xml: <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/NCT06016777</url>
    </required_header>
    <id_info>
      <org_study_id>ChinaJapanFHAnesth2</org_study_id>
      <nct_id>NCT06016777</nct_id>
    </id_info>
    <brief_title>Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery</brief_title>
    <official_title>Optimization of Perioperative Analgesia Protocol for Uniportal Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China-Japan Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China-Japan Friendship Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Trial design Despite video-assisted thoracic technology and procedure specific postoperative&#xD;
        pain management (PROSPECT) have been promoted through recent years, thoracic surgery is still&#xD;
        considered to be one of the most painful of surgical procedures. This study aims to optimize&#xD;
        these conditions according to different perioperative analgesic modes recommended at present.&#xD;
        This will be a single-blind randomized study to investigate the optimal analgesic effect of&#xD;
        thoracic paravertebral block (TPB), erector spinae block (ESB), or sufentanil patient&#xD;
        controlled intravenous analgesia (PCIA) for uniportal video-assisted thoracoscopic surgery&#xD;
        (uVATS) and using minimally invasive drainage.&#xD;
  &#xD;
        Methods One-hundred and two patients undergoing uVATS will be enrolled. Patients will be&#xD;
        randomly assigned to PVB group (20mL 0.3% ropivacaine with dexamethasone), ESB group (20mL&#xD;
        0.3% ropivacaine with dexamethasone) or CON group. PCIA with sufentanil will be provided to&#xD;
        all patients after surgery. Primary outcome will be total opioid consumption from the end of&#xD;
        the surgery to the time of discharge. Secondary outcomes consist of postoperative pain score,&#xD;
        postoperative chronic pain, both at rest and during coughing, sensations of touch and pain on&#xD;
        the chest wall, non-opioid analgesic drug use, length of stay (LOS), ambulation time, total&#xD;
        cost of hospitalization and long-term postoperative analgesia. Adverse reaction to analgesics&#xD;
        and adverse event related to regional block will also be recorded.&#xD;
  &#xD;
        Ethics and dissenmination This study is approved by the Ethics Committee of China-Japan&#xD;
        Friendship Hospital (ID 2022-KY-127-1). The results will be published in peer-reviewed&#xD;
        journals.&#xD;
  &#xD;
        Key words: fast-track; Enhanced Recovery After Surgery; uniportal video-assisted&#xD;
        thoracoscopic surgery; randomized controlled trial; thoracoscopic; ultrasonic guidance;&#xD;
        paravertebral block; erector spinal block&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, randomized controlled study. Patients who are scheduled for elective&#xD;
        uniportal thoracoscopic surgery in our hospital will be enrolled. Patients will be randomly&#xD;
        assigned to one of the three groups: ultrasound-guided paravertebral block, ultrasound-guided&#xD;
        erector spinae block, or intravenous patient-controlled analgesia pump group. Different nerve&#xD;
        block operation schemes will be used in different groups.&#xD;
  &#xD;
        In any of the three groups, general anesthesia will be performed according to the standard,&#xD;
        and multi-mode analgesic treatment will be appied as the combination of NSAIDs analgesics,&#xD;
        opioid analgesics, and postoperative rescue analgesic treatment. Participants will be&#xD;
        followed up at 1, 4, 12, 18 hours, on 1, 2, 3, 4, 7 days, and in 1, 2, 3, 4, 6 months after&#xD;
        surgery. At each follow-up visit, rest and cough pain level will be recorded, and sense of&#xD;
        touch and pain in the chest will be examined. Additional analgesic treatment will be given if&#xD;
        necessary.&#xD;
  &#xD;
        Comparisons of the postoperative analgesic use, cough and rest pain, ambulation time, length&#xD;
        of hospital stay, and hospital costs will be made in the three groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 10, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>This will be a parallel-group, single-blind, randomized controlled trial. Patients are expected to be enrolled in the trial within 8 months. Participants will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block (PVB+PCIA group), ultrasound-guided erector spinae block(ESB+PCIA group) , or intravenous patient-controlled analgesia pump group (PCIA group). Different nerve block operation schemes will be used in different groups.Except for different nerve block schemes, all the participants will have the same methods and choices of medicine for other kinds of rescue analgesia regimens.The participants and the follow-up evaluation doctors are not aware of the group assignment, and the surgeon and anesthesiologist will not know the grouping code until the beginning of the surgery. In this way, the analgesic effect of each subject can be fairly evaluated.