<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/NCT04448457</url>
  </required_header>
  <id_info>
    <org_study_id>P2017/348</org_study_id>
    <nct_id>NCT04448457</nct_id>
  </id_info>
  <brief_title>Sufentanil Sublingual Tablet System for Postoperative Pain Management After Total Knee Arthroplasty</brief_title>
  <official_title>Sufentanil Sublingual Tablet System For Management Of Postoperative Pain In Enhanced Recovery After Surgery Pathway For Total Knee Arthroplasty: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Tivoli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Tivoli</source>
  <oversight_info>
    <has_dmc>No</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 aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System&#xD;
      (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context&#xD;
      of early rehabilitation program.&#xD;
&#xD;
      SSTS is a novel patient controlled analgesia system wich does not require intravenous access,&#xD;
      potentially improving pain control and promoting mobilization.&#xD;
&#xD;
      SSTS will be randomly compared to nurse-driven oral Oxycodone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids,&#xD;
      non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is&#xD;
      associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We&#xD;
      compare the efficacy of SSTS and oral Oxycodone in this context.&#xD;
&#xD;
      After written informed consent, patients will be randomly assigned postoperatively to SSTS or&#xD;
      Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will&#xD;
      be analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain score assessed at 24 hours</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>A numerical pain scale anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically 24 hours after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain scores assessed over 48 hours</measure>
    <time_frame>2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery</time_frame>
    <description>A numerical pain scale anchored by &quot;no pain&quot; (score of 0) and &quot;pain as bad as it could be&quot; or &quot;worst imaginable pain&quot; (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first mobilization</measure>
    <time_frame>2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery</time_frame>
    <description>Successful mobilization with or without aid assessed at specific timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>At completion of the study period of 48 hours</time_frame>
    <description>Satisfaction for the method of pain control assessed using Patient Global Assessment (PGA) of the method of pain control questionnaire at the completion of the 48h study period which consist on a 4-point categorical scale, where 1 = poor, 2 = fair, 3 = good, and 4 = excellent.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of nausea and vomiting</measure>
    <time_frame>At completion of the study period of 48 hours</time_frame>
    <description>Percentage of patients who experienced nausea or vomiting during the study period</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>SSTS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxycodone group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sufentanil Sublingual Tablet</intervention_name>
    <description>15 mcg with lockout interval of 20 min</description>
    <arm_group_label>SSTS group</arm_group_label>
    <other_name>Zalviso</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone oral tablet and oxycodone extended-release oral tablet</intervention_name>
    <description>Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg</description>
    <arm_group_label>Oxycodone group</arm_group_label>
    <other_name>OxyNorm</other_name>
    <other_name>OxyContin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (age ≥ 18 years)&#xD;
&#xD;
          -  Scheduled for unilateral total knee arthroplasty under spinal anesthesia&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) class 1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to medication used in our multimodal analgesia protocol (solumedrol,&#xD;
             celecoxib, acetaminophen, ropivacaine)&#xD;
&#xD;
          -  Allergy to study medications&#xD;
&#xD;
          -  History of addiction or preoperative chronic use of opioids&#xD;
&#xD;
          -  Unicompartmental or revision knee replacement&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emmanuel Noel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Tivoli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chu Tivoli</name>
      <address>
        <city>La Louviere</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SSTS</keyword>
  <keyword>Oxycodone</keyword>
  <keyword>Enhanced recovery after surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sufentanil</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04448457
org study id: P2017/348
nct id: NCT04448457
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the effectiveness of Sublingual Sufentanil Tablets System
      (SSTS, Zalviso ®) to control postoperative pain after total knee arthroplasty in the context
      of early rehabilitation program.

      SSTS is a novel patient controlled analgesia system wich does not require intravenous access,
      potentially improving pain control and promoting mobilization.

      SSTS will be randomly compared to nurse-driven oral Oxycodone.
Even with multimodal analgesia (combining local anesthetic infiltration, corticosteroids,
      non-steroidal anti-inflammatory drugs and acetaminophen), total knee arthroplasty is
      associated with acute moderate-to-severe postoperative pain requiring opioids treatment. We
      compare the efficacy of SSTS and oral Oxycodone in this context.

      After written informed consent, patients will be randomly assigned postoperatively to SSTS or
      Oral oxycodone group at a ratio 1:1. Pain scores, mobilization and patient satisfaction will
      be analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative pain score assessed at 24 hours
time frame: 24 hours after surgery
description: A numerical pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically 24 hours after surgery
measure: Postoperative pain scores assessed over 48 hours
time frame: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
description: A numerical pain scale anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]) will be used to evaluate pain at rest and dynamically
measure: Time to first mobilization
time frame: 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours, 48 hours after surgery
description: Successful mobilization with or without aid assessed at specific timepoints
measure: Patient satisfaction
time frame: At completion of the study period of 48 hours
description: Satisfaction for the method of pain control assessed using Patient Global Assessment (PGA) of the method of pain control questionnaire at the completion of the 48h study period which consist on a 4-point categorical scale, where 1 = poor, 2 = fair, 3 = good, and 4 = excellent.
measure: Incidence of nausea and vomiting
time frame: At completion of the study period of 48 hours
description: Percentage of patients who experienced nausea or vomiting during the study period
arm group label: SSTS group
arm group type: Experimental
description: Patients received sufentanil nanotab patient controlled analgesia (PCA) system (Zalviso) 15 mcg with 20 min of lockout interval during 48 hours postoperatively
arm group label: Oxycodone group
arm group type: Active Comparator
description: Patients received oxycodone extended-release tablet (OxyContin) 10 mg every 12 hours systematically plus Oxycodone 5 mg every 6 hours if numeric rating scale is above 3 during the 48 hours postoperatively
intervention type: Drug
intervention name: Sufentanil Sublingual Tablet
description: 15 mcg with lockout interval of 20 min
arm group label: SSTS group
other name: Zalviso
intervention type: Drug
intervention name: Oxycodone oral tablet and oxycodone extended-release oral tablet
description: Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg
arm group label: Oxycodone group
other name: OxyNorm
other name: OxyContin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Emmanuel Noel, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Tivoli
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Sufentanil
mesh term: Oxycodone