<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/NCT03021096</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0779</org_study_id>
    <nct_id>NCT03021096</nct_id>
  </id_info>
  <brief_title>Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia</brief_title>
  <acronym>TSA Pain</acronym>
  <official_title>Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to identify the timeline of pain following total shoulder replacement with&#xD;
      the goal of developing data for a subsequent randomized trial. The investigators believe that&#xD;
      with using HSS's current protocol, many patients have postoperative pain that is no worse&#xD;
      than their preoperative pain. Previous HSS anesthesia protocols for total shoulder&#xD;
      arthroplasty patients have not formally followed patients past their hospital discharge, and&#xD;
      the investigators believe that some patients do experience moderate to severe subacute&#xD;
      postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain&#xD;
      scores at 14 days after surgery. Future studies will look at measures of preventing bruising&#xD;
      and subsequent pain after shoulder replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot study, with the goals of&#xD;
&#xD;
        1. developing data for a subsequent randomized trials&#xD;
&#xD;
        2. describing the pain trajectory after total shoulder arthroplasty given comprehensive&#xD;
           multimodal perioperative analgesia&#xD;
&#xD;
        3. gathering preliminary data about which shoulder arthroplasty patients are at high risk&#xD;
           for moderate or severe postoperative pain (NRS with movement, POD14, moderate &gt;= 4- 6;&#xD;
           Gerbershagen 2011; severe &gt;= 7-10, Krebs 2007) Potential factors include fibromyalgia&#xD;
           score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use&#xD;
&#xD;
        4. gathering preliminary data on the potential association between the predictors listed in&#xD;
           (c) and NRS pain score with movement on POD 14.&#xD;
&#xD;
        5. estimating incidence and severity of postoperative bruising on POD 14&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Actual">March 22, 2018</completion_date>
  <primary_completion_date type="Actual">December 18, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NRS Pain Scores</measure>
    <time_frame>14 days after surgery for each patient</time_frame>
    <description>Quantifying patients' pain at a sub-acute time point after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NRS pain with movement and at rest</measure>
    <time_frame>Days 1, 3, 7 and 3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid and NSAID consumption (in past 24 hours)</measure>
    <time_frame>Days 1, 3, 7 and 3 months after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of analgesic pills taken</measure>
    <time_frame>1 day, 3 days, 7 days, 14 days and 3 months after surgery</time_frame>
    <description>Other analgesic usage - POD1, POD3, POD7, POD 14, 3 months. (Number of tablets of other analgesics used in past 24 hours, including acetaminophen, NSAIDs, COX2 inhibitors, gabapentin, pregabalin, muscle relaxants)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Related Symptom Distress Scale</measure>
    <time_frame>Day 1 after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of Motion</measure>
    <time_frame>Day 14 after surgery and 3 months after surgery</time_frame>
    <description>Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and Severity of Bruising</measure>
    <time_frame>Day 14 after surgery and 3 months after surgery</time_frame>
    <description>Surgeon will determine whether bruising occurred and if so, the size and severity of the bruise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>Day 1 after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PainOUT Questionnaire</measure>
    <time_frame>Day 1 and 14 after surgery</time_frame>
    <description>Included satisfaction question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain catastrophizing Scale</measure>
    <time_frame>Day of Surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fibromyalgia Scale</measure>
    <time_frame>Day of Surgery</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">108</enrollment>
  <condition>TSA</condition>
  <condition>Bruise</condition>
  <condition>Pain, Postoperative</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surveys</intervention_name>
    <description>The study is just using validated surveys to assess pain and mood states after surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing TSA for Osteoarthritis, Reverse, Anatomic procedures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients eligible for the standardized anesthetic for TSA&#xD;
&#xD;
          -  Patients who are capable to provide informed consent and answer questions in English&#xD;
             (Study involves questionnaires validated in English)&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incapable to provide informed consent&#xD;
&#xD;
          -  Contraindications for regional anesthesia (anticoagulation, infection at injection&#xD;
             site)&#xD;
&#xD;
          -  Patients undergoing TSA for Trauma or Rheumatoid Arthritis&#xD;
&#xD;
          -  Revision TSA (previous non-TSA surgery is not an exclusion)&#xD;
&#xD;
          -  Conversion of hemiarthroplasty to TSA&#xD;
&#xD;
          -  Planned use of tranexamic acid&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques YaDeau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Goon AK, Dines DM, Craig EV, Gordon MA, Goytizolo EA, Lin Y, Lin E, YaDeau JT. A clinical pathway for total shoulder arthroplasty-a pilot study. HSS J. 2014 Jul;10(2):100-6. doi: 10.1007/s11420-014-9381-0. Epub 2014 Mar 8.</citation>
    <PMID>25050091</PMID>
  </reference>
  <reference>
    <citation>YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14.</citation>
    <PMID>26814246</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>April 19, 2022</submitted>
    <returned>January 20, 2023</returned>
    <submitted>February 9, 2023</submitted>
  </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/NCT03021096
org study id: 2016-0779
nct id: NCT03021096
lead sponsor: 
has dmc: Yes
This study aims to identify the timeline of pain following total shoulder replacement with
      the goal of developing data for a subsequent randomized trial. The investigators believe that
      with using HSS's current protocol, many patients have postoperative pain that is no worse
      than their preoperative pain. Previous HSS anesthesia protocols for total shoulder
      arthroplasty patients have not formally followed patients past their hospital discharge, and
      the investigators believe that some patients do experience moderate to severe subacute
      postoperative pain. Therefore, this study's primary outcome is to look at the numeric pain
      scores at 14 days after surgery. Future studies will look at measures of preventing bruising
      and subsequent pain after shoulder replacement.
This is a pilot study, with the goals of