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Patients will be grouped by block randomization method (1:1:1) by a researcher who is unaware of the meaning of the group code. Patients will be stratified by ID numbers with a block of 6. Within each block, random sequences between 0 and 1 are generated. The group code (A, B or C) will be defined as the remainder of the serial number divided by three. The group code will be put in a light-proof envelope. Patients with the envelope will be transferred to the OR, unaware of the group assignment throughout the study. After induction, the anesthesiologist opens the light-proof envelope and get the group code. Group codes will be recorded in the CRF table with the cards destroyed. Only the principal investigator and the anesthesiologists know the intervention represented by the group code. The anesthesiologists will not involve in postoperative follow-ups or data collection. Neither doctors in charge of postoperative follow-ups nor the statisticians will know the specific interventions.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>total opioid consumption</measure>
      <time_frame>up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.</time_frame>
      <description>total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative pain score assessed by Visual Analogue Scale VAS (1-10)</measure>
      <time_frame>from the time at the end of surgery to 24 weeks after surgery</time_frame>
      <description>rest and cough pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>postoperative pain score assessed by Numeric Rating Scales, NRS (1-10)</measure>
      <time_frame>from the time at the end of surgery to 24 weeks after surgery</time_frame>
      <description>rest and cough pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sensations of touch on the chest wall</measure>
      <time_frame>from the time at the end of surgery to 24 weeks after surgery</time_frame>
      <description>difference in tactile sense on bilateral chest-wall. Tactile sensation and cold sensation will be measured at four points (&lt;3cm near the incision, and on the other side on the symmetrical chest wall, and at the point of bilateral mid-clavicular-costal arch) with an alcohol-stained cotton swab</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>non-opioid analgesic drug use</measure>
      <time_frame>from the time at the end of surgery to 24 weeks after surgery</time_frame>
      <description>number of patients with long-term (≥3 days) use of non-opioid analgesic drug</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of stay (LOS)</measure>
      <time_frame>up to 1 month, LOS is the amount of days the patient spends in the hospital, determined by subtracting the date of admission from the date of discharge</time_frame>
      <description>days of hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ambulation time</measure>
      <time_frame>up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure</time_frame>
      <description>first time of successful activity off bed, the time between the end of surgery to the time of the first successful ambulation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>total cost of hospitalization</measure>
      <time_frame>up to 1 month, total charges settled on the day of discharge</time_frame>
      <description>the in-patients costs total cost of hospitalization=medication cost + hospitalization cost + nursing cost + delay compensation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>long-term postoperative analgesia</measure>
      <time_frame>from the time at the end of surgery to 24 weeks after surgery</time_frame>
      <description>number of patient who needs long-term postoperative analgesia (≥3 days after discharge)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">102</enrollment>
    <condition>Uniportal Video-assisted Thoracic Surgery</condition>
    <arm_group>
      <arm_group_label>PVB+PCIA group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>ESB+PCIA group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>PCIA group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump</intervention_name>
      <description>Patients in this group will receive ultrasound-guided paraspinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage &lt;5μg/hour.</description>
      <arm_group_label>PVB+PCIA group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump</intervention_name>
      <description>Patients in this group will receive ultrasound-guided erector spinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage &lt;5μg/hour.</description>
      <arm_group_label>ESB+PCIA group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Patient-controlled intravenous analgesia pump</intervention_name>
      <description>Patients in this group will not receive regional block. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage &lt;5μg/hour.</description>
