<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/NCT03036514</url>
  </required_header>
  <id_info>
    <org_study_id>16/45/479</org_study_id>
    <nct_id>NCT03036514</nct_id>
  </id_info>
  <brief_title>Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia After Back Surgery.</brief_title>
  <official_title>Sublingual Sufentanil Tablet System (SSTS) Versus Intravenous Patient Controlled Analgesia (PCIA) With Morphine for Postoperative Pain After Back Surgery. A Single Center Case-control Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Antwerp</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>
      In this study, numeric rating scale (NRS) and side effects are measured after usage of a&#xD;
      sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled&#xD;
      analgesia (PCIA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile&#xD;
      with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the&#xD;
      postoperative phase after back surgery. The common use of PCIA with morphine is associated&#xD;
      with a rather slow onset-time and active metabolites, with occurrence of potential harmful&#xD;
      side effects as sedation and desaturation.&#xD;
&#xD;
      This mono-centric project involving American Society of Anesthesiologists (ASA)&#xD;
      classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited.&#xD;
      Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the&#xD;
      first 72h postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Single center case-control study design</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Rating Scale (NRS)</measure>
    <time_frame>72 hours postoperatively</time_frame>
    <description>Pain assessment by NRS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of side effect</measure>
    <time_frame>72 hours postoperatively</time_frame>
    <description>Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sublingual sufentanil tablet system (SSTS) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. Orange-coloured tablets containing 15mcg sufentanil, the patient-controlled device is designed to deliver a single tablet with a minimum lockout interval of 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient-controlled intravenous analgesia (PCIA) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. This classic patient-controlled IV-pump contains 1mg/ml morphine and 50mcg/ml dehydrobenzperidol. Pump characteristics include 1ml each asked bolus, lockout interval of 8 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sublingual sufentanil tablet system</intervention_name>
    <description>Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.</description>
    <arm_group_label>Case</arm_group_label>
    <other_name>SSTS</other_name>
    <other_name>Zalviso</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Patient-controlled intravenous analgesia</intervention_name>
    <description>Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>PCIA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled elective laminectomy or spinal fusion&#xD;
&#xD;
          -  American Society Anesthesiology Classification system (ASA) I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic opioid use (&gt;3 months)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  obstructive sleep apnea syndrome&#xD;
&#xD;
          -  supplemental oxygen therapy at home&#xD;
&#xD;
          -  postoperative use of non-steroidal anti-inflammatory or anti-neuropathic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Davina Wildemeersch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University hospital Antwerp</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Davina Wildemeersch</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>numeric rating scale</keyword>
  <keyword>opioid side effects</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>
  </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/NCT03036514
org study id: 16/45/479
nct id: NCT03036514
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, numeric rating scale (NRS) and side effects are measured after usage of a
      sublingual sufentanil tablet system (SSTS) in comparison to intravenous patient controlled
      analgesia (PCIA).
Sublingual sufentanil tablet system (SSTS) is compared in pain relief and side effect profile
      with the routinely used intravenous patient controlled analgesia (PCIA) with morphine in the
      postoperative phase after back surgery. The common use of PCIA with morphine is associated
      with a rather slow onset-time and active metabolites, with occurrence of potential harmful
      side effects as sedation and desaturation.

      This mono-centric project involving American Society of Anesthesiologists (ASA)
      classification I-II patients undergoing elective neurosurgery (laminectomy) are recruited.
      Enrolled patients undergo numeric rating scale (NRS) and side effect questionnaire during the
      first 72h postoperatively.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Single center case-control study design
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Numeric Rating Scale (NRS)
time frame: 72 hours postoperatively
description: Pain assessment by NRS
measure: Evaluation of side effect
time frame: 72 hours postoperatively
description: Evaluation of pruritus, constipation, desaturation, nausea, vomiting, urine retention, hypotension, dizziness
arm group label: Case
arm group type: Experimental
description: Sublingual sufentanil tablet system (SSTS) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. Orange-coloured tablets containing 15mcg sufentanil, the patient-controlled device is designed to deliver a single tablet with a minimum lockout interval of 20 minutes.
arm group label: Control
arm group type: Active Comparator
description: Patient-controlled intravenous analgesia (PCIA) for postoperative pain relief after laminectomy or spinal fusion in the first 72 hour period. This classic patient-controlled IV-pump contains 1mg/ml morphine and 50mcg/ml dehydrobenzperidol. Pump characteristics include 1ml each asked bolus, lockout interval of 8 minutes.
intervention type: Device
intervention name: Sublingual sufentanil tablet system
description: Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
arm group label: Case
other name: SSTS
other name: Zalviso
intervention type: Drug
intervention name: Patient-controlled intravenous analgesia
description: Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
arm group label: Control
other name: PCIA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Davina Wildemeersch, MD
role: Principal Investigator
affiliation: Universiteit Antwerpen
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Davina Wildemeersch
investigator title: MD
mesh term: Pain, Postoperative
mesh term: Sufentanil
sharing ipd: No