        1. developing data for a subsequent randomized trials

        2. describing the pain trajectory after total shoulder arthroplasty given comprehensive
           multimodal perioperative analgesia

        3. gathering preliminary data about which shoulder arthroplasty patients are at high risk
           for moderate or severe postoperative pain (NRS with movement, POD14, moderate >= 4- 6;
           Gerbershagen 2011; severe >= 7-10, Krebs 2007) Potential factors include fibromyalgia
           score, catastrophizing score, anxiety/depression score, gender, preoperative opioid use

        4. gathering preliminary data on the potential association between the predictors listed in
           (c) and NRS pain score with movement on POD 14.

        5. estimating incidence and severity of postoperative bruising on POD 14
observational model: Cohort
time perspective: Prospective
measure: NRS Pain Scores
time frame: 14 days after surgery for each patient
description: Quantifying patients' pain at a sub-acute time point after surgery
measure: NRS pain with movement and at rest
time frame: Days 1, 3, 7 and 3 months after surgery
measure: Opioid and NSAID consumption (in past 24 hours)
time frame: Days 1, 3, 7 and 3 months after surgery
measure: Total number of analgesic pills taken
time frame: 1 day, 3 days, 7 days, 14 days and 3 months after surgery
description: Other analgesic usage - POD1, POD3, POD7, POD 14, 3 months. (Number of tablets of other analgesics used in past 24 hours, including acetaminophen, NSAIDs, COX2 inhibitors, gabapentin, pregabalin, muscle relaxants)
measure: Opioid Related Symptom Distress Scale
time frame: Day 1 after surgery
measure: Range of Motion
time frame: Day 14 after surgery and 3 months after surgery
description: Measure the ability of shoulder movement from 0 to 180 degrees at these follow up visits with the surgeon after surgery.
measure: Incidence and Severity of Bruising
time frame: Day 14 after surgery and 3 months after surgery
description: Surgeon will determine whether bruising occurred and if so, the size and severity of the bruise
measure: Hospital Anxiety and Depression Scale
time frame: Day 1 after surgery
measure: PainOUT Questionnaire
time frame: Day 1 and 14 after surgery
description: Included satisfaction question
measure: Pain catastrophizing Scale
time frame: Day of Surgery
measure: Fibromyalgia Scale
time frame: Day of Surgery
intervention type: Other
intervention name: Surveys
description: The study is just using validated surveys to assess pain and mood states after surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacques YaDeau, MD, PhD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
citation: Goon AK, Dines DM, Craig EV, Gordon MA, Goytizolo EA, Lin Y, Lin E, YaDeau JT. A clinical pathway for total shoulder arthroplasty-a pilot study. HSS J. 2014 Jul;10(2):100-6. doi: 10.1007/s11420-014-9381-0. Epub 2014 Mar 8.
PMID: 25050091
citation: YaDeau JT, Gordon MA, Goytizolo EA, Lin Y, Fields KG, Goon AK, Holck G, Miu TW, Gulotta LV, Dines DM, Craig EV. Buprenorphine, Clonidine, Dexamethasone, and Ropivacaine for Interscalene Nerve Blockade: A Prospective, Randomized, Blinded, Ropivacaine Dose-Response Study. Pain Med. 2016 May;17(5):940-60. doi: 10.1093/pm/pnv010. Epub 2015 Dec 14.
PMID: 26814246
responsible party type: Sponsor
mesh term: Pain, Postoperative
submitted: April 19, 2022
returned: January 20, 2023
submitted: February 9, 2023