<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/NCT04491617</url>
  </required_header>
  <id_info>
    <org_study_id>20-682</org_study_id>
    <nct_id>NCT04491617</nct_id>
  </id_info>
  <brief_title>STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery Trial</brief_title>
  <acronym>STOP-PAIN</acronym>
  <official_title>STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery: A Randomized Controlled, Non-inferiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al.&#xD;
      demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills&#xD;
      were never taken. Disturbingly, 45% of patients who did not take opioids at all on their day&#xD;
      of discharge were discharged with an opioid prescription (Chen et al). Recent initiatives&#xD;
      have attempted to utilize restrictive opioid prescribing protocols for postoperative pain&#xD;
      management in which patients were prescribed a limited number of opioid tablets (Hallway et&#xD;
      al) or prescribed opioids only if they were used as an inpatient (Mark et al). These&#xD;
      well-conducted studies show that restrictive opioid prescribing policies achieve the goal of&#xD;
      reducing excess opioid exposure without causing undue harm, inconvenience or dissatisfaction&#xD;
      among patients.&#xD;
&#xD;
      The objective of this study is to determine if a restrictive opioid prescription protocol (in&#xD;
      which patients are not prescribed postoperative opioids unless they request them) is&#xD;
      acceptable to patients after ambulatory and major urogynecologic surgery, compared to&#xD;
      standard opioid prescribing practices. The study investigators believe that physicians can&#xD;
      capitalize on the new ability to electronically prescribe opioids for patients who require&#xD;
      them, to prevent over-prescribing without impacting patient care. The study also intends to&#xD;
      describe postoperative opioid use patterns in the urogynecologic population, including&#xD;
      factors predictive of opioid use and non-use. The results of this research will have a&#xD;
      significant and timely impact by helping to reduce opioid overprescribing and informing&#xD;
      future prescribing guidelines in the field of urogynecology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aims&#xD;
&#xD;
      Aim 1. To compare patient satisfaction and pain control using two different opioid&#xD;
      prescribing protocols.&#xD;
&#xD;
      The study investigators hypothesize that postoperative pain control and satisfaction will be&#xD;
      non-inferior between patients not routinely prescribed opioids after surgery and those&#xD;
      prescribed a standard quantity. Participants will be asked to rate their pain control during&#xD;
      the first 7 postoperative days with validated questionnaires. Participants' satisfaction with&#xD;
      pain control will be evaluated at their postoperative visit.&#xD;
&#xD;
      Aim 2. To examine opioid use patterns after ambulatory and major urogynecologic surgery.&#xD;
&#xD;
      The study investigators hypothesize that most postoperative patients will use few or no&#xD;
      opioids after urogynecologic surgery, regardless of prescribing protocol. All participants&#xD;
      will receive thorough counseling with detailed instructions on non-opioid pain management, as&#xD;
      well as multimodal analgesia via ERAS protocol during the perioperative period. Participants&#xD;
      will be asked to log their opioid and non-opioid medication use in the first postoperative&#xD;
      week. The investigators will also assess the number of requests for opioid prescription (in&#xD;
      those randomized to the restrictive protocol) and opioid refills (from patients in the&#xD;
      standard protocol).&#xD;
&#xD;
      Aim 3. To determine patient and perioperative factors associated with opioid use after&#xD;
      urogynecologic surgery.&#xD;
&#xD;
      The study investigators plan to collect and analyze demographic, clinical and psychometric&#xD;
      data on all participants with the goal of predicting analgesic needs and opioid use after&#xD;
      urogynecologic surgery. Results from this study will guide surgeons on how to tailor opioid&#xD;
      prescriptions to the needs of each patient, based off individual patient and perioperative&#xD;
      characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Actual">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction with pain control at 6 week postoperative visit</measure>
    <time_frame>6-weeks</time_frame>
    <description>Patient satisfaction with postoperative pain control and how pain expectations were met will be assessed with a 5-point Likert scale at the postoperative visit (&quot;Overall, how satisfied were you with your postoperative pain medication?&quot; [ranked 1- Very Dissatisfied to 5- Very Satisfied] and &quot;With regard to your expectations before surgery, did you have the amount of pain you expected, more pain, or less pain?&quot; [ranked 1- Much less pain than I expected to 5- Much more pain than I expected]).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain level scores during first postoperative week</measure>
    <time_frame>1-week</time_frame>