      <arm_group_label>ESB+PCIA group</arm_group_label>
      <arm_group_label>PCIA group</arm_group_label>
      <arm_group_label>PVB+PCIA group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥18 years&#xD;
  &#xD;
            2. ASA I-IIa&#xD;
  &#xD;
            3. Early stage lung cancer or intrathoracic tissue biopsy, suitable for elective uVATSb&#xD;
  &#xD;
            4. Informed consent obtained&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. ASA≥III&#xD;
  &#xD;
            2. History of intrathoracic or chest wall surgery&#xD;
  &#xD;
            3. Chronic pain&#xD;
  &#xD;
            4. Pre-operative analgesic medication use&#xD;
  &#xD;
            5. NSAIDsc contraindications: aspirin asthma, allergic to NSAIDs, peptic ulcer, liver and&#xD;
               kidney insufficiency, high risk of thrombotic events&#xD;
  &#xD;
            6. Active autoimmune disease&#xD;
  &#xD;
            7. Allergic to local anesthetics&#xD;
  &#xD;
            8. Severe coagulation dysfunction, contraindicated for nerve block&#xD;
  &#xD;
            9. Soft tissue infections of the chest wall&#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>Zhen Rong ZHANG, Doctor</last_name>
      <role>Study Director</role>
      <affiliation>China-Japan Friendship Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Li Fang WANG, Doctor</last_name>
      <phone>+8615011393879</phone>
      <email>lilythewolf@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhen Rong ZHANG, Doctor</last_name>
      <phone>+8613811000378</phone>
      <email>doctor_zzr@126.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
      <investigator_full_name>Li Fang Wang</investigator_full_name>
      <investigator_title>attending doctor</investigator_title>
    </responsible_party>
    <keyword>fast-track</keyword>
    <keyword>Enhanced Recovery After Surgery</keyword>
    <keyword>uniportal video-assisted thoracoscopic surgery</keyword>
    <keyword>randomized controlled trial</keyword>
    <keyword>thoracoscopic; ultrasonic guidance</keyword>
    <keyword>paravertebral block</keyword>
    <keyword>erector spinal block</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Security cameras are set up next to both the computer and the cabinet for data storage. The surveillance video will be available only to medical staff and the principal investigator. Access to data will be restricted to authorized personnel, including ethics committee directors, principal investigator and authorized personnel. Access to paper documents as well as electronic data must be registered, with the name of operator and detailed reasons recorded.&#xD;
  The results and conclusions of our research will be reported to all the participants, research team, and the public in peer-reviewed journal. The investigators will try to put forward the existing guidelines to further optimization of perioperative anesthesia and analgesia protocol for small-incision thoracic surgery and optimized drainage tube strategy.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016777
  org study id: ChinaJapanFHAnesth2
  nct id: NCT06016777
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Trial design Despite video-assisted thoracic technology and procedure specific postoperative
        pain management (PROSPECT) have been promoted through recent years, thoracic surgery is still
        considered to be one of the most painful of surgical procedures. This study aims to optimize
        these conditions according to different perioperative analgesic modes recommended at present.
        This will be a single-blind randomized study to investigate the optimal analgesic effect of
        thoracic paravertebral block (TPB), erector spinae block (ESB), or sufentanil patient
        controlled intravenous analgesia (PCIA) for uniportal video-assisted thoracoscopic surgery
        (uVATS) and using minimally invasive drainage.
  
        Methods One-hundred and two patients undergoing uVATS will be enrolled. Patients will be
        randomly assigned to PVB group (20mL 0.3% ropivacaine with dexamethasone), ESB group (20mL
        0.3% ropivacaine with dexamethasone) or CON group. PCIA with sufentanil will be provided to
        all patients after surgery. Primary outcome will be total opioid consumption from the end of
        the surgery to the time of discharge. Secondary outcomes consist of postoperative pain score,
        postoperative chronic pain, both at rest and during coughing, sensations of touch and pain on
        the chest wall, non-opioid analgesic drug use, length of stay (LOS), ambulation time, total
        cost of hospitalization and long-term postoperative analgesia. Adverse reaction to analgesics
        and adverse event related to regional block will also be recorded.
  
        Ethics and dissenmination This study is approved by the Ethics Committee of China-Japan
        Friendship Hospital (ID 2022-KY-127-1). The results will be published in peer-reviewed
        journals.
