<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/NCT03825809</url>
  </required_header>
  <id_info>
    <org_study_id>1231914</org_study_id>
    <nct_id>NCT03825809</nct_id>
  </id_info>
  <brief_title>Nonopioid Analgesia After Labral Surgery</brief_title>
  <official_title>Traditional vs. Nonopioid Analgesia After Labral Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</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>
      This is a randomized, single blinded, standard of care controlled clinical trial. This&#xD;
      project aims to compare postoperative pain control in patients in two treatment arms of&#xD;
      rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard&#xD;
      of care control group given standard opioid pain control regimen&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: This is a randomized, single blinded, standard of care-controlled clinical&#xD;
      trial. All adult patients over eighteen desiring rotator cuff repair will be eligible.&#xD;
      Nonnarcotic postoperative pain control regimen described below were chosen based on previous&#xD;
      studies in fracture care and joint arthroplasty.&#xD;
&#xD;
      Patients will be consented and recruited. Once participation has been determined and consent&#xD;
      obtained, the names of participating patients will be provided to the research pharmacy.&#xD;
      Patients will be randomized with a computer-generated table in 2 patient blocks by the&#xD;
      research pharmacy. Patients postoperative analgesia will be divided into one of the following&#xD;
      2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain&#xD;
      analgesia&#xD;
&#xD;
      Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be&#xD;
      collected at each post-operative day using a journal. Moreover, endpoints will be collected&#xD;
      at the patient's first post-operative appointment. These appointments are scheduled within&#xD;
      one-week of the index procedure.&#xD;
&#xD;
      Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests&#xD;
      and reported as means ± standard deviations. Categorical data will be compared between the 2&#xD;
      groups using chi-square tests and reported as counts and percentages. A preliminary test to&#xD;
      confirm the quality of variances will be conducted prior to utilizing the t test to confirm&#xD;
      the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher&#xD;
      exact tests will be used as needed for nonnormal distributions and low variable numbers,&#xD;
      respectively. A multivariable regression analysis was performed to assess for potential&#xD;
      confounding demographic variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">May 20, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 20, 2020</primary_completion_date>
  <phase>Phase 2/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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Levels</measure>
    <time_frame>10 days post-operatively</time_frame>
    <description>Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System</measure>
    <time_frame>10 days post-operatively</time_frame>
    <description>Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Narcotic Use</condition>
  <arm_group>
    <arm_group_label>Post-Operative Non Opioid Pain Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be administered a post-operative non-opioid pain protocol consisting of:&#xD;
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Operative Traditional Pain Protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>Post-Operative Non Opioid Pain Protocol</description>
    <arm_group_label>Post-Operative Non Opioid Pain Protocol</arm_group_label>
    <other_name>Celebrex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydrocodone-Acetaminophen</intervention_name>
    <description>Traditionally used narcotic pain protocol</description>
    <arm_group_label>Post-Operative Traditional Pain Protocol</arm_group_label>
    <other_name>Norco</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>Post-Operative Non Opioid Pain Protocol</description>
    <arm_group_label>Post-Operative Non Opioid Pain Protocol</arm_group_label>
    <other_name>Toradol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gabapentin</intervention_name>
    <description>Post-Operative Non Opioid Pain Protocol</description>
    <arm_group_label>Post-Operative Non Opioid Pain Protocol</arm_group_label>
    <other_name>Neurontin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>Post-Operative Non Opioid Pain Protocol</description>
    <arm_group_label>Post-Operative Non Opioid Pain Protocol</arm_group_label>
    <other_name>Tylenol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Diazepam</intervention_name>
    <description>Post-Operative Non Opioid Pain Protocol</description>
    <arm_group_label>Post-Operative Non Opioid Pain Protocol</arm_group_label>
    <other_name>Valium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients over age 18 and scheduled for a primary or revision labral surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria will include patients with a medical history of known allergies or&#xD;
             intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin,&#xD;
             dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of&#xD;
             narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI&#xD;
             bleeding. Secondary exclusion criterion is an intact rotator cuff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Toufic R Jildeh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henry Ford Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Toufic R Jildeh, MD</last_name>
    <phone>517-230-8511</phone>
    <email>tjildeh1@hfhs.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Toufic R Jildeh, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>Toufic R. Jildeh</investigator_full_name>
    <investigator_title>Resident Investigator</investigator_title>
  </responsible_party>
  <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>Ketorolac</mesh_term>
    <mesh_term>Acetaminophen, hydrocodone drug combination</mesh_term>
    <mesh_term>Diazepam</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Hydrocodone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Per request</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>January 27, 2022</submitted>
    <returned>February 16, 2022</returned>
  </pending_results>
  <!-- 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/NCT03825809
org study id: 1231914
nct id: NCT03825809
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a randomized, single blinded, standard of care controlled clinical trial. This
      project aims to compare postoperative pain control in patients in two treatment arms of
      rotator cuff repair: a treatment group given a nonopioid pain control regimen, and a standard
      of care control group given standard opioid pain control regimen
Study Design: This is a randomized, single blinded, standard of care-controlled clinical
      trial. All adult patients over eighteen desiring rotator cuff repair will be eligible.
      Nonnarcotic postoperative pain control regimen described below were chosen based on previous
      studies in fracture care and joint arthroplasty.