    <description>Patients will be asked to report their pain level for the first 7 days postoperatively. Pain levels will be assessed using questions 1, 2 and 4 from the Modified Surgical Pain Scales (SPS), which measures pain at rest, during normal activities and quantifies unpleasantness of worst pain using an 11-point numeric rating score, with 0 representing 'No pain sensation' and 10 representing 'Most intense pain imaginable'. Higher scores indicate a greater amount of pain. REDCap or paper surveys will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of pain medication tablets used</measure>
    <time_frame>1-week</time_frame>
    <description>Participants will be asked to log opioid and non-opioid medication in number of tablets used during the first postoperative week with either REDCap or paper surveys.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of requests for new opioid prescription or refills</measure>
    <time_frame>6-weeks</time_frame>
    <description>Investigators will track the number of requests for opioid prescriptions and opioid refills during the 6 week postoperative period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Opioid Use</condition>
  <condition>Prolapse; Female</condition>
  <condition>Incontinence</condition>
  <arm_group>
    <arm_group_label>Standard Opioid Protocol (Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Restrictive Opioid Protocol (Intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard opioid prescribing</intervention_name>
    <description>Patients are routinely prescribed opioid medications in addition to non-opioids.</description>
    <arm_group_label>Standard Opioid Protocol (Control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Restrictive opioid prescribing</intervention_name>
    <description>Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.</description>
    <arm_group_label>Restrictive Opioid Protocol (Intervention)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than 18 years old&#xD;
&#xD;
          -  Access to ancillary care, including phone advice, nurse and outpatient clinic numbers&#xD;
&#xD;
          -  Transportation to outpatient clinic or ability to access Virtual Care Visits&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  Has decision-making capacity and able to provide consent for research participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of substance abuse disorder&#xD;
&#xD;
          -  Chronic opioid use&#xD;
&#xD;
          -  Score greater than or equal to 30 on Pain Catastrophizing Scale&#xD;
&#xD;
          -  Allergy (not intolerance) to greater than or equal to 2 opioids&#xD;
&#xD;
          -  Contraindications to both NSAIDs and acetaminophen&#xD;
&#xD;
          -  Surgery scheduled on Friday or before major federal holiday&#xD;
&#xD;
          -  Patients undergoing concomitant colorectal procedures&#xD;
&#xD;
          -  Patients with perioperative complication (such as iatrogenic bowel and bladder injury,&#xD;
             hemorrhage, unanticipated laparotomy or ICU admission)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cecile A Ferrando, M.D., M.P.H.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.</citation>
    <PMID>27631771</PMID>
  </reference>
  <reference>
    <citation>Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.</citation>
    <PMID>29238810</PMID>
  </reference>
  <reference>
    <citation>Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.</citation>
    <PMID>31154092</PMID>
  </reference>
  <reference>
    <citation>Mark J, Argentieri DM, Gutierrez CA, Morrell K, Eng K, Hutson AD, Mayor P, Szender JB, Starbuck K, Lynam S, Blum B, Akers S, Lele S, Paragh G, Odunsi K, de Leon-Casasola O, Frederick PJ, Zsiros E. Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. doi: 10.1001/jamanetworkopen.2018.5452.</citation>
    <PMID>30646274</PMID>
  </reference>
  <reference>
    <citation>Davidson ERW, Paraiso MFR, Walters MD, Propst K, Ridgeway B, Yao M, Ferrando CA. A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair. Am J Obstet Gynecol. 2020 Oct;223(4):547.e1-547.e12. doi: 10.1016/j.ajog.2020.03.017. Epub 2020 Mar 19. Erratum In: Am J Obstet Gynecol. 2021 Jun;224(6):619.</citation>
    <PMID>32199926</PMID>
  </reference>
  <reference>
    <citation>Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa.</citation>
    <PMID>22777367</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>June 26, 2023</last_update_submitted>
  <last_update_submitted_qc>June 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioids</keyword>
  <keyword>Gynecology</keyword>
  <keyword>Pain control</keyword>
  <keyword>Prolapse</keyword>
  <keyword>Incontinence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</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>
  <!-- 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/NCT04491617
org study id: 20-682
nct id: NCT04491617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al.
      demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills
      were never taken. Disturbingly, 45% of patients who did not take opioids at all on their day
      of discharge were discharged with an opioid prescription (Chen et al). Recent initiatives
      have attempted to utilize restrictive opioid prescribing protocols for postoperative pain
      management in which patients were prescribed a limited number of opioid tablets (Hallway et
      al) or prescribed opioids only if they were used as an inpatient (Mark et al). These
      well-conducted studies show that restrictive opioid prescribing policies achieve the goal of
      reducing excess opioid exposure without causing undue harm, inconvenience or dissatisfaction
      among patients.

