<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/NCT04469868</url>
  </required_header>
  <id_info>
    <org_study_id>5866</org_study_id>
    <nct_id>NCT04469868</nct_id>
  </id_info>
  <brief_title>No Opioids PrescrIptions On Discharge After Surgery</brief_title>
  <acronym>NOPIOiDS</acronym>
  <official_title>Prospective Study of No Opioids PrescrIptions On Discharge After Surgery (NOPIOiDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albany Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albany Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Opioid analgesics are routinely prescribed for these patients for post-operative pain&#xD;
      control. Even a short exposure to opioids in opioid-naïve patients following minor or major&#xD;
      surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of&#xD;
      patients. The goal of the study to eliminate the use of outpatient opioids prescriptions&#xD;
      after major urologic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nearly 200 million opioid prescriptions are dispensed per year in the United States. Opioid&#xD;
      prescriptions given by medical providers are a major contributor to the opioid abuse&#xD;
      epidemic. Nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. Among&#xD;
      patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to&#xD;
      their abuse diagnosis and 51% had a family member who had an opioid prescription, Thus,&#xD;
      opioids prescriptions, which are often in excess of the need by the patient, are a major&#xD;
      contributor to this public health crisis.&#xD;
&#xD;
      The investigators devised a prospective intervention study to eliminate or significantly&#xD;
      reduced the use of opioids prescribed at hospital discharge after major urologic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All patients who undergo major urologic oncology surgery will be eligible to be enrolled.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opioids prescribing at hospital discharge</measure>
    <time_frame>30 days</time_frame>
    <description>Patients will be discharged with no or few opioids after surgery along with instruction on how to use non-opioid analgesic measures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All opioids prescriptions within 30 days of surgery</measure>
    <time_frame>30 days</time_frame>
    <description>The electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain after discharge</measure>
    <time_frame>7 days</time_frame>
    <description>Visual analog pain scale (which ranges from 0-10) will be completed daily for 7 days. Score of zero signifies no pain at all and a a score of 10 implies the worst pain ever experienced.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction score during home recovery</measure>
    <time_frame>7 days</time_frame>
    <description>Overall satisfaction score (0-100%) with post-operative pain, discomfort and recovery at home. A higher score signifies more satisfaction with pain control during the recovery process.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contact with healthcare facilities</measure>
    <time_frame>30 days</time_frame>
    <description>All phone calls to the clinic, unplanned visits, emergency room visits, hospital admissions will recorded and combined as a single measure of contact with any healthcare facility as a measure of resource utilization.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Opioid Use</condition>
  <condition>Prescription Drug Abuse and Dependency</condition>
  <condition>Surgery</condition>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>No opioids prescriptions at discharge</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive non-opioid analgesia, mostly over the counter, medications such as acetaminophen or ibuprofen. Opioids may be prescribed if the patients experience break through pain and call the office.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No opioids at discharge</intervention_name>
    <description>Patients who are being scheduled for any major urologic cancer surgery (open or laparoscopic) will be counselled regarding post-operative pain and measures taken during surgery and during hospital stay.&#xD;
They will be provided written information on these pain mitigation efforts and the adverse effects associated with opioids use and outpatient prescriptions.&#xD;
Patients will be discharged from the hospital without any opioids prescriptions and instructions to use non-opioids analgesics.&#xD;
Patients will complete a visual analog pain scale daily for 7 days after discharge from the hospital.&#xD;
Patients will be able to call the clinic at anytime for any post-operative pain issues.</description>
    <arm_group_label>No opioids prescriptions at discharge</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing major urologic cancer surgery, either open or laparoscopic,&#xD;
             will be included in the study.&#xD;
&#xD;
          -  This will include all open or laparoscopic or robotic surgery including radical&#xD;
             prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy,&#xD;
             nephron-ureterectomy, and similar procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with allergy or intolerance to NSAIDS may be excluded.&#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>Badar Mian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Albany Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Badar M. Mian, MD</last_name>
    <phone>515-262-7558</phone>
    <email>mianb@amc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Badar M. Mian, MD</last_name>
      <phone>518-262-7558</phone>
      <email>mianb@amc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>March 30, 2023</last_update_submitted>
  <last_update_submitted_qc>March 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albany Medical College</investigator_affiliation>
    <investigator_full_name>Badar M. Mian</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <keyword>Opioids</keyword>
  <keyword>Prescriptions</keyword>
  <keyword>Surgery</keyword>
  <keyword>Recovery</keyword>
  <keyword>Pain score</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</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/NCT04469868
org study id: 5866
nct id: NCT04469868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Opioid analgesics are routinely prescribed for these patients for post-operative pain
      control. Even a short exposure to opioids in opioid-naïve patients following minor or major
      surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of
      patients. The goal of the study to eliminate the use of outpatient opioids prescriptions
      after major urologic surgery.
