xml: <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/NCT05974423</url>
    </required_header>
    <id_info>
      <org_study_id>IRB 22-193</org_study_id>
      <nct_id>NCT05974423</nct_id>
    </id_info>
    <brief_title>Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation After Labrum Repair</brief_title>
    <official_title>Prospective Randomized Trial of Narcotic vs Non-Narcotic Pain Modulation Following a Labrum Repair</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Cooper Health System</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>New Jersey Health Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Cooper Health System</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to determine if patients age 15 to 30 years old being treated&#xD;
        for shoulder labrum repair and SLAP lesions have significant differences in pain levels&#xD;
        postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen&#xD;
        compared to oxycodone. Participants will be randomly placed into either the control arm and&#xD;
        receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the&#xD;
        experimental arm of the study. receiving only a prescription for the non-narcotic&#xD;
        medications. Every patient will receive a preoperative Exparel nerve block as is the standard&#xD;
        of care for this procedure. Both groups will fill out a pain journal for 14 days following&#xD;
        surgery and complete a pill count at the first postoperative visit to validate the amount of&#xD;
        pain medication documented in the pain journal.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The opioid crisis has illuminated the risks of opioid use for pain management, with renewed&#xD;
        interest in reducing opioid consumption after common orthopedic procedures. Anti-inflammatory&#xD;
        medication is an important component of multimodal pain management for patients undergoing&#xD;
        orthopedic surgery. Several relevant studies have inquired about the use of opioid&#xD;
        consumption in the management of total knee arthroplasty, total hip arthroplasty, total&#xD;
        shoulder arthroplasty as well as arthroscopic shoulder surgeries. There is currently a gap in&#xD;
        the literature, however, regarding the use of nerve blocks preoperatively in conjunction with&#xD;
        nonopioid pharmacology postoperatively for pain. The goal is to determine if this can reduce&#xD;
        pain levels in patients who have undergone surgical management for shoulder labrum or SLAP&#xD;
        lesions. Hopefully, the data we can extract will allow future physicians to decrease the&#xD;
        number of opioids prescribed and reduce the risks of prolonging the opioid epidemic.&#xD;
  &#xD;
        The United States is currently in an opioid crisis. This is a public health issue that not&#xD;
        only is limited to the United States but is echoed by countries around the world. All&#xD;
        physicians must be accountable for the continuation of the crisis but also must be cognizant&#xD;
        of ways to end the issue. In 2011, the United States Food and Drug Administration reported&#xD;
        that 50 million Americans were prescribed opioids which is close to a 100 percent increase in&#xD;
        the amount prescribed in 2008. Similarly, during that same period, opioid overdose became the&#xD;
        leading cause of accidental death in young adults; associated with a higher risk of&#xD;
        postoperative death, and increased risk of falls and fractures in the elderly. Many ways have&#xD;
        been discussed to reduce the prescription of opioids such as standardized opioid prescription&#xD;
        protocols, limits on prescription size, and restrictions on opioid use for preoperative and&#xD;
        nonsurgical patients. Another theater of opioid use that can be addressed is that of&#xD;
        post-operative pain management. The contribution of the potential results of our research&#xD;
        could greatly reduce and mitigate the number of opioids prescribed postoperatively if there&#xD;
        is no significant difference between the groups.&#xD;
  &#xD;
        This will be a prospective randomized trial. Patients will be randomly placed into either the&#xD;
        control or experimental arm of the study. Every patient will receive Exparel as is the&#xD;
        standard of care for this procedure.&#xD;
  &#xD;
        There will be two groups in this study:&#xD;
  &#xD;
          -  Group 1:&#xD;
  &#xD;
               1. Oxycodone 5 mg 1 tablet every 6 hours PRN&#xD;
  &#xD;
               2. Tylenol 1000 mg every 8 hours&#xD;
  &#xD;
               3. Ibuprofen 600 mg every 6 hours as needed for pain&#xD;
  &#xD;
          -  Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They&#xD;
             will be sent home with the following prescriptions. If this does not manage their pain,&#xD;
             they will call the resident on call who will reach out to the PI. The PI will then&#xD;
             electronically send in a prescription for oxycodone to their pharmacy if required. The&#xD;
             PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will&#xD;
             be sent home with these two prescriptions:&#xD;
  &#xD;
               1. Tylenol 1000 mg every 8 hours&#xD;
  &#xD;
               2. Ibuprofen 600 mg every 6 hours as needed for pain&#xD;
