<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/NCT04471545</url>
  </required_header>
  <id_info>
    <org_study_id>NL72737.100.20</org_study_id>
    <nct_id>NCT04471545</nct_id>
  </id_info>
  <brief_title>PECS II Block in Thoracic Outlet Decompression</brief_title>
  <acronym>BLOCKTOS</acronym>
  <official_title>The Use of Pectoral Nerve Block Type II in Patients Undergoing Trans-axillary Thoracic Outlet Decompression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catharina Ziekenhuis Eindhoven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catharina Ziekenhuis Eindhoven</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>
      Rationale: Postoperative pain management after transaxillary thoracic outlet decompression&#xD;
      surgery (TATOD) is difficult. In a retrospective case-control trial, we found evidence that a&#xD;
      PECS II block is able to reduce pain and morphine consumption. This may ultimately lead to&#xD;
      less morphine induced side-effects and improved patient satisfaction. However, the risk of&#xD;
      bias in retrospective research is high. To determine the effect of PECS II in TATOD, a&#xD;
      randomized controlled double blinded trial could offer more valuable scientific evidence. Our&#xD;
      hypothesis is that a PECS II block will reduce pain, opioid use and opioid induced&#xD;
      side-effects in patients undergoing transaxillary TOD (TATOD).&#xD;
&#xD;
      Objective: The aim of the study is to determine the effect of a PECS II block on&#xD;
      postoperative pain and opioid use in patients undergoing TATOD. The secondary objective is to&#xD;
      determine the effect of a PECS II block on opioid induced side effects such as postoperative&#xD;
      nausea and vomitus and the quality of recovery Study design: Single centre randomized&#xD;
      controlled double blinded trial Study population: All patients with Neurogenic Thoracic&#xD;
      Outlet Syndrome (NTOS) selected for TATOD by the TOS multidisciplinary workgroup and based on&#xD;
      the specifications in 2016 SVS reporting standards.&#xD;
&#xD;
      Intervention: The study group will receive a PECS II block with 40 ml ropivacaine 5 mg/ml.&#xD;
      The control group will receive a PECS II block with 40 ml NaCL 0.9%.&#xD;
&#xD;
      Main study parameters/endpoints: Primary outcome parameters are postoperative pain using the&#xD;
      Numeric Rated Scale (NRS) score assessed at rest and when moving and postoperative&#xD;
      morphine-equivalent consumption. Secondary outcome parameters are postoperative Nausea and&#xD;
      Vomitus (PONV) and Quality of Recovery questionnaire (QoR-15).&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: All patients will undergo ultrasound guided injection, after induction of&#xD;
      anaesthesia. The administration of the injection does not invoke any extra physical&#xD;
      discom-fort. Possible complications include hematoma and pneumothorax, however, the risk is&#xD;
      very low (&lt;1%)[1]. In the intervention group, we expect less pain, a reduced need for pain&#xD;
      medica-tion and less postoperative nausea and vomitus. We do not expect an altered&#xD;
      postoperative course in the control group. Patients will be asked to fill out a&#xD;
      questionnaire. Extra blood sam-ples, site visits, physical examinations or other test will&#xD;
      not be done in this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 27, 2020</start_date>
  <completion_date type="Actual">October 3, 2021</completion_date>
  <primary_completion_date type="Actual">October 1, 2021</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>Randomization will be done through Research manager©. This research program has the possibility to create randomisation logs before the start of the trial.&#xD;
A random list of numbers will be generated through Research manager© between 0 and 70. If the number is even, the patient will be allocated to the interventional treatment arm (PECS II block). If the number is uneven, the patient will be allocated to the placebo arm. This list will not be changed during the course of this investigation. Randomisation will be performed by an independent pharmacist from the hospital pharmacy before the start of the trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomisation will be performed by an independent pharmacist from the hospital pharmacy before the start of the trial. This pharmacist has no other task then creating this list and overseeing the preparation of the syringes used in this trial. Syringes will be prepared with ropivacaine or placebo based on this randomisation list. This syringe will be delivered to the preoperative holding with a label that clearly states BLOCKTOS medication, patient name, date of birth and patient number. This procedure makes sure that the patients, surgeons, anaesthesiologist and any other medical personnel are blinded for the randomisation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Numeric Rated Scale</measure>
