<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/NCT03756987</url>
  </required_header>
  <id_info>
    <org_study_id>K2018-10-001</org_study_id>
    <nct_id>NCT03756987</nct_id>
  </id_info>
  <brief_title>Does ESPB Improve Postoperative Quality of Recovery After VATS</brief_title>
  <official_title>Does Ultrasound-guided Erector Spinae Plane Block Improve Postoperative Quality of Recovery After Video-assisted Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fujian Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fujian Provincial Hospital</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>
      Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery. Despite reduced&#xD;
      surgical trauma compared to the traditional thoracotomy approach, pain control after VATS&#xD;
      remains challenging. Regional analgesia may be a crucial component of multimodal&#xD;
      postoperative pain management. The use of nerve blocks, such as the recently described&#xD;
      erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has&#xD;
      the potential to improve patient recovery. This study aims to test the hypothesis that&#xD;
      ultrasound-guided SPB would improve the quality of recovery after VATS by reducing acute&#xD;
      postsurgical pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      VATS is a minimally invasive surgical technique to remove intrathoracic lesions. VATS has&#xD;
      become increasingly popular and gradually becoming the standard of care for lung surgery.&#xD;
      Although acute pain after VATS is less than the traditional thoracotomy, patients still&#xD;
      experience moderate amount of pain within the first 24 hours. However, the optimal regional&#xD;
      analgesic technique for VATS procedures has not been established.&#xD;
&#xD;
      Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been tried to improve&#xD;
      postoperative analgesia after VATS. Although TEA and PVB provides superior analgesia, these&#xD;
      technologies accompanied by the rare but serious complications involving epidural hematoma,&#xD;
      pneumothorax and total spinal anesthesia.&#xD;
&#xD;
      Erector spinae plane block (ESPB) is a novel and simple ultrasound-guided regional anesthetic&#xD;
      technique, providing analgesia for the ipsilateral hemithorax. Ultrasound guidance is&#xD;
      believed to improve peripheral and regional nerve block success rates and safety. ESPB is a&#xD;
      technically easy to perform. ESPB has only been reported in case series but so far, no&#xD;
      adverse events such as hypotension, hematoma or infection has been reported.&#xD;
&#xD;
      Given its safety, ease of performance and efficacy, the study aims to verify the hypothesis&#xD;
      that combines ESPB with general anesthesia would accelerate functional recovery after breast&#xD;
      cancer surgery. Our secondary aims were to examine ESPB's effect on analgesic outcomes (e.g.,&#xD;
      postoperative pain intensity, cumulative opioid consumption, postoperative nausea and&#xD;
      vomiting, dizziness, the postanesthesia care unit discharge time and patients' satisfaction)&#xD;
      in patients undergoing VATS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 28, 2018</start_date>
  <completion_date type="Actual">November 14, 2019</completion_date>
  <primary_completion_date type="Actual">November 12, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The randomization sequence will be computer generated. Allocation concealment will be carried out via concealed assignments in opaque, sealed, and consecutively numbered envelopes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the 40-item Quality of Recovery (QoR-40) score</measure>
    <time_frame>The QoR-40 questionnaire was completed by patients at 24 hours after surgery.</time_frame>
    <description>QoR-40 incorporates 40 questions assessing 5 dimensions of recovery, including emotional status, physical comfort, psychological support, physical independence, and pain. The global QoR-40 score ranges from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>postoperative pain: numeric rating scale</measure>
    <time_frame>Acute postoperative pain was assessed using an numeric rating scale (NRS) at 0.5, 1, 2, 4, 8, 12, 24, and 48 hours following video-assisted thoracic surgery.</time_frame>
    <description>0-10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative opioid consumption</measure>
    <time_frame>Up to 48 hours after surgery.</time_frame>
    <description>We recorded opioid(sufentanil) consumption at 48 hours after surgery. consumption at 6, 24, and 48 hours after surgery.cumulative opioid (sufentanil) consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PACU discharge time</measure>
    <time_frame>Up to 2 hours</time_frame>
    <description>Post-anesthetic recovery length of stay in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of nausea and vomiting</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Patient reported sensation of nausea and incidence of vomiting related to opioid intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of dizziness</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>Patient reported incidence of dizziness related to opioid intake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's satisfaction: numeric rating scale</measure>
    <time_frame>Patient's satisfaction was evaluated at 48 hours postoperatively.</time_frame>
    <description>Patient's satisfaction was evaluated with a 10-point numerical rating scale ranging from 1 (highly unsatisfactory) to 10 (highly satisfactory).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>ESPB group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine Injection</intervention_name>
    <description>Ropivacaine will be injected in the erector spinae plane</description>
    <arm_group_label>ESPB group</arm_group_label>
    <other_name>ESPB group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Normal saline will be injected in the erector spinae plane.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists' physical status class of I or II&#xD;
&#xD;
          -  scheduled for elective VATS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a history of allergy to local anesthetics&#xD;
&#xD;
          -  known coagulation disorders&#xD;
&#xD;
          -  infection near the puncture site&#xD;
&#xD;
          -  chronic opioid use&#xD;
&#xD;
          -  inability to communicate,&#xD;
&#xD;
          -  other reasons that not appropriate for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaochun Zheng, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fujian Provincial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yusheng Yao</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>January 26, 2020</last_update_submitted>
  <last_update_submitted_qc>January 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fujian Provincial Hospital</investigator_affiliation>
    <investigator_full_name>Yao Yusheng</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>ultrasound-guided</keyword>
  <keyword>erector spinae plane block</keyword>
  <keyword>quality of recovery</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>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>It is not yet known if there will be a plan to make individual participant data (IPD) available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 3 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>All of the individual participant data collected during the trial, the study protocol, statistical analysis plan, and clinical study report can be accessed with approval from the corresponding author.</ipd_access_criteria>
  </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/NCT03756987
org study id: K2018-10-001
nct id: NCT03756987
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery. Despite reduced
      surgical trauma compared to the traditional thoracotomy approach, pain control after VATS
      remains challenging. Regional analgesia may be a crucial component of multimodal
      postoperative pain management. The use of nerve blocks, such as the recently described
      erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has
      the potential to improve patient recovery. This study aims to test the hypothesis that
      ultrasound-guided SPB would improve the quality of recovery after VATS by reducing acute
      postsurgical pain.
VATS is a minimally invasive surgical technique to remove intrathoracic lesions. VATS has
      become increasingly popular and gradually becoming the standard of care for lung surgery.
      Although acute pain after VATS is less than the traditional thoracotomy, patients still
      experience moderate amount of pain within the first 24 hours. However, the optimal regional
      analgesic technique for VATS procedures has not been established.

      Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been tried to improve
      postoperative analgesia after VATS. Although TEA and PVB provides superior analgesia, these
      technologies accompanied by the rare but serious complications involving epidural hematoma,
      pneumothorax and total spinal anesthesia.

      Erector spinae plane block (ESPB) is a novel and simple ultrasound-guided regional anesthetic
      technique, providing analgesia for the ipsilateral hemithorax. Ultrasound guidance is
      believed to improve peripheral and regional nerve block success rates and safety. ESPB is a
      technically easy to perform. ESPB has only been reported in case series but so far, no
      adverse events such as hypotension, hematoma or infection has been reported.

      Given its safety, ease of performance and efficacy, the study aims to verify the hypothesis
      that combines ESPB with general anesthesia would accelerate functional recovery after breast
      cancer surgery. Our secondary aims were to examine ESPB's effect on analgesic outcomes (e.g.,
      postoperative pain intensity, cumulative opioid consumption, postoperative nausea and
      vomiting, dizziness, the postanesthesia care unit discharge time and patients' satisfaction)
      in patients undergoing VATS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The randomization sequence will be computer generated. Allocation concealment will be carried out via concealed assignments in opaque, sealed, and consecutively numbered envelopes.
measure: the 40-item Quality of Recovery (QoR-40) score
time frame: The QoR-40 questionnaire was completed by patients at 24 hours after surgery.
description: QoR-40 incorporates 40 questions assessing 5 dimensions of recovery, including emotional status, physical comfort, psychological support, physical independence, and pain. The global QoR-40 score ranges from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).
measure: postoperative pain: numeric rating scale
time frame: Acute postoperative pain was assessed using an numeric rating scale (NRS) at 0.5, 1, 2, 4, 8, 12, 24, and 48 hours following video-assisted thoracic surgery.
description: 0-10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)
measure: cumulative opioid consumption
time frame: Up to 48 hours after surgery.
description: We recorded opioid(sufentanil) consumption at 48 hours after surgery. consumption at 6, 24, and 48 hours after surgery.cumulative opioid (sufentanil) consumption
measure: PACU discharge time
time frame: Up to 2 hours
description: Post-anesthetic recovery length of stay in minutes
measure: Incidence of nausea and vomiting
time frame: Up to 48 hours
description: Patient reported sensation of nausea and incidence of vomiting related to opioid intake.
measure: Incidence of dizziness
time frame: Up to 48 hours
description: Patient reported incidence of dizziness related to opioid intake.
measure: patient's satisfaction: numeric rating scale
time frame: Patient's satisfaction was evaluated at 48 hours postoperatively.
description: Patient's satisfaction was evaluated with a 10-point numerical rating scale ranging from 1 (highly unsatisfactory) to 10 (highly satisfactory).
arm group label: ESPB group
arm group type: Experimental
description: Patient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.
arm group label: Control Group
arm group type: Placebo Comparator
description: Patient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.
intervention type: Drug
intervention name: Ropivacaine Injection
description: Ropivacaine will be injected in the erector spinae plane
arm group label: ESPB group
other name: ESPB group
intervention type: Drug
intervention name: Normal saline
description: Normal saline will be injected in the erector spinae plane.
arm group label: Control Group
other name: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xiaochun Zheng, MD
role: Study Director
affiliation: Fujian Provincial Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fujian Provincial Hospital
investigator full name: Yao Yusheng
investigator title: Clinical Professor
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: Yes
ipd description: It is not yet known if there will be a plan to make individual participant data (IPD) available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 3 months and ending 3 years following article publication.
ipd access criteria: All of the individual participant data collected during the trial, the study protocol, statistical analysis plan, and clinical study report can be accessed with approval from the corresponding author.