<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/NCT04444830</url>
  </required_header>
  <id_info>
    <org_study_id>19.1351</org_study_id>
    <nct_id>NCT04444830</nct_id>
  </id_info>
  <brief_title>Sprix for Postoperative Pain Control Following Gynecologic Surgery</brief_title>
  <official_title>Can Intranasal Ketorolac Tromethamine Prescribed Postoperatively After Major Female Pelvic Reconstructive Surgery Reduce Consumption of Prescribed Narcotics?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Louisville</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Louisville</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients'&#xD;
      perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of&#xD;
      opioids that be may prescribed after acute injury, for chronic conditions and following&#xD;
      surgery the healthcare industry as a whole continues to search for alternative medications&#xD;
      that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition.&#xD;
      To that end this study has the following aims:&#xD;
&#xD;
        1. To evaluate the amount of opioids consumed following minimally invasive, female pelvic&#xD;
           surgery when patients' postoperative pain is managed via:&#xD;
&#xD;
             1. Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)&#xD;
&#xD;
             2. Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough&#xD;
                pain (Sprix protocol)&#xD;
&#xD;
        2. Patient satisfaction with the aforementioned methods&#xD;
&#xD;
        3. Evaluate and compare pain scores via validated questionnaire&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Primary:&#xD;
&#xD;
      1. Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less&#xD;
      Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following&#xD;
      minimally invasive female pelvic surgery.&#xD;
&#xD;
      Secondary:&#xD;
&#xD;
        1. Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of&#xD;
           pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes&#xD;
           maximum experience of pain&#xD;
&#xD;
        2. Patients in the Sprix protocol will have lower numeric pain score and on POD#4&#xD;
&#xD;
        3. Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores&#xD;
           on POD#1&#xD;
&#xD;
        4. Patients in the Sprix protocol will have higher QoR-40 scores on POD#4&#xD;
&#xD;
        5. Patients will not have any significant difference in overall surgical satisfaction on&#xD;
           POD#1 and POD#4 using a numerical satisfaction score&#xD;
&#xD;
        6. Patients in the Sprix protocol will be more likely to consume no narcotics at all once&#xD;
           discharged to home&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study never opened to enrollment. Study never IRB approved.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2021</start_date>
  <completion_date type="Actual">September 21, 2021</completion_date>
  <primary_completion_date type="Actual">September 21, 2021</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>
    <intervention_model_description>This is a multi-center, non-blinded, randomized control trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine mEqs</measure>
    <time_frame>As measured from the day of surgery to 4 days post operative</time_frame>
    <description>The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Day of surgery to 4 days postoperative</time_frame>
    <description>Evaluate patient satisfaction using the validated QoR 40 (Quality of Recovery) Scale - wherein a minimum score of 40 indicates that a patient perceives there recovery to be very poor and a maximum score of 200 indicates that the patient perceives that the quality of their recovery is excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's perception of current pain</measure>
    <time_frame>Day of surgery to 4 days postoperatively</time_frame>
    <description>The patient's pain will be subjectively scaled on a 0 (indicating no pain) to 10 (indicating maximum/severe pain) scale. The patient will be asked to scale their pain preoperatively, on postoperative day #1 and on Postoperative day #4</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Post Operative Pain Control</condition>