      The objective of this study is to determine if a restrictive opioid prescription protocol (in
      which patients are not prescribed postoperative opioids unless they request them) is
      acceptable to patients after ambulatory and major urogynecologic surgery, compared to
      standard opioid prescribing practices. The study investigators believe that physicians can
      capitalize on the new ability to electronically prescribe opioids for patients who require
      them, to prevent over-prescribing without impacting patient care. The study also intends to
      describe postoperative opioid use patterns in the urogynecologic population, including
      factors predictive of opioid use and non-use. The results of this research will have a
      significant and timely impact by helping to reduce opioid overprescribing and informing
      future prescribing guidelines in the field of urogynecology.
Specific Aims

      Aim 1. To compare patient satisfaction and pain control using two different opioid
      prescribing protocols.

      The study investigators hypothesize that postoperative pain control and satisfaction will be
      non-inferior between patients not routinely prescribed opioids after surgery and those
      prescribed a standard quantity. Participants will be asked to rate their pain control during
      the first 7 postoperative days with validated questionnaires. Participants' satisfaction with
      pain control will be evaluated at their postoperative visit.

      Aim 2. To examine opioid use patterns after ambulatory and major urogynecologic surgery.

      The study investigators hypothesize that most postoperative patients will use few or no
      opioids after urogynecologic surgery, regardless of prescribing protocol. All participants
      will receive thorough counseling with detailed instructions on non-opioid pain management, as
      well as multimodal analgesia via ERAS protocol during the perioperative period. Participants
      will be asked to log their opioid and non-opioid medication use in the first postoperative
      week. The investigators will also assess the number of requests for opioid prescription (in
      those randomized to the restrictive protocol) and opioid refills (from patients in the
      standard protocol).

      Aim 3. To determine patient and perioperative factors associated with opioid use after
      urogynecologic surgery.