    <time_frame>Change pain NRS scale is measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge</time_frame>
    <description>Pain is measured using the Numeric Rated Scale (NRS) for pain. This is a psychometric response scale in which patients are asked to rate their pain from 0 to 10 (no pain to extreme pain). This scale is a validated and generally accepted tool to measure pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morphine Equivalent Dose (MED)</measure>
    <time_frame>Total morphine equivalent dose is measured from date of admission until the date of discharge</time_frame>
    <description>Opioid use is measured in Morphine Equivalent Dose (MED). This is a generally accepted tool to quantify opioid use in patients. We will focus on the total opioid consumption.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomitus (PONV)</measure>
    <time_frame>measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge</time_frame>
    <description>Postoperative nausea and/or vomitus (PONV) will be assessed by yes or no answer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Recovery Scale - 15 (QoR-15)</measure>
    <time_frame>measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge</time_frame>
    <description>The QoR-15 is a recently developed and validated patient-reported outcome measurement (PROM) of postoperative quality of recovery.&#xD;
Fifteen questions assess five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Thoracic Outlet Syndrome</condition>
  <arm_group>
    <arm_group_label>Interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention arm: PECS II block with ropivacaine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control arm: PECS II block with placebo (saline)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pectoral nerve block type II</intervention_name>
    <description>A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Interventional group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with NTOS&#xD;
&#xD;
          -  Selected for a trans-axillary thoracic outlet decompression (TATOD) by the TOS&#xD;
             multidisciplinary workgroup.&#xD;
&#xD;
          -  Fit for surgery, defined as ASA (American Society of Anesthesiologists) Classification&#xD;
             of I, II or III.&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Sufficient in speaking and writing the Dutch language&#xD;
&#xD;
          -  Normal liver and renal function&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of TOD (Redo-surgery)&#xD;
&#xD;
          -  Patients with ATOS or VTOS&#xD;
&#xD;
          -  ASA ≥ 4&#xD;
&#xD;
          -  Kidney or liver failure with contra-indication for NSAID or paracetamol&#xD;
&#xD;
          -  Mental retardation&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients with chronic strong opioid use (&gt;3 administrations per week or continuous&#xD;
             transdermal therapy, longer than the last 3 months)&#xD;
&#xD;
          -  Allergy to one or more medications used in the study including, ropivacaine,&#xD;
             dexamethasone, propofol, sufentanil, succinylcholine, paracetamol, NSAID, morphine,&#xD;
             granisetron&#xD;
&#xD;
          -  Patients that have trouble expressing themselves in Dutch. Questionnaires are&#xD;
             completed by the patients and checked by the nurses. The questionnaire is in Dutch. If&#xD;
             there is a language barrier between the questionnaire, the patient or the health care&#xD;
             worker, we believe the validity of the answers is questionable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Catharina Ziekenhuis</name>
      <address>
        <city>Eindhoven</city>
        <state>Noord-Brabant</state>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catharina Ziekenhuis Eindhoven</investigator_affiliation>
    <investigator_full_name>Joep Teijink</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thoracic Outlet Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT04471545
org study id: NL72737.100.20
nct id: NCT04471545
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Rationale: Postoperative pain management after transaxillary thoracic outlet decompression
      surgery (TATOD) is difficult. In a retrospective case-control trial, we found evidence that a
      PECS II block is able to reduce pain and morphine consumption. This may ultimately lead to
      less morphine induced side-effects and improved patient satisfaction. However, the risk of
      bias in retrospective research is high. To determine the effect of PECS II in TATOD, a
      randomized controlled double blinded trial could offer more valuable scientific evidence. Our
      hypothesis is that a PECS II block will reduce pain, opioid use and opioid induced
      side-effects in patients undergoing transaxillary TOD (TATOD).

