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/NCT05965492</url>
    </required_header>
    <id_info>
      <org_study_id>20230423</org_study_id>
      <nct_id>NCT05965492</nct_id>
    </id_info>
    <brief_title>Multimodal Pain Package vs. Regular Formulation for Pain Management in Ambulatory Spinal Surgery</brief_title>
    <official_title>Optimal Multimodal Pain Management Package Versus Regular Bottled Pain Formulation for Outpatient Use Following Microdiscectomies , Foraminotomies, and Spinal Decompressions: A Randomized Control Trial Comparing Two Strategies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Miami</source>
    <oversight_info>
      <has_dmc>No</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 research is to compare two outpatient pain management strategies in&#xD;
        patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal&#xD;
        decompressions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <phase>Phase 3</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adherence measured by the self-report medication nonadherence scale</measure>
      <time_frame>up to 7 days</time_frame>
      <description>Adherence will be measured using a Likert scale ranging from &quot;never&quot; indicating that the participant followed all instructions and adhered to the medication to &quot;all the time. &quot;indicating that the participant never followed instructions and did not take the medication.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Satisfaction measured by Satisfaction Likert Scale</measure>
      <time_frame>up to 7 days</time_frame>
      <description>Scores range from &quot;0&quot; not satisfied to &quot;10&quot; very satisfied</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ease of use as measured by Likert Scale</measure>
      <time_frame>up to 7 days</time_frame>
      <description>Scores ranges from &quot;strongly disagree to Strongly agree&quot; regarding the ease of use of the medication package.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of pain pills</measure>
      <time_frame>up to 7 days</time_frame>
      <description>Count of pills taken by participants</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Spinal Disorder</condition>
    <arm_group>
      <arm_group_label>Bottled pain formulations Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Multi-Modal regimen Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Acetaminophen</intervention_name>
      <description>Day 1 and Day 2: 1000 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 3000 mg.&#xD;
  Day 3 and Day 4: 825 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 2475 mg.&#xD;
  Day 5: 500 mg two times a day and 325 mg once a day administered via tablet by mouth for a total cumulative daily dose of 1325 mg.&#xD;
  Day 6: 500 mg once a day and 325mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1150 mg.&#xD;
  Day 7: 500 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1000 mg.</description>
      <arm_group_label>Bottled pain formulations Group</arm_group_label>
      <arm_group_label>Multi-Modal regimen Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Celebrex</intervention_name>
      <description>Day 1: 200 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 400 mg.&#xD;
  Day 2 and Day 3: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.&#xD;
  Day 4: 100 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.&#xD;
  Day 5: 50 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.&#xD;
  Not prescribed on Days 6 and 7.</description>
      <arm_group_label>Bottled pain formulations Group</arm_group_label>
      <arm_group_label>Multi-Modal regimen Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gabapentin</intervention_name>
      <description>Day 1 and Day 2: 300 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 900 mg.&#xD;
  Day 3: 200 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 600 mg.&#xD;
  Day 4: 200 mg two times a day and 100mg once a day administered via tablet by mouth for a total cumulative daily dose of 500 mg.&#xD;
  Day 5: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.&#xD;
  Day 6: 100 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.&#xD;
  Day 7: 100 mg once a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.</description>
      <arm_group_label>Bottled pain formulations Group</arm_group_label>
      <arm_group_label>Multi-Modal regimen Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Famotidine</intervention_name>
      <description>Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.</description>
      <arm_group_label>Bottled pain formulations Group</arm_group_label>
      <arm_group_label>Multi-Modal regimen Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Decadron</intervention_name>
      <description>Day 1: 4 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 12 mg.&#xD;
  Day 2: 4 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 8 mg.&#xD;
  Day 3: 2 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 4 mg.&#xD;
  Not prescribed on Days 4 through 7.</description>
      <arm_group_label>Bottled pain formulations Group</arm_group_label>
      <arm_group_label>Multi-Modal regimen Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxycodone</intervention_name>
      <description>A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.</description>
      <arm_group_label>Bottled pain formulations Group</arm_group_label>
      <arm_group_label>Multi-Modal regimen Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults: males or non-pregnant females.&#xD;
  &#xD;
            -  Patients undergoing ambulatory microdiscectomies, foraminotomies, and spinal cord&#xD;
               decompressions requiring pain control analgesics.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Active severe liver disease&#xD;
  &#xD;
            -  Chronic kidney disease 3a-5 (moderate to severe)&#xD;
  &#xD;
            -  Chronic obstructive pulmonary disease with impaired pulmonary function&#xD;
  &#xD;
            -  Chronic steroid use&#xD;
  &#xD;
            -  Chronic opioid use&#xD;
  &#xD;
            -  Current use of narcotics&#xD;
  &#xD;
            -  Allergy to sulfonamides&#xD;
  &#xD;
            -  Allergy to NSAIDs&#xD;
  &#xD;
            -  Allergy to Aspirin&#xD;
  &#xD;
            -  Allergy to Tylenol&#xD;
  &#xD;
            -  Allergy to Gabapentins&#xD;
  &#xD;
            -  Allergy to H2 blockers (cimetidine, famotidine)&#xD;
  &#xD;
            -  Allergy to steroid&#xD;
  &#xD;
            -  Current use of gabapentins for any medical condition&#xD;
  &#xD;
            -  Inability to be discharged home on the day of surgery&#xD;
  &#xD;
            -  Inability to swallow pills&#xD;
  &#xD;
            -  Myasthenia gravis&#xD;
  &#xD;
            -  History of gastrointestinal ulcers or stomach bleeding&#xD;
  &#xD;
            -  Have any condition that, in the investigator's opinion, will compromise the well-being&#xD;
               of the patient or the study, or prevent the patient from meeting or performing study&#xD;
               requirements.&#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>Yiliam Yiliam, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Professor of Clinical</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yiliam Rodriguez, MD</last_name>
      <phone>(305) 5855456</phone>
      <email>yrodriguez4@miami.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Miami</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Antor</last_name>
        <phone>305-587-7677</phone>
        <email>mantor@miami.edu</email>
      </contact>
      <investigator>
        <last_name>Yiliam Rodriguez, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Yiliam Rodriguez</investigator_full_name>
      <investigator_title>Professor of Clinical</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Spinal Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetaminophen</mesh_term>
      <mesh_term>Celecoxib</mesh_term>
      <mesh_term>Oxycodone</mesh_term>
      <mesh_term>Gabapentin</mesh_term>
      <mesh_term>Famotidine</mesh_term>
    </intervention_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/NCT05965492
  org study id: 20230423
  nct id: NCT05965492
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this research is to compare two outpatient pain management strategies in
        patients undergoing spinal surgeries such as microdiscectomies, foraminotomies, and spinal
        decompressions.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Adherence measured by the self-report medication nonadherence scale
  time frame: up to 7 days
  description: Adherence will be measured using a Likert scale ranging from "never" indicating that the participant followed all instructions and adhered to the medication to "all the time. "indicating that the participant never followed instructions and did not take the medication.
