<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/NCT03242668</url>
  </required_header>
  <id_info>
    <org_study_id>103HospitalVMMU</org_study_id>
    <nct_id>NCT03242668</nct_id>
  </id_info>
  <brief_title>Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery</brief_title>
  <official_title>Patient Controlled Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nguyen Trung Kien</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nguyen Truong Giang, PhD. Associate Prof.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vietnam Military Medical 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>
      To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was carried out on thirty patients who underwent video-assisted thoracic&#xD;
      surgery.Paravertebral space was identified by loss of resistance technique under&#xD;
      video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of&#xD;
      bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled&#xD;
      analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes.&#xD;
      Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the&#xD;
      heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in&#xD;
      three postoperative consecutive days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>30 patients, with American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery , were enrolled in this randomised observer blinded prospective clinical study. Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more, allergy to any of the study drugs, patients having any contraindication for paravertebral block, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease were excluded from this study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS score at rest and on coughing</measure>
    <time_frame>72 hours</time_frame>
    <description>Using VAS scale (Atrazennica)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesia effects on respiratory function</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood gas values</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number dermatome inhibition</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>Using pin-prick test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue analgesia</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>When VAS score equal to or more than 4 using fentanyl to manage pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>Using questionaire with 4 levels :not good,satisfied,good,very good</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Side effects and complications</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>Respiratory depression (respiratory rate &lt; 8 breaths/min), ,confusion, sedation, urinary retention, nausea, vomiting, headache and pruritus was evaluated.</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>Using monitoring (Philips)</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood pressure</measure>
    <time_frame>three postoperative consecutive days</time_frame>
    <description>Using monitoring (Philips)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>PVB using PVC for PCA in VATS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA with background rate 3ml/h, bolus dose 2ml was infused through PVC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VATS</intervention_name>
    <description>General anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed.</description>
    <arm_group_label>PVB using PVC for PCA in VATS</arm_group_label>
    <other_name>Video-Assisted Thoracic Surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PVB using PVC</intervention_name>
    <description>At the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area.</description>
    <arm_group_label>PVB using PVC for PCA in VATS</arm_group_label>
    <other_name>Paravertebral block using paravertebral catheter</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PCA</intervention_name>
    <description>PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC.</description>
    <arm_group_label>PVB using PVC for PCA in VATS</arm_group_label>
    <other_name>Patient controlled analgesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists class I to III risk undergoing elective VATS,&#xD;
             aged 32-72 years, scheduled for lung resection surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refused to participate, less than 18 years of age, ASA physical status 3&#xD;
             or more,, allergy to any of the study drugs, patients having any contraindication to&#xD;
             placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain&#xD;
             syndrome, chronic analgesic use and psychiatric disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vietnam Military Medical University</name>
      <address>
        <city>Hanoi</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Vietnam Military Medical University</investigator_affiliation>
    <investigator_full_name>Nguyen Trung Kien</investigator_full_name>
    <investigator_title>Corresponding author,Clinical Research</investigator_title>
  </responsible_party>
  <keyword>paravertebral block,PVC,PCA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 24, 2017</submitted>
    <returned>October 23, 2017</returned>
    <submitted>October 31, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>April 30, 2018</submitted>
    <returned>November 20, 2018</returned>
  </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/NCT03242668
org study id: 103HospitalVMMU
nct id: NCT03242668
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.
The study was carried out on thirty patients who underwent video-assisted thoracic
      surgery.Paravertebral space was identified by loss of resistance technique under
      video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of
      bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled
      analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes.
      Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the
      heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in
      three postoperative consecutive days.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 30 patients, with American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery , were enrolled in this randomised observer blinded prospective clinical study. Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more, allergy to any of the study drugs, patients having any contraindication for paravertebral block, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease were excluded from this study.
primary purpose: Treatment
masking: None (Open Label)
measure: VAS score at rest and on coughing
time frame: 72 hours
description: Using VAS scale (Atrazennica)
measure: Analgesia effects on respiratory function
time frame: three postoperative consecutive days
description: Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index
measure: Arterial blood gas values
time frame: three postoperative consecutive days
description: Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)
measure: The number dermatome inhibition
time frame: three postoperative consecutive days
description: Using pin-prick test
measure: Rescue analgesia
time frame: three postoperative consecutive days
description: When VAS score equal to or more than 4 using fentanyl to manage pain
measure: Patient's satisfaction
time frame: three postoperative consecutive days
description: Using questionaire with 4 levels :not good,satisfied,good,very good
measure: Side effects and complications
time frame: three postoperative consecutive days
description: Respiratory depression (respiratory rate < 8 breaths/min), ,confusion, sedation, urinary retention, nausea, vomiting, headache and pruritus was evaluated.
measure: Heart rate
time frame: three postoperative consecutive days
description: Using monitoring (Philips)
measure: Blood pressure
time frame: three postoperative consecutive days
description: Using monitoring (Philips)
arm group label: PVB using PVC for PCA in VATS
arm group type: Experimental
description: The VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA with background rate 3ml/h, bolus dose 2ml was infused through PVC.
intervention type: Procedure
intervention name: VATS
description: General anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed.
arm group label: PVB using PVC for PCA in VATS
other name: Video-Assisted Thoracic Surgery
intervention type: Procedure
intervention name: PVB using PVC
description: At the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area.
arm group label: PVB using PVC for PCA in VATS
other name: Paravertebral block using paravertebral catheter
intervention type: Drug
intervention name: PCA
description: PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC.
arm group label: PVB using PVC for PCA in VATS
other name: Patient controlled analgesia
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Vietnam
responsible party type: Sponsor-Investigator
investigator affiliation: Vietnam Military Medical University
investigator full name: Nguyen Trung Kien
investigator title: Corresponding author,Clinical Research
mesh term: Pain, Postoperative
sharing ipd: Undecided
submitted: September 24, 2017
returned: October 23, 2017
submitted: October 31, 2017
submission canceled: Unknown
submitted: April 30, 2018
returned: November 20, 2018