<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/NCT03820193</url>
  </required_header>
  <id_info>
    <org_study_id>123193</org_study_id>
    <nct_id>NCT03820193</nct_id>
  </id_info>
  <brief_title>Nonopioid Analgesia After Arthroscopic Meniscus Surgery</brief_title>
  <official_title>Traditional vs. Nonopioid Analgesia After Arthroscopic Meniscus 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>
  </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;
      arthroscopic meniscus surgery: a treatment group given a non-opioid pain control regimen, and&#xD;
      a standard 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 arthroscopic meniscus surgery will be&#xD;
      eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on&#xD;
      previous 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 Visual Analog Score and Patient&#xD;
      Reported Outcome Measurement Informatics Systems. The endpoints will be collected at each&#xD;
      post-operative day using a journal. Moreover, endpoints will be collected at the patient's&#xD;
      first post-operative appointment. These appointments are scheduled within one-week of the&#xD;
      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>Completed</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">January 20, 2021</completion_date>
  <primary_completion_date type="Actual">June 20, 2020</primary_completion_date>
  <phase>Early Phase 1</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 record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. Average daily pain was calculated for each patient. Higher values portend worse control.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Reported Outcome Measurement Information System</measure>
    <time_frame>10 days post-operatively</time_frame>
    <description>Patient Reported Outcome Measurement Information System - Pain Interference (PROMIS PI) scores collected 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="Actual">61</enrollment>
  <condition>Meniscus Disorder</condition>
  <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: 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</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>Hydrocodon/Acetaminophen</intervention_name>
    <description>Traditionally used narcotic pain control</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>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients over age 18 scheduled for arthroscopic meniscus repair or partial&#xD;
             menisectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a medical history of known allergies or intolerance to allergies or&#xD;
             intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial&#xD;
             alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery,&#xD;
             renal impairment, peptic ulcer disease, GI bleeding.&#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>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 26, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>February 10, 2021</last_update_submitted>
  <last_update_submitted_qc>February 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2021</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_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>
  <!-- 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/NCT03820193
org study id: 123193
nct id: NCT03820193
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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
      arthroscopic meniscus surgery: a treatment group given a non-opioid 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 arthroscopic meniscus surgery 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 Visual Analog Score and Patient
      Reported Outcome Measurement Informatics Systems. 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 record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. Average daily pain was calculated for each patient. Higher values portend worse control.
measure: Patient Reported Outcome Measurement Information System
time frame: 10 days post-operatively
description: Patient Reported Outcome Measurement Information System - Pain Interference (PROMIS PI) scores collected 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
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: Hydrocodon/Acetaminophen
description: Traditionally used narcotic pain control
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
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: Toufic R. Jildeh
investigator title: Resident
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