  measure: Satisfaction measured by Satisfaction Likert Scale
  time frame: up to 7 days
  description: Scores range from "0" not satisfied to "10" very satisfied
  measure: Ease of use as measured by Likert Scale
  time frame: up to 7 days
  description: Scores ranges from "strongly disagree to Strongly agree" regarding the ease of use of the medication package.
  measure: Number of pain pills
  time frame: up to 7 days
  description: Count of pills taken by participants
  arm group label: Bottled pain formulations Group
  arm group type: Active Comparator
  description: Participants in this group will use the standard-of-care medication treatment for ambulatory spinal surgery prescribed to them in different bottles for 7 days.
  arm group label: Multi-Modal regimen Group
  arm group type: Experimental
  description: Participants in this group will receive the same drugs used during the standard-of-care treatment for ambulatory spinal surgery. However, the drugs will be prescribed using a simple multimodal medication pre-formulated package for 7 days.
  intervention type: Drug
  intervention name: Acetaminophen
  description: Day 1 and Day 2: 1000 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 3000 mg.
  Day 3 and Day 4: 825 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 2475 mg.
  Day 5: 500 mg two times a day and 325 mg once a day administered via tablet by mouth for a total cumulative daily dose of 1325 mg.
  Day 6: 500 mg once a day and 325mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1150 mg.
  Day 7: 500 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 1000 mg.
  arm group label: Bottled pain formulations Group
  arm group label: Multi-Modal regimen Group
  intervention type: Drug
  intervention name: Celebrex
  description: Day 1: 200 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 400 mg.
  Day 2 and Day 3: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
  Day 4: 100 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
  Day 5: 50 mg twice a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
  Not prescribed on Days 6 and 7.
  arm group label: Bottled pain formulations Group
  arm group label: Multi-Modal regimen Group
  intervention type: Drug
  intervention name: Gabapentin
  description: Day 1 and Day 2: 300 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 900 mg.
  Day 3: 200 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 600 mg.
  Day 4: 200 mg two times a day and 100mg once a day administered via tablet by mouth for a total cumulative daily dose of 500 mg.
  Day 5: 100 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 300 mg.
  Day 6: 100 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 200 mg.
  Day 7: 100 mg once a day administered via tablet by mouth for a total cumulative daily dose of 100 mg.
  arm group label: Bottled pain formulations Group
  arm group label: Multi-Modal regimen Group
  intervention type: Drug
  intervention name: Famotidine
  description: Day 1- Day 7: 20 mg once a day administered via tablet by mouth for a total cumulative daily dose of 20 mg.
  arm group label: Bottled pain formulations Group
  arm group label: Multi-Modal regimen Group
  intervention type: Drug
  intervention name: Decadron
  description: Day 1: 4 mg three times a day administered via tablet by mouth for a total cumulative daily dose of 12 mg.
  Day 2: 4 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 8 mg.
  Day 3: 2 mg two times a day administered via tablet by mouth for a total cumulative daily dose of 4 mg.
  Not prescribed on Days 4 through 7.
  arm group label: Bottled pain formulations Group
  arm group label: Multi-Modal regimen Group
  intervention type: Drug
  intervention name: Oxycodone
  description: A prescription of oxycodone as per standard of care will be provided to participants in case of breakthrough pain.
  arm group label: Bottled pain formulations Group
  arm group label: Multi-Modal regimen Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yiliam Yiliam, MD
  role: Principal Investigator
  affiliation: Professor of Clinical
  last name: Yiliam Rodriguez, MD
  phone: (305) 5855456
  email: yrodriguez4@miami.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Yiliam Rodriguez
  investigator title: Professor of Clinical
  mesh term: Spinal Diseases
  mesh term: Acetaminophen
  mesh term: Celecoxib
  mesh term: Oxycodone
  mesh term: Gabapentin
  mesh term: Famotidine
  sharing ipd: No