      Objective: The aim of the study is to determine the effect of a PECS II block on
      postoperative pain and opioid use in patients undergoing TATOD. The secondary objective is to
      determine the effect of a PECS II block on opioid induced side effects such as postoperative
      nausea and vomitus and the quality of recovery Study design: Single centre randomized
      controlled double blinded trial Study population: All patients with Neurogenic Thoracic
      Outlet Syndrome (NTOS) selected for TATOD by the TOS multidisciplinary workgroup and based on
      the specifications in 2016 SVS reporting standards.

      Intervention: The study group will receive a PECS II block with 40 ml ropivacaine 5 mg/ml.
      The control group will receive a PECS II block with 40 ml NaCL 0.9%.

      Main study parameters/endpoints: Primary outcome parameters are postoperative pain using the
      Numeric Rated Scale (NRS) score assessed at rest and when moving and postoperative
      morphine-equivalent consumption. Secondary outcome parameters are postoperative Nausea and
      Vomitus (PONV) and Quality of Recovery questionnaire (QoR-15).

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: All patients will undergo ultrasound guided injection, after induction of
      anaesthesia. The administration of the injection does not invoke any extra physical
      discom-fort. Possible complications include hematoma and pneumothorax, however, the risk is
      very low (<1%)[1]. In the intervention group, we expect less pain, a reduced need for pain
      medica-tion and less postoperative nausea and vomitus. We do not expect an altered
      postoperative course in the control group. Patients will be asked to fill out a
      questionnaire. Extra blood sam-ples, site visits, physical examinations or other test will
      not be done in this study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization will be done through Research manager©. This research program has the possibility to create randomisation logs before the start of the trial.
A random list of numbers will be generated through Research manager© between 0 and 70. If the number is even, the patient will be allocated to the interventional treatment arm (PECS II block). If the number is uneven, the patient will be allocated to the placebo arm. This list will not be changed during the course of this investigation. Randomisation will be performed by an independent pharmacist from the hospital pharmacy before the start of the trial.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomisation will be performed by an independent pharmacist from the hospital pharmacy before the start of the trial. This pharmacist has no other task then creating this list and overseeing the preparation of the syringes used in this trial. Syringes will be prepared with ropivacaine or placebo based on this randomisation list. This syringe will be delivered to the preoperative holding with a label that clearly states BLOCKTOS medication, patient name, date of birth and patient number. This procedure makes sure that the patients, surgeons, anaesthesiologist and any other medical personnel are blinded for the randomisation.
measure: Change in Pain Numeric Rated Scale
time frame: Change pain NRS scale is measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
description: Pain is measured using the Numeric Rated Scale (NRS) for pain. This is a psychometric response scale in which patients are asked to rate their pain from 0 to 10 (no pain to extreme pain). This scale is a validated and generally accepted tool to measure pain.
measure: Morphine Equivalent Dose (MED)
time frame: Total morphine equivalent dose is measured from date of admission until the date of discharge
description: Opioid use is measured in Morphine Equivalent Dose (MED). This is a generally accepted tool to quantify opioid use in patients. We will focus on the total opioid consumption.
measure: Postoperative nausea and vomitus (PONV)
time frame: measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
description: Postoperative nausea and/or vomitus (PONV) will be assessed by yes or no answer.
measure: Quality of Recovery Scale - 15 (QoR-15)
time frame: measured at admission, immediately after surgery and every postoperative day in the morning and in the evening from date of admission until the date of discharge
description: The QoR-15 is a recently developed and validated patient-reported outcome measurement (PROM) of postoperative quality of recovery.
Fifteen questions assess five domains of patient-reported health status: pain, physical comfort, physical independence, psychological support and emotional state. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
arm group label: Interventional group
arm group type: Experimental
description: Intervention arm: PECS II block with ropivacaine
arm group label: Control group
arm group type: Placebo Comparator
description: Control arm: PECS II block with placebo (saline)
intervention type: Procedure
intervention name: Pectoral nerve block type II
description: A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided
arm group label: Control group
arm group label: Interventional group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Catharina Ziekenhuis Eindhoven
investigator full name: Joep Teijink
investigator title: Professor
mesh term: Thoracic Outlet Syndrome
sharing ipd: Yes