<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/NCT04439396</url>
  </required_header>
  <id_info>
    <org_study_id>19-387</org_study_id>
    <nct_id>NCT04439396</nct_id>
  </id_info>
  <brief_title>Toradol (Ketorolac) in Breast Surgery to Reduce Pain &amp; Opioid Use</brief_title>
  <official_title>Use of Perioperative Ketorolac in Breast Surgery to Reduce Post Operative Pain and Opioid Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carilion Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Carilion Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</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>
      The purpose of this study is to investigate whether perioperative single-dose administration&#xD;
      of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby&#xD;
      decreasing post-operative opioid use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will perform a double blinded, prospective randomized trial of&#xD;
      perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures.&#xD;
      Patients will be randomized into three groups: group 1 will receive a perioperative dose of&#xD;
      ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will&#xD;
      be the control and receive a placebo of saline. Patients will be asked to complete a diary or&#xD;
      log of their average pain and pain medication use to be turned in at a 2 week follow up&#xD;
      visit.&#xD;
&#xD;
      The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac&#xD;
      (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the&#xD;
      immediate post-operative period, on post-operative day 1, and at their two-week follow up&#xD;
      appointment. If patients leave the same day then they will only have two pain score&#xD;
      assessments; on day of surgery and at their two-week follow up. Additionally, patients will&#xD;
      be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being&#xD;
      extreme pain) in morning and evenings using a patient diary for the two week post-op period.&#xD;
      The patient's opioid use will be measured by their opioid use during their hospital stay, as&#xD;
      well as how many prescription narcotic pills the patient used to manage their pain at home,&#xD;
      as documented using the patient diary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">January 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 30, 2023</primary_completion_date>
  <phase>Phase 1</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>randomized</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>double blind randomized trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of post-operative pain: Likert scale</measure>
    <time_frame>2 week post operation</time_frame>
    <description>This will be assessed by using a Likert scale(0=no pain to 10=extreme pain) for pain in the post-operative period before they are discharged. If patients are kept overnight then another pain assessment will be done. Additionally, patients will keep a 2-week diary of average pain in the morning and evening each day until their 2 week follow up visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of narcotic use</measure>
    <time_frame>2 weeks post operation</time_frame>
    <description>This will be assessed by calculating the Medial Morphine Equivalent (MME) in the post-operative period. This will include narcotics given while in the hospital and narcotics prescribed and used at home in the patient diary. Perioperative narcotic use will also be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication assessment</measure>
    <time_frame>2 weeks to 90 days post operation</time_frame>
    <description>Assess complications including, but not limited to, hematomas, GI issues (nausea, diarrhea, indigestion, heartburn), and headaches. This will be assessed by tracking any readmissions for hematoma evacuation or other complications reported at their post-op follow up visit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Breast Reduction</condition>
  <condition>Breast Reconstruction</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline injection administered during surgical procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose (15mg) Toradol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15mg ketorolac (toradol) administered during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose (30mg) Toradol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30mg ketorolac (toradol) administered during surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac Tromethamine</intervention_name>
    <description>nonsteroidal anti-inflammatory drug</description>
    <arm_group_label>High Dose (30mg) Toradol</arm_group_label>
    <arm_group_label>Low Dose (15mg) Toradol</arm_group_label>
    <other_name>Toradol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>saline fluid injection</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient consents to study&#xD;
&#xD;
          -  Adult females needing breast reconstruction or breast reduction (day surgeries)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known kidney disease&#xD;
&#xD;
          -  Patient does not consent&#xD;
&#xD;
          -  patients with history of bleeding disorder, peptic ulcer disease, renal disease, blood&#xD;
             thinners use, bariatric surgery and any other contraindications of Toradol use&#xD;
&#xD;
          -  patients currently taking aspirin&#xD;
&#xD;
          -  pregnant women (not standard to operate on this population anyway)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Thompson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carilion Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>James T. Thompson</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Carilion Clinic</investigator_affiliation>
    <investigator_full_name>James T Thompson</investigator_full_name>
    <investigator_title>Plastic and Reconstructive Surgeon</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Ketorolac Tromethamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04439396
org study id: 19-387
nct id: NCT04439396
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to investigate whether perioperative single-dose administration
      of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby
      decreasing post-operative opioid use.
The investigators will perform a double blinded, prospective randomized trial of
      perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures.
      Patients will be randomized into three groups: group 1 will receive a perioperative dose of
      ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will
      be the control and receive a placebo of saline. Patients will be asked to complete a diary or
      log of their average pain and pain medication use to be turned in at a 2 week follow up
      visit.

      The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac
      (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the
      immediate post-operative period, on post-operative day 1, and at their two-week follow up
      appointment. If patients leave the same day then they will only have two pain score
      assessments; on day of surgery and at their two-week follow up. Additionally, patients will
      be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being
      extreme pain) in morning and evenings using a patient diary for the two week post-op period.
      The patient's opioid use will be measured by their opioid use during their hospital stay, as
      well as how many prescription narcotic pills the patient used to manage their pain at home,
      as documented using the patient diary.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: double blind randomized trial
measure: Change of post-operative pain: Likert scale
time frame: 2 week post operation
description: This will be assessed by using a Likert scale(0=no pain to 10=extreme pain) for pain in the post-operative period before they are discharged. If patients are kept overnight then another pain assessment will be done. Additionally, patients will keep a 2-week diary of average pain in the morning and evening each day until their 2 week follow up visit.
measure: Change of narcotic use
time frame: 2 weeks post operation
description: This will be assessed by calculating the Medial Morphine Equivalent (MME) in the post-operative period. This will include narcotics given while in the hospital and narcotics prescribed and used at home in the patient diary. Perioperative narcotic use will also be recorded.
measure: Complication assessment
time frame: 2 weeks to 90 days post operation
description: Assess complications including, but not limited to, hematomas, GI issues (nausea, diarrhea, indigestion, heartburn), and headaches. This will be assessed by tracking any readmissions for hematoma evacuation or other complications reported at their post-op follow up visit.
arm group label: Control
arm group type: Placebo Comparator
description: Saline injection administered during surgical procedure
arm group label: Low Dose (15mg) Toradol
arm group type: Experimental
description: 15mg ketorolac (toradol) administered during surgery
arm group label: High Dose (30mg) Toradol
arm group type: Experimental
description: 30mg ketorolac (toradol) administered during surgery
intervention type: Drug
intervention name: Ketorolac Tromethamine
description: nonsteroidal anti-inflammatory drug
arm group label: High Dose (30mg) Toradol
arm group label: Low Dose (15mg) Toradol
other name: Toradol
intervention type: Other
intervention name: Saline
description: saline fluid injection
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: James Thompson
role: Principal Investigator
affiliation: Carilion Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Carilion Clinic
investigator full name: James T Thompson
investigator title: Plastic and Reconstructive Surgeon
mesh term: Ketorolac
mesh term: Ketorolac Tromethamine
sharing ipd: No