  &#xD;
        At the time of diagnosis and discussion of surgical intervention, patients will be asked if&#xD;
        they would like to participate in this research study. Patients will be considered screen&#xD;
        fails should they meet any exclusion criteria. They will be informed that depending on which&#xD;
        group they are randomly assigned to, they may have different prescriptions. Should the&#xD;
        patient be randomly assigned to the control group, they will be given the above medications.&#xD;
        Should the patient be randomly assigned to the experimental group, they will be given the&#xD;
        above medication scripts.&#xD;
  &#xD;
        To note, for shoulder surgeries, Cooper has been using Exparel as a nerve block agent as part&#xD;
        of the standard of care.&#xD;
  &#xD;
        Day 1 after surgery: both groups will begin completing their pain journal for 14 days. We&#xD;
        will allow two methods to complete the pain journal: REDCap or paper format. The REDCap&#xD;
        version will be emailed to patients daily so they can complete the questions. The paper&#xD;
        format will be available to all subjects regardless of if they complete the REDCap surveys.&#xD;
        This will be an extra measure to ensure all days are reported and there are no issues with&#xD;
        the REDCap.&#xD;
  &#xD;
        At 2 Weeks post-op: Patients' pain levels with be assessed in the immediate post-operative&#xD;
        period at their first follow-up visit with their respective attending physician.&#xD;
  &#xD;
        The subjects will keep track of pain levels through a pain journal which they fill out daily&#xD;
        and will bring to the first post-operative appointment. At their first post-operative visit,&#xD;
        patients will also bring their pill bottles for a pill count in the office to validate the&#xD;
        amount described in the pain journal.&#xD;
  &#xD;
        Both groups' subject's involvement will last 2 weeks post-operation. After this 2 week visit,&#xD;
        patients will have completed their course of the study.&#xD;
  &#xD;
        The current standard of practice at Cooper for orthopedic surgeons performing this procedure&#xD;
        is oxycodone 5mg PRN, ibuprofen 600mg every 6 hours, and acetaminophen 1000mg every 8 hours.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">December 16, 2022</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</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>Patients will be assigned to one of the following groups:&#xD;
  Group 1:&#xD;
  Oxycodone 5 mg 1 tablet every 6 hours PRN&#xD;
  Tylenol 1000 mg every 8 hours&#xD;
  Ibuprofen 600 mg every 6 hours as needed for pain&#xD;
  Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:&#xD;
  Tylenol 1000 mg every 8 hours&#xD;
  Ibuprofen 600 mg every 6 hours as needed for pain</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative pain control</measure>
      <time_frame>2 weeks</time_frame>
      <description>The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Postoperative Pain, Acute</condition>
    <condition>Opioid Use</condition>
    <condition>Labral Tear, Glenoid</condition>
    <arm_group>
      <arm_group_label>Control - Narcotic Prescription</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Oxycodone 5 mg 1 tablet every 6 hours PRN&#xD;
  Tylenol 1000 mg every 8 hours&#xD;
  Ibuprofen 600 mg every 6 hours as needed for pain</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental - Non-narcotic only</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:&#xD;
  Tylenol 1000 mg every 8 hours&#xD;
  Ibuprofen 600 mg every 6 hours as needed for pain</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tylenol, Ibuprofen, and Oxycodone</intervention_name>
      <description>A script for these three medications will be provided</description>
      <arm_group_label>Control - Narcotic Prescription</arm_group_label>
      <other_name>Both Narcotic and Non-narcotic</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tylenol and Ibuprofen only</intervention_name>
      <description>A script for only these two medications will be provided initially following surgery. Should the patient need stronger medication for adequate pain control, the on-call physician will provide a script for oxycodone</description>
      <arm_group_label>Experimental - Non-narcotic only</arm_group_label>
      <other_name>Non-narcotic only</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients between the ages of 15 - 25 years old&#xD;
  &#xD;
            -  Patients with a diagnosis of a labrum tear who will undergo surgical intervention&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under the age of 14 years old&#xD;
  &#xD;
            -  Patients age 26 years or older&#xD;
  &#xD;
            -  Patients with a nonoperative diagnosis of a labrum tear&#xD;
  &#xD;
            -  Patients who elect not to undergo surgical treatment&#xD;
  &#xD;
            -  Patients who are on opioid medications preoperatively&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Catherine J Fedorka, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cooper Hospital Orthopedic Surgery</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Cooper University Hospital</name>
        <address>
          <city>Camden</city>
          <state>New Jersey</state>