      Patients will be consented and recruited. Once participation has been determined and consent
      obtained, the names of participating patients will be provided to the research pharmacy.
      Patients will be randomized with a computer-generated table in 2 patient blocks by the
      research pharmacy. Patients postoperative analgesia will be divided into one of the following
      2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain
      analgesia

      Primary endpoints is reduction in pain as measured by VAS and PROMIS. The endpoints will be
      collected at each post-operative day using a journal. Moreover, endpoints will be collected
      at the patient's first post-operative appointment. These appointments are scheduled within
      one-week of the index procedure.

      Statistical Analysis: All continuous data will be analyzed using independent 2-group t tests
      and reported as means ± standard deviations. Categorical data will be compared between the 2
      groups using chi-square tests and reported as counts and percentages. A preliminary test to
      confirm the quality of variances will be conducted prior to utilizing the t test to confirm
      the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher
      exact tests will be used as needed for nonnormal distributions and low variable numbers,
      respectively. A multivariable regression analysis was performed to assess for potential
      confounding demographic variables.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Pain Levels
time frame: 10 days post-operatively
description: Patients recorded pain levels 3 times per day using Visual analog scales until study completion. Average daily pain was calculated for each patient. Higher values portend worse control.
measure: Patient-Reported Outcomes Measurement Information System
time frame: 10 days post-operatively
description: Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) nightly until study completion. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.
arm group label: Post-Operative Non Opioid Pain Protocol
arm group type: Experimental
description: Patients will be administered a post-operative non-opioid pain protocol consisting of:
Celecoxib Ketorolac Gabapentin Acetaminophen Diazepam
arm group label: Post-Operative Traditional Pain Protocol
arm group type: Active Comparator
description: Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen 5-325
intervention type: Drug
intervention name: Celecoxib
description: Post-Operative Non Opioid Pain Protocol
arm group label: Post-Operative Non Opioid Pain Protocol
other name: Celebrex
intervention type: Drug
intervention name: Hydrocodone-Acetaminophen
description: Traditionally used narcotic pain protocol
arm group label: Post-Operative Traditional Pain Protocol
other name: Norco
intervention type: Drug
intervention name: Ketorolac
description: Post-Operative Non Opioid Pain Protocol
arm group label: Post-Operative Non Opioid Pain Protocol
other name: Toradol
intervention type: Drug
intervention name: Gabapentin
description: Post-Operative Non Opioid Pain Protocol
arm group label: Post-Operative Non Opioid Pain Protocol
other name: Neurontin
intervention type: Drug
intervention name: Acetaminophen
description: Post-Operative Non Opioid Pain Protocol
arm group label: Post-Operative Non Opioid Pain Protocol
other name: Tylenol
intervention type: Drug
intervention name: Diazepam
description: Post-Operative Non Opioid Pain Protocol
arm group label: Post-Operative Non Opioid Pain Protocol
other name: Valium
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Toufic R Jildeh, MD
role: Principal Investigator
affiliation: Henry Ford Health System
last name: Toufic R Jildeh, MD
phone: 517-230-8511
email: tjildeh1@hfhs.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Toufic R. Jildeh
investigator title: Resident Investigator
mesh term: Acetaminophen
mesh term: Celecoxib
mesh term: Ketorolac
mesh term: Acetaminophen, hydrocodone drug combination
mesh term: Diazepam
mesh term: Gabapentin
mesh term: Hydrocodone
sharing ipd: Undecided
ipd description: Per request
submitted: January 27, 2022
returned: February 16, 2022