      The study investigators plan to collect and analyze demographic, clinical and psychometric
      data on all participants with the goal of predicting analgesic needs and opioid use after
      urogynecologic surgery. Results from this study will guide surgeons on how to tailor opioid
      prescriptions to the needs of each patient, based off individual patient and perioperative
      characteristics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient satisfaction with pain control at 6 week postoperative visit
time frame: 6-weeks
description: Patient satisfaction with postoperative pain control and how pain expectations were met will be assessed with a 5-point Likert scale at the postoperative visit ("Overall, how satisfied were you with your postoperative pain medication?" [ranked 1- Very Dissatisfied to 5- Very Satisfied] and "With regard to your expectations before surgery, did you have the amount of pain you expected, more pain, or less pain?" [ranked 1- Much less pain than I expected to 5- Much more pain than I expected]).
measure: Pain level scores during first postoperative week
time frame: 1-week
description: Patients will be asked to report their pain level for the first 7 days postoperatively. Pain levels will be assessed using questions 1, 2 and 4 from the Modified Surgical Pain Scales (SPS), which measures pain at rest, during normal activities and quantifies unpleasantness of worst pain using an 11-point numeric rating score, with 0 representing 'No pain sensation' and 10 representing 'Most intense pain imaginable'. Higher scores indicate a greater amount of pain. REDCap or paper surveys will be used.
measure: Number of pain medication tablets used
time frame: 1-week
description: Participants will be asked to log opioid and non-opioid medication in number of tablets used during the first postoperative week with either REDCap or paper surveys.
measure: Number of requests for new opioid prescription or refills
time frame: 6-weeks
description: Investigators will track the number of requests for opioid prescriptions and opioid refills during the 6 week postoperative period.
arm group label: Standard Opioid Protocol (Control)
arm group type: Active Comparator
description: Standard postoperative medications (opioids and non-opioids) are prescribed upon discharge after surgery
arm group label: Restrictive Opioid Protocol (Intervention)
arm group type: Experimental
description: Only non-opioid analgesics (i.e. ibuprofen and acetaminophen) are prescribed upon discharge after surgery. Patients are allowed to request an opioid prescription if they so desire
intervention type: Other
intervention name: Standard opioid prescribing
description: Patients are routinely prescribed opioid medications in addition to non-opioids.
arm group label: Standard Opioid Protocol (Control)
intervention type: Other
intervention name: Restrictive opioid prescribing
description: Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
arm group label: Restrictive Opioid Protocol (Intervention)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cecile A Ferrando, M.D., M.P.H.
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Hill MV, McMahon ML, Stucke RS, Barth RJ Jr. Wide Variation and Excessive Dosage of Opioid Prescriptions for Common General Surgical Procedures. Ann Surg. 2017 Apr;265(4):709-714. doi: 10.1097/SLA.0000000000001993.
PMID: 27631771
citation: Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
PMID: 29238810
citation: Hallway A, Vu J, Lee J, Palazzolo W, Waljee J, Brummett C, Englesbe M, Howard R. Patient Satisfaction and Pain Control Using an Opioid-Sparing Postoperative Pathway. J Am Coll Surg. 2019 Sep;229(3):316-322. doi: 10.1016/j.jamcollsurg.2019.04.020. Epub 2019 May 30.
PMID: 31154092
citation: Mark J, Argentieri DM, Gutierrez CA, Morrell K, Eng K, Hutson AD, Mayor P, Szender JB, Starbuck K, Lynam S, Blum B, Akers S, Lele S, Paragh G, Odunsi K, de Leon-Casasola O, Frederick PJ, Zsiros E. Ultrarestrictive Opioid Prescription Protocol for Pain Management After Gynecologic and Abdominal Surgery. JAMA Netw Open. 2018 Dec 7;1(8):e185452. doi: 10.1001/jamanetworkopen.2018.5452.
PMID: 30646274
citation: Davidson ERW, Paraiso MFR, Walters MD, Propst K, Ridgeway B, Yao M, Ferrando CA. A randomized controlled noninferiority trial of reduced vs routine opioid prescription after prolapse repair. Am J Obstet Gynecol. 2020 Oct;223(4):547.e1-547.e12. doi: 10.1016/j.ajog.2020.03.017. Epub 2020 Mar 19. Erratum In: Am J Obstet Gynecol. 2021 Jun;224(6):619.
PMID: 32199926
citation: Barber MD, Janz N, Kenton K, Hsu Y, Greer WJ, Dyer K, White A, Meikle S, Ye W. Validation of the surgical pain scales in women undergoing pelvic reconstructive surgery. Female Pelvic Med Reconstr Surg. 2012 Jul-Aug;18(4):198-204. doi: 10.1097/SPV.0b013e31825d65aa.
PMID: 22777367
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Analgesics, Opioid