          <zip>08103</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Familiari F, Huri G, Simonetta R, McFarland EG. SLAP lesions: current controversies. EFORT Open Rev. 2019 Jan 28;4(1):25-32. doi: 10.1302/2058-5241.4.180033. eCollection 2019 Jan.</citation>
      <PMID>30800477</PMID>
    </reference>
    <reference>
      <citation>Hester WA, O'Brien MJ, Heard WMR, Savoie FH. Current Concepts in the Evaluation and Management of Type II Superior Labral Lesions of the Shoulder. Open Orthop J. 2018 Jul 31;12:331-341. doi: 10.2174/1874325001812010331. eCollection 2018.</citation>
      <PMID>30197715</PMID>
    </reference>
    <reference>
      <citation>Jain A, Aniq H, Mistry A. SLAP Injury and the Superior Labrum. Semin Musculoskelet Radiol. 2022 Oct;26(5):577-584. doi: 10.1055/s-0042-1758840. Epub 2022 Dec 19.</citation>
      <PMID>36535593</PMID>
    </reference>
    <reference>
      <citation>Matsuki K, Sugaya H. Complications after arthroscopic labral repair for shoulder instability. Curr Rev Musculoskelet Med. 2015 Mar;8(1):53-58. doi: 10.1007/s12178-014-9248-5.</citation>
      <PMID>25532917</PMID>
    </reference>
    <reference>
      <citation>Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.</citation>
      <PMID>34196965</PMID>
    </reference>
    <reference>
      <citation>O'Neill A, Lirk P. Multimodal Analgesia. Anesthesiol Clin. 2022 Sep;40(3):455-468. doi: 10.1016/j.anclin.2022.04.002. Epub 2022 Aug 2.</citation>
      <PMID>36049874</PMID>
    </reference>
    <reference>
      <citation>Elmallah RK, Chughtai M, Khlopas A, Newman JM, Stearns KL, Roche M, Kelly MA, Harwin SF, Mont MA. Pain Control in Total Knee Arthroplasty. J Knee Surg. 2018 Jul;31(6):504-513. doi: 10.1055/s-0037-1604152. Epub 2017 Jul 18.</citation>
      <PMID>28719941</PMID>
    </reference>
    <reference>
      <citation>Dada O, Gonzalez Zacarias A, Ongaigui C, Echeverria-Villalobos M, Kushelev M, Bergese SD, Moran K. Does Rebound Pain after Peripheral Nerve Block for Orthopedic Surgery Impact Postoperative Analgesia and Opioid Consumption? A Narrative Review. Int J Environ Res Public Health. 2019 Sep 5;16(18):3257. doi: 10.3390/ijerph16183257.</citation>
      <PMID>31491863</PMID>
    </reference>
    <reference>
      <citation>Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2.</citation>
      <PMID>27558150</PMID>
    </reference>
    <reference>
      <citation>Kaye AD, Novitch MB, Carlson SF, Fuller MC, White SW, Haroldson AR, Kaiser JA, Elkersh MA, Brunk AJ, Jeha GM, Cornett EM. The Role of Exparel Plus Meloxicam for Postoperative Pain Management. Curr Pain Headache Rep. 2020 Jan 30;24(3):6. doi: 10.1007/s11916-020-0837-2.</citation>
      <PMID>32002676</PMID>
    </reference>
    <reference>
      <citation>Blair HA. Bupivacaine/Meloxicam Prolonged Release: A Review in Postoperative Pain. Drugs. 2021 Jul;81(10):1203-1211. doi: 10.1007/s40265-021-01551-9. Epub 2021 Jul 6.</citation>
      <PMID>34228280</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Labrum repair</keyword>
    <keyword>opioid consumption</keyword>
    <keyword>postoperative pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acetaminophen</mesh_term>
      <mesh_term>Ibuprofen</mesh_term>
      <mesh_term>Oxycodone</mesh_term>
      <mesh_term>Narcotics</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974423
  org study id: IRB 22-193
  nct id: NCT05974423
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to determine if patients age 15 to 30 years old being treated
        for shoulder labrum repair and SLAP lesions have significant differences in pain levels
        postoperatively when treated with a combination therapy of ibuprofen, and acetaminophen
        compared to oxycodone. Participants will be randomly placed into either the control arm and
        receive scripts for non-narcotic medications (Tylenol and Ibuprofen) and opioids, or the
        experimental arm of the study. receiving only a prescription for the non-narcotic
        medications. Every patient will receive a preoperative Exparel nerve block as is the standard
        of care for this procedure. Both groups will fill out a pain journal for 14 days following
        surgery and complete a pill count at the first postoperative visit to validate the amount of
        pain medication documented in the pain journal.
  The opioid crisis has illuminated the risks of opioid use for pain management, with renewed
        interest in reducing opioid consumption after common orthopedic procedures. Anti-inflammatory
        medication is an important component of multimodal pain management for patients undergoing
        orthopedic surgery. Several relevant studies have inquired about the use of opioid
        consumption in the management of total knee arthroplasty, total hip arthroplasty, total
        shoulder arthroplasty as well as arthroscopic shoulder surgeries. There is currently a gap in
        the literature, however, regarding the use of nerve blocks preoperatively in conjunction with
        nonopioid pharmacology postoperatively for pain. The goal is to determine if this can reduce
        pain levels in patients who have undergone surgical management for shoulder labrum or SLAP
        lesions. Hopefully, the data we can extract will allow future physicians to decrease the
        number of opioids prescribed and reduce the risks of prolonging the opioid epidemic.
  
