<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/NCT04421196</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00254474</org_study_id>
    <nct_id>NCT04421196</nct_id>
  </id_info>
  <brief_title>Opioid-free Total Hip Arthroplasty</brief_title>
  <official_title>Opioid-free Total Hip Arthroplasty: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of investigators' proposed study is to demonstrate that the following&#xD;
      two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS)&#xD;
      scores up to 3 months post-operatively: one that is administered a modified multimodal&#xD;
      analgesic pathway without opioids and the other administered the current standard multimodal&#xD;
      analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The&#xD;
      secondary objective is to demonstrate that these cohorts will also have equivalent functional&#xD;
      outcomes as determined by both objective measures (such as hip range of motion) and&#xD;
      patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome&#xD;
      Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Currently does not have active IRB status.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 15, 2022</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
  <phase>N/A</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>Randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores</measure>
    <time_frame>From immediate post-operative period to 3 months post-operatively</time_frame>
    <description>Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)</measure>
    <time_frame>From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively</time_frame>
    <description>A patient-reported measure that assesses components such as assesses patient pain, satisfaction including stiffness and range of motion, activity limitations-daily living, sports and recreation function, and quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale</measure>
    <time_frame>From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively</time_frame>
    <description>The UCLA scale is a patient-reported measure ranging from 1 to 10. Patients indicate their most appropriate activity level, with 1 defined as &quot;no physical activity, dependent on others&quot; and 10 defined as &quot;regular participation in impact sports.&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hip Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Standard multimodal analgesic pathway with opioids</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is the control group, who will receive the current standard multimodal analgesic regimen, which includes opioids following total hip arthroplasty at Johns Hopkins Bayview Hospital.&#xD;
The current standard multimodal analgesic regimen utilizes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Opioid (fentanyl) &amp; Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: 0.25 % bupivacaine with epinephrine and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Oxycodone 5-10 mg PO, IV opioids (Morphine, hydromorphone), Acetaminophen 1000 mg PO q6hr</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified multimodal analgesic pathway without opioids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the experimental group, who will receive a modified multimodal analgesic regimen, which excludes the use of any opioids.&#xD;
The modified multimodal analgesic regimen utilizes the following medications:&#xD;
includes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: Liposomal bupivacaine, 0.25 % bupivacaine with epinephrine, Betamethasone sodium phosphate, betamethasone acetate and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Ketamine IV, Ketorolac 15 mg PO, Acetaminophen 1000 mg PO q6hr</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exclusion of opioid analgesics</intervention_name>
    <description>The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.</description>
    <arm_group_label>Modified multimodal analgesic pathway without opioids</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of all ages with end-stage primary hip osteoarthritis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with creatinine clearance between 30 and 60 mL/min&#xD;
&#xD;
          -  Use of any opioid analgesics in the 6 months preceding surgery&#xD;
&#xD;
          -  Revision total hip arthroplasty&#xD;
&#xD;
          -  Patients with liver insufficiency&#xD;
&#xD;
          -  Patients on chronic anticoagulation&#xD;
&#xD;
          -  Workers compensation patients&#xD;
&#xD;
          -  Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any&#xD;
             reason (e.g. allergies)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julius Oni, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <reference>
    <citation>Madras BK. The President's Commission on Combating Drug Addiction and the Opioid Crisis: Origins and Recommendations. Clin Pharmacol Ther. 2018 Jun;103(6):943-945. doi: 10.1002/cpt.1050. Epub 2018 Mar 23.</citation>
    <PMID>29570781</PMID>
  </reference>
  <reference>
    <citation>Rodriguez-Merchan EC, Vaquero-Picado A, Ruiz-Perez JS. Correction to: Opioid-Free Total Knee Arthroplasty? Local Infiltration Analgesia Plus Multimodal Blood-Loss Prevention Make it Possible. HSS J. 2019 Jul;15(2):209. doi: 10.1007/s11420-019-09679-x. Epub 2019 Apr 1.</citation>
    <PMID>31327956</PMID>
  </reference>
  <reference>
    <citation>Leas DP, Connor PM, Schiffern SC, D'Alessandro DF, Roberts KM, Hamid N. Opioid-free shoulder arthroplasty: a prospective study of a novel clinical care pathway. J Shoulder Elbow Surg. 2019 Sep;28(9):1716-1722. doi: 10.1016/j.jse.2019.01.013. Epub 2019 May 6.</citation>
    <PMID>31072655</PMID>
  </reference>
  <reference>
    <citation>Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.</citation>