  <condition>Narcotic Use</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Urinary Incontinence , Stress</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Standard</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>To compare the total amount of opioid consumption, as measured by morphine mEq, consumed in patients immediately postoperative from minimally invasive female pelvic reconstructive surgery - they will be prescribed a &quot;standard&quot; postoperative regimen of Acetaminophen 650 mg PO q 6-8 hours + Ibuprofen 600 mg PO q 6-8 hours + rescue narcotics (Oxycodone 5-10 mg PO q 4-6 hours or if allergic to Oxycodone, Norco 5-10mg/325mg PO q 4-6 hours) for breakthrough pain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sprix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To compare the total amount of opioid consumption, as measured by morphine mEq, consumed in patients immediately postoperative from minimally invasive female pelvic reconstructive surgery - they will be prescribed regimen of Sprix 30.5mg Intranasal q 6-8 hour up to 4 times daily + Acetaminophen 650 mg PO q 6- 8 hours + rescue narcotics (as above) for breakthrough pain during the day of surgery and the following 4 postoperative days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sprix</intervention_name>
    <description>Intranasal Ketorolac - used as directed for an appropriate, previously established indication</description>
    <arm_group_label>Sprix</arm_group_label>
    <other_name>Intranasal Ketorolac</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years of age&#xD;
&#xD;
          2. Weight ≥ 110lbs&#xD;
&#xD;
          3. English Speaking and Reading&#xD;
&#xD;
          4. All consecutive, consenting female patients undergoing Pelvic Organ Prolapse (POP)&#xD;
             surgery - vaginal prolapse surgery, laparoscopic vaginal prolapse surgery or robotic&#xD;
             assisted vaginal prolapse surgery - with or without Bilateral or Unilateral&#xD;
             Salpingoopherectomy, with or without concomitant hysterectomy, with or without urinary&#xD;
             anti-incontinence surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients taking opioids chronically at the time of surgery&#xD;
&#xD;
          2. History of Coronary Artery Bypass Graft (CABG)&#xD;
&#xD;
          3. History of peptic ulcer disease or bleeding in the stomach or intestines&#xD;
&#xD;
          4. History of asthma attack, hives, or other allergic reaction with aspirin or any other&#xD;
             Non-Steroidal Anti-inflammatory Drug (NSAID)&#xD;
&#xD;
          5. Uncontrolled hypertension at the time of consent and/or surgery&#xD;
&#xD;
          6. History of renal impairment as defined by blood creatinine of 1.1 or greater at any&#xD;
             time&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients - all patients in the study are those that will undergo/have undergone female pelvic surgery (Urogynecology)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Louisville Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564. Erratum In: Curr Med Res Opin. 2012 Jun;28(6):1052.</citation>
    <PMID>20557145</PMID>
  </reference>
  <reference>
    <citation>Pergolizzi JV Jr, Taylor R Jr, Raffa RB. Intranasal ketorolac as part of a multimodal approach to postoperative pain. Pain Pract. 2015 Apr;15(4):378-88. doi: 10.1111/papr.12239. Epub 2014 Aug 28.</citation>
    <PMID>25169467</PMID>
  </reference>
  <reference>
    <citation>Pollack CV Jr, Diercks DB, Thomas SH, Shapiro NI, Fanikos J, Mace SE, Rafique Z, Todd KH. Patient-reported Outcomes from A National, Prospective, Observational Study of Emergency Department Acute Pain Management With an Intranasal Nonsteroidal Anti-inflammatory Drug, Opioids, or Both. Acad Emerg Med. 2016 Mar;23(3):331-41. doi: 10.1111/acem.12902.</citation>
    <PMID>26782787</PMID>
  </reference>
  <reference>
    <citation>Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736. Erratum In: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.</citation>
    <PMID>19020154</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Louisville</investigator_affiliation>
    <investigator_full_name>Sean Francis, MD</investigator_full_name>
    <investigator_title>Chairperson &amp; Professor</investigator_title>
  </responsible_party>
  <keyword>Minimally Invasive Gynecologic Surgery</keyword>
  <keyword>Female Pelvic Reconstructive Surgery</keyword>
  <keyword>Post Operative Pain Control</keyword>
  <keyword>Narcotic Reduction</keyword>
  <keyword>Opioid Reduction</keyword>
  <keyword>Pelvic Organ Prolapse</keyword>
  <keyword>Stress Urinary Incontinence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</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/NCT04444830
org study id: 19.1351
nct id: NCT04444830
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The ongoing opioid epidemic has altered both how physicians prescribe narcotics and patients'
      perceptions of those prescriptions. Along with increased scrutiny regarding the quantity of
      opioids that be may prescribed after acute injury, for chronic conditions and following
      surgery the healthcare industry as a whole continues to search for alternative medications
      that provide adequate pain relief and have a reduced tendency for abuse/dependence/addition.
      To that end this study has the following aims:

        1. To evaluate the amount of opioids consumed following minimally invasive, female pelvic
           surgery when patients' postoperative pain is managed via:

             1. Acetaminophen plus Ibuprofen plus breakthrough pain opioids (Standard protocol)

             2. Acetaminophen plus Intranasal Ketorolac Tromethamine plus opioids for breakthrough
                pain (Sprix protocol)

        2. Patient satisfaction with the aforementioned methods

        3. Evaluate and compare pain scores via validated questionnaire

      Hypothesis:

      Primary:

      1. Patients prescribed intranasal Ketorolac (Sprix protocol) will consume significantly less
      Morphine Milliequivalents (mEqs) of narcotics compared to the standard protocol following
      minimally invasive female pelvic surgery.

      Secondary:

        1. Patients in the Sprix protocol will have lower Visual Analog Scale (VAS) measures of
           pain which will be measured on a 0-10 scale where 0 denotes no pain and 10 denotes
           maximum experience of pain

        2. Patients in the Sprix protocol will have lower numeric pain score and on POD#4

        3. Patients in the Sprix protocol will have higher Quality of Recovery 40 (QoR-40 )scores
           on POD#1

        4. Patients in the Sprix protocol will have higher QoR-40 scores on POD#4

        5. Patients will not have any significant difference in overall surgical satisfaction on
           POD#1 and POD#4 using a numerical satisfaction score

        6. Patients in the Sprix protocol will be more likely to consume no narcotics at all once
           discharged to home
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a multi-center, non-blinded, randomized control trial.
primary purpose: Treatment
masking: None (Open Label)
measure: Morphine mEqs
time frame: As measured from the day of surgery to 4 days post operative
description: The amount of narcotics consumed postoperatively as measure by Morphine milliequivalents
measure: Patient Satisfaction
time frame: Day of surgery to 4 days postoperative
description: Evaluate patient satisfaction using the validated QoR 40 (Quality of Recovery) Scale - wherein a minimum score of 40 indicates that a patient perceives there recovery to be very poor and a maximum score of 200 indicates that the patient perceives that the quality of their recovery is excellent
measure: Patient's perception of current pain
time frame: Day of surgery to 4 days postoperatively
description: The patient's pain will be subjectively scaled on a 0 (indicating no pain) to 10 (indicating maximum/severe pain) scale. The patient will be asked to scale their pain preoperatively, on postoperative day #1 and on Postoperative day #4
arm group label: Standard
arm group type: No Intervention
description: To compare the total amount of opioid consumption, as measured by morphine mEq, consumed in patients immediately postoperative from minimally invasive female pelvic reconstructive surgery - they will be prescribed a "standard" postoperative regimen of Acetaminophen 650 mg PO q 6-8 hours + Ibuprofen 600 mg PO q 6-8 hours + rescue narcotics (Oxycodone 5-10 mg PO q 4-6 hours or if allergic to Oxycodone, Norco 5-10mg/325mg PO q 4-6 hours) for breakthrough pain
arm group label: Sprix
arm group type: Experimental
description: To compare the total amount of opioid consumption, as measured by morphine mEq, consumed in patients immediately postoperative from minimally invasive female pelvic reconstructive surgery - they will be prescribed regimen of Sprix 30.5mg Intranasal q 6-8 hour up to 4 times daily + Acetaminophen 650 mg PO q 6- 8 hours + rescue narcotics (as above) for breakthrough pain during the day of surgery and the following 4 postoperative days.
intervention type: Drug
intervention name: Sprix
description: Intranasal Ketorolac - used as directed for an appropriate, previously established indication
arm group label: Sprix
other name: Intranasal Ketorolac
criteria: 
gender: Female
gender based: Yes
gender description: Female patients - all patients in the study are those that will undergo/have undergone female pelvic surgery (Urogynecology)
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Singla N, Singla S, Minkowitz HS, Moodie J, Brown C. Intranasal ketorolac for acute postoperative pain. Curr Med Res Opin. 2010 Aug;26(8):1915-23. doi: 10.1185/03007995.2010.495564. Erratum In: Curr Med Res Opin. 2012 Jun;28(6):1052.
PMID: 20557145
citation: Pergolizzi JV Jr, Taylor R Jr, Raffa RB. Intranasal ketorolac as part of a multimodal approach to postoperative pain. Pain Pract. 2015 Apr;15(4):378-88. doi: 10.1111/papr.12239. Epub 2014 Aug 28.
PMID: 25169467
citation: Pollack CV Jr, Diercks DB, Thomas SH, Shapiro NI, Fanikos J, Mace SE, Rafique Z, Todd KH. Patient-reported Outcomes from A National, Prospective, Observational Study of Emergency Department Acute Pain Management With an Intranasal Nonsteroidal Anti-inflammatory Drug, Opioids, or Both. Acad Emerg Med. 2016 Mar;23(3):331-41. doi: 10.1111/acem.12902.
PMID: 26782787
citation: Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736. Erratum In: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.
PMID: 19020154
responsible party type: Principal Investigator
investigator affiliation: University of Louisville
investigator full name: Sean Francis, MD
investigator title: Chairperson & Professor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Prolapse
mesh term: Pain, Postoperative
mesh term: Pelvic Organ Prolapse
mesh term: Ketorolac
sharing ipd: No