        The United States is currently in an opioid crisis. This is a public health issue that not
        only is limited to the United States but is echoed by countries around the world. All
        physicians must be accountable for the continuation of the crisis but also must be cognizant
        of ways to end the issue. In 2011, the United States Food and Drug Administration reported
        that 50 million Americans were prescribed opioids which is close to a 100 percent increase in
        the amount prescribed in 2008. Similarly, during that same period, opioid overdose became the
        leading cause of accidental death in young adults; associated with a higher risk of
        postoperative death, and increased risk of falls and fractures in the elderly. Many ways have
        been discussed to reduce the prescription of opioids such as standardized opioid prescription
        protocols, limits on prescription size, and restrictions on opioid use for preoperative and
        nonsurgical patients. Another theater of opioid use that can be addressed is that of
        post-operative pain management. The contribution of the potential results of our research
        could greatly reduce and mitigate the number of opioids prescribed postoperatively if there
        is no significant difference between the groups.
  
        This will be a prospective randomized trial. Patients will be randomly placed into either the
        control or experimental arm of the study. Every patient will receive Exparel as is the
        standard of care for this procedure.
  
        There will be two groups in this study:
  
          -  Group 1:
  
               1. Oxycodone 5 mg 1 tablet every 6 hours PRN
  
               2. Tylenol 1000 mg every 8 hours
  
               3. Ibuprofen 600 mg every 6 hours as needed for pain
  
          -  Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They
             will be sent home with the following prescriptions. If this does not manage their pain,
             they will call the resident on call who will reach out to the PI. The PI will then
             electronically send in a prescription for oxycodone to their pharmacy if required. The
             PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will
             be sent home with these two prescriptions:
  
               1. Tylenol 1000 mg every 8 hours
  
               2. Ibuprofen 600 mg every 6 hours as needed for pain
  
        At the time of diagnosis and discussion of surgical intervention, patients will be asked if
        they would like to participate in this research study. Patients will be considered screen
        fails should they meet any exclusion criteria. They will be informed that depending on which
        group they are randomly assigned to, they may have different prescriptions. Should the
        patient be randomly assigned to the control group, they will be given the above medications.
        Should the patient be randomly assigned to the experimental group, they will be given the
        above medication scripts.
  