    <PMID>28059869</PMID>
  </reference>
  <reference>
    <citation>Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.</citation>
    <PMID>10861154</PMID>
  </reference>
  <reference>
    <citation>Becchi C, Al Malyan M, Coppini R, Campolo M, Magherini M, Boncinelli S. Opioid-free analgesia by continuous psoas compartment block after total hip arthroplasty. A randomized study. Eur J Anaesthesiol. 2008 May;25(5):418-23. doi: 10.1017/S026502150700302X. Epub 2007 Nov 21.</citation>
    <PMID>18028577</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 19, 2022</last_update_submitted>
  <last_update_submitted_qc>September 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 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>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Analgesics, Opioid</mesh_term>
    <mesh_term>Analgesics</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/NCT04421196
org study id: IRB00254474
nct id: NCT04421196
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of investigators' proposed study is to demonstrate that the following
      two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS)
      scores up to 3 months post-operatively: one that is administered a modified multimodal
      analgesic pathway without opioids and the other administered the current standard multimodal
      analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The
      secondary objective is to demonstrate that these cohorts will also have equivalent functional
      outcomes as determined by both objective measures (such as hip range of motion) and
      patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome
      Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in post-operative pain assessed by the Visual analog scale (VAS) pain scores
time frame: From immediate post-operative period to 3 months post-operatively
description: Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt
measure: Change in pain satisfaction as assessed by Hip Disability and Osteoarthritis Outcome Score (HOOS)
time frame: From pre-operative clinic visit to immediate post-operative period, then to 3 months post-operatively
description: A patient-reported measure that assesses components such as assesses patient pain, satisfaction including stiffness and range of motion, activity limitations-daily living, sports and recreation function, and quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.
measure: Change in Physical Activity level as assessed by the University of California at Los Angeles (UCLA) Scale
time frame: From pre-operative clinic visit to immediate post-operative period, and then to 3 months post-operatively
description: The UCLA scale is a patient-reported measure ranging from 1 to 10. Patients indicate their most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports."
arm group label: Standard multimodal analgesic pathway with opioids
arm group type: No Intervention
description: This is the control group, who will receive the current standard multimodal analgesic regimen, which includes opioids following total hip arthroplasty at Johns Hopkins Bayview Hospital.
The current standard multimodal analgesic regimen utilizes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Opioid (fentanyl) & Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: 0.25 % bupivacaine with epinephrine and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Oxycodone 5-10 mg PO, IV opioids (Morphine, hydromorphone), Acetaminophen 1000 mg PO q6hr
arm group label: Modified multimodal analgesic pathway without opioids
arm group type: Experimental
description: This is the experimental group, who will receive a modified multimodal analgesic regimen, which excludes the use of any opioids.
The modified multimodal analgesic regimen utilizes the following medications:
includes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: Liposomal bupivacaine, 0.25 % bupivacaine with epinephrine, Betamethasone sodium phosphate, betamethasone acetate and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Ketamine IV, Ketorolac 15 mg PO, Acetaminophen 1000 mg PO q6hr
intervention type: Other
intervention name: Exclusion of opioid analgesics
description: The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.
arm group label: Modified multimodal analgesic pathway without opioids
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Julius Oni, M.D.
role: Principal Investigator
affiliation: Johns Hopkins University
citation: Madras BK. The President's Commission on Combating Drug Addiction and the Opioid Crisis: Origins and Recommendations. Clin Pharmacol Ther. 2018 Jun;103(6):943-945. doi: 10.1002/cpt.1050. Epub 2018 Mar 23.
PMID: 29570781
citation: Rodriguez-Merchan EC, Vaquero-Picado A, Ruiz-Perez JS. Correction to: Opioid-Free Total Knee Arthroplasty? Local Infiltration Analgesia Plus Multimodal Blood-Loss Prevention Make it Possible. HSS J. 2019 Jul;15(2):209. doi: 10.1007/s11420-019-09679-x. Epub 2019 Apr 1.
PMID: 31327956
citation: Leas DP, Connor PM, Schiffern SC, D'Alessandro DF, Roberts KM, Hamid N. Opioid-free shoulder arthroplasty: a prospective study of a novel clinical care pathway. J Shoulder Elbow Surg. 2019 Sep;28(9):1716-1722. doi: 10.1016/j.jse.2019.01.013. Epub 2019 May 6.
PMID: 31072655
citation: Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
PMID: 28059869
citation: Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.
PMID: 10861154
citation: Becchi C, Al Malyan M, Coppini R, Campolo M, Magherini M, Boncinelli S. Opioid-free analgesia by continuous psoas compartment block after total hip arthroplasty. A randomized study. Eur J Anaesthesiol. 2008 May;25(5):418-23. doi: 10.1017/S026502150700302X. Epub 2007 Nov 21.
PMID: 18028577
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip
mesh term: Analgesics, Opioid
mesh term: Analgesics
sharing ipd: No