Nearly 200 million opioid prescriptions are dispensed per year in the United States. Opioid
      prescriptions given by medical providers are a major contributor to the opioid abuse
      epidemic. Nearly 40% of opioid overdose-related deaths occur due to prescribed opioids. Among
      patients diagnosed with opiate dependence, 80% had received an opioid prescription prior to
      their abuse diagnosis and 51% had a family member who had an opioid prescription, Thus,
      opioids prescriptions, which are often in excess of the need by the patient, are a major
      contributor to this public health crisis.

      The investigators devised a prospective intervention study to eliminate or significantly
      reduced the use of opioids prescribed at hospital discharge after major urologic surgery.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All patients who undergo major urologic oncology surgery will be eligible to be enrolled.
primary purpose: Prevention
masking: None (Open Label)
measure: Opioids prescribing at hospital discharge
time frame: 30 days
description: Patients will be discharged with no or few opioids after surgery along with instruction on how to use non-opioid analgesic measures.
measure: All opioids prescriptions within 30 days of surgery
time frame: 30 days
description: The electronic medical records and pharmacy records will be monitored to identify if any additional opioids prescriptions were provided by any provider
measure: Post-operative pain after discharge
time frame: 7 days
description: Visual analog pain scale (which ranges from 0-10) will be completed daily for 7 days. Score of zero signifies no pain at all and a a score of 10 implies the worst pain ever experienced.
measure: Satisfaction score during home recovery
time frame: 7 days
description: Overall satisfaction score (0-100%) with post-operative pain, discomfort and recovery at home. A higher score signifies more satisfaction with pain control during the recovery process.
measure: Contact with healthcare facilities
time frame: 30 days
description: All phone calls to the clinic, unplanned visits, emergency room visits, hospital admissions will recorded and combined as a single measure of contact with any healthcare facility as a measure of resource utilization.
arm group label: No opioids prescriptions at discharge
arm group type: Experimental
description: Patients will receive non-opioid analgesia, mostly over the counter, medications such as acetaminophen or ibuprofen. Opioids may be prescribed if the patients experience break through pain and call the office.
intervention type: Behavioral
intervention name: No opioids at discharge
description: Patients who are being scheduled for any major urologic cancer surgery (open or laparoscopic) will be counselled regarding post-operative pain and measures taken during surgery and during hospital stay.
They will be provided written information on these pain mitigation efforts and the adverse effects associated with opioids use and outpatient prescriptions.
Patients will be discharged from the hospital without any opioids prescriptions and instructions to use non-opioids analgesics.
Patients will complete a visual analog pain scale daily for 7 days after discharge from the hospital.
Patients will be able to call the clinic at anytime for any post-operative pain issues.
arm group label: No opioids prescriptions at discharge
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Badar Mian, MD
role: Principal Investigator
affiliation: Albany Medical College
last name: Badar M. Mian, MD
phone: 515-262-7558
email: mianb@amc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Albany Medical College
investigator full name: Badar M. Mian
investigator title: Professor of Surgery
mesh term: Substance-Related Disorders
mesh term: Analgesics, Opioid
sharing ipd: No