        To note, for shoulder surgeries, Cooper has been using Exparel as a nerve block agent as part
        of the standard of care.
  
        Day 1 after surgery: both groups will begin completing their pain journal for 14 days. We
        will allow two methods to complete the pain journal: REDCap or paper format. The REDCap
        version will be emailed to patients daily so they can complete the questions. The paper
        format will be available to all subjects regardless of if they complete the REDCap surveys.
        This will be an extra measure to ensure all days are reported and there are no issues with
        the REDCap.
  
        At 2 Weeks post-op: Patients' pain levels with be assessed in the immediate post-operative
        period at their first follow-up visit with their respective attending physician.
  
        The subjects will keep track of pain levels through a pain journal which they fill out daily
        and will bring to the first post-operative appointment. At their first post-operative visit,
        patients will also bring their pill bottles for a pill count in the office to validate the
        amount described in the pain journal.
  
        Both groups' subject's involvement will last 2 weeks post-operation. After this 2 week visit,
        patients will have completed their course of the study.
  
        The current standard of practice at Cooper for orthopedic surgeons performing this procedure
        is oxycodone 5mg PRN, ibuprofen 600mg every 6 hours, and acetaminophen 1000mg every 8 hours.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be assigned to one of the following groups:
  Group 1:
  Oxycodone 5 mg 1 tablet every 6 hours PRN
  Tylenol 1000 mg every 8 hours
  Ibuprofen 600 mg every 6 hours as needed for pain
  Group 2 (Experimental Group) will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:
  Tylenol 1000 mg every 8 hours
  Ibuprofen 600 mg every 6 hours as needed for pain
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Postoperative pain control
  time frame: 2 weeks
  description: The subjects will keep track of pain levels through a pain journal which they fill out daily and will bring to the first post-operative appointment. At their first post-operative visit, patients will also bring their pill bottles for a pill count in the office to validate the amount described in the pain journal.
  arm group label: Control - Narcotic Prescription
  arm group type: Active Comparator
  description: Oxycodone 5 mg 1 tablet every 6 hours PRN
  Tylenol 1000 mg every 8 hours
  Ibuprofen 600 mg every 6 hours as needed for pain
  arm group label: Experimental - Non-narcotic only
  arm group type: Experimental
  description: This group will not be sent home with an oxycodone prescription. They will be sent home with the following prescriptions. If this does not manage their pain, they will call the resident on call who will reach out to the PI. The PI will then electronically send in a prescription of oxycodone to their pharmacy if required. The PI or operating surgeon (co-investigators) will be available 24/7 to do this. They will be sent home with these two prescriptions:
  Tylenol 1000 mg every 8 hours
  Ibuprofen 600 mg every 6 hours as needed for pain
  intervention type: Drug
  intervention name: Tylenol, Ibuprofen, and Oxycodone
  description: A script for these three medications will be provided
  arm group label: Control - Narcotic Prescription
  other name: Both Narcotic and Non-narcotic
  intervention type: Drug
  intervention name: Tylenol and Ibuprofen only
  description: A script for only these two medications will be provided initially following surgery. Should the patient need stronger medication for adequate pain control, the on-call physician will provide a script for oxycodone
  arm group label: Experimental - Non-narcotic only
  other name: Non-narcotic only
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Catherine J Fedorka, MD
  role: Principal Investigator
  affiliation: Cooper Hospital Orthopedic Surgery
  facility: 
  country: United States
  citation: Familiari F, Huri G, Simonetta R, McFarland EG. SLAP lesions: current controversies. EFORT Open Rev. 2019 Jan 28;4(1):25-32. doi: 10.1302/2058-5241.4.180033. eCollection 2019 Jan.
  PMID: 30800477
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  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Acute Pain
  mesh term: Rotator Cuff Injuries
  mesh term: Acetaminophen
  mesh term: Ibuprofen
  mesh term: Oxycodone
  mesh term: Narcotics