description>The intensity of pain will be assessed by the VAS score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of demands for analgesic</measure>
    <time_frame>First 24 hours</time_frame>
    <description>How many times the patient will require analgesics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timing of first demand for analgesic</measure>
    <time_frame>First 24 hours</time_frame>
    <description>Time lapse between recovery from surgery and first demand for analgesic</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>40ml of 0.25% bupivacaine</intervention_name>
    <arm_group_label>Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>40ml of 0.9% normal saline</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        female patients with unilateral breast cancer candidates for total mastectomy and axillary&#xD;
        dissection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male patients&#xD;
&#xD;
          2. Bilateral breast cancer.&#xD;
&#xD;
          3. Patients with a history of a long duration of NSAID intake or other painkillers, drug&#xD;
             abuse&#xD;
&#xD;
          4. Patients with chest wall pain like Tietze syndrome, history of angina pectoris or&#xD;
             recent HZV infection.&#xD;
&#xD;
          5. Patients with known psychological or mental problems.&#xD;
&#xD;
          6. Patients who were not exposed to axillary dissection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>only females with breast cancer who were subjected to mastectomy with axillary nodal dissection were enrolled</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud A Alhussini, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>faculty of medicine , univeristy of alexandria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine, Main Univeristy Hospital</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Mahmoud A. Alhussini</investigator_full_name>
    <investigator_title>lecturer surgical oncology</investigator_title>
  </responsible_party>
  <keyword>bupivacaine</keyword>
  <keyword>Post-mastectomy acute pain</keyword>
  <keyword>Wound instillation</keyword>
  <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>Bupivacaine</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/NCT03799757
org study id: malhussini001
nct id: NCT03799757
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
in this study we are investigating the role of instillation of Bupivacaine through surgical
      drains at the end of mastectomy surgeries in controlling post operative pain and decreasing
      their pain killers requirement in the early postoperative period
patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25%
      bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains
      were clamped for 20 minutes.

      in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and
      chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
      (placebo group) patients and health care providers were blinded as regard the study group
      patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the
      patient is annoyed from the pain- was assessed two and four hours post-operative then every
      four hours thereafter.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Visual analogue pain score
time frame: first 24 hours
description: The intensity of pain will be assessed by the VAS score
measure: Number of demands for analgesic
time frame: First 24 hours
description: How many times the patient will require analgesics
measure: Timing of first demand for analgesic
time frame: First 24 hours
description: Time lapse between recovery from surgery and first demand for analgesic
arm group label: Bupivacaine
arm group type: Active Comparator
description: The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
arm group label: Placebo
arm group type: Placebo Comparator
description: The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group)
intervention type: Drug
intervention name: 40ml of 0.25% bupivacaine
arm group label: Bupivacaine
intervention type: Drug
intervention name: 40ml of 0.9% normal saline
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: only females with breast cancer who were subjected to mastectomy with axillary nodal dissection were enrolled
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mahmoud A Alhussini, md
role: Principal Investigator
affiliation: faculty of medicine , univeristy of alexandria
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Mahmoud A. Alhussini
investigator title: lecturer surgical oncology
mesh term: Pain, Postoperative
mesh term: Bupivacaine