  
        Key words: fast-track; Enhanced Recovery After Surgery; uniportal video-assisted
        thoracoscopic surgery; randomized controlled trial; thoracoscopic; ultrasonic guidance;
        paravertebral block; erector spinal block
  This is a prospective, randomized controlled study. Patients who are scheduled for elective
        uniportal thoracoscopic surgery in our hospital will be enrolled. Patients will be randomly
        assigned to one of the three groups: ultrasound-guided paravertebral block, ultrasound-guided
        erector spinae block, or intravenous patient-controlled analgesia pump group. Different nerve
        block operation schemes will be used in different groups.
  
        In any of the three groups, general anesthesia will be performed according to the standard,
        and multi-mode analgesic treatment will be appied as the combination of NSAIDs analgesics,
        opioid analgesics, and postoperative rescue analgesic treatment. Participants will be
        followed up at 1, 4, 12, 18 hours, on 1, 2, 3, 4, 7 days, and in 1, 2, 3, 4, 6 months after
        surgery. At each follow-up visit, rest and cough pain level will be recorded, and sense of
        touch and pain in the chest will be examined. Additional analgesic treatment will be given if
        necessary.
  
        Comparisons of the postoperative analgesic use, cough and rest pain, ambulation time, length
        of hospital stay, and hospital costs will be made in the three groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This will be a parallel-group, single-blind, randomized controlled trial. Patients are expected to be enrolled in the trial within 8 months. Participants will be randomly assigned to one of the three groups: ultrasound-guided paravertebral block (PVB+PCIA group), ultrasound-guided erector spinae block(ESB+PCIA group) , or intravenous patient-controlled analgesia pump group (PCIA group). Different nerve block operation schemes will be used in different groups.Except for different nerve block schemes, all the participants will have the same methods and choices of medicine for other kinds of rescue analgesia regimens.The participants and the follow-up evaluation doctors are not aware of the group assignment, and the surgeon and anesthesiologist will not know the grouping code until the beginning of the surgery. In this way, the analgesic effect of each subject can be fairly evaluated.
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Patients will be grouped by block randomization method (1:1:1) by a researcher who is unaware of the meaning of the group code. Patients will be stratified by ID numbers with a block of 6. Within each block, random sequences between 0 and 1 are generated. The group code (A, B or C) will be defined as the remainder of the serial number divided by three. The group code will be put in a light-proof envelope. Patients with the envelope will be transferred to the OR, unaware of the group assignment throughout the study. After induction, the anesthesiologist opens the light-proof envelope and get the group code. Group codes will be recorded in the CRF table with the cards destroyed. Only the principal investigator and the anesthesiologists know the intervention represented by the group code. The anesthesiologists will not involve in postoperative follow-ups or data collection. Neither doctors in charge of postoperative follow-ups nor the statisticians will know the specific interventions.
  measure: total opioid consumption
  time frame: up to 6 months, total opioid use from postoperative period till the discontinuation of surgery-related therapy.
  description: total opioid (morphine equivalent/body weight) consumption from the end of the surgery to the time of discharge.
  measure: postoperative pain score assessed by Visual Analogue Scale VAS (1-10)
  time frame: from the time at the end of surgery to 24 weeks after surgery
  description: rest and cough pain
  measure: postoperative pain score assessed by Numeric Rating Scales, NRS (1-10)
  time frame: from the time at the end of surgery to 24 weeks after surgery
  description: rest and cough pain
  measure: sensations of touch on the chest wall
  time frame: from the time at the end of surgery to 24 weeks after surgery
  description: difference in tactile sense on bilateral chest-wall. Tactile sensation and cold sensation will be measured at four points (<3cm near the incision, and on the other side on the symmetrical chest wall, and at the point of bilateral mid-clavicular-costal arch) with an alcohol-stained cotton swab
  measure: non-opioid analgesic drug use
  time frame: from the time at the end of surgery to 24 weeks after surgery
  description: number of patients with long-term (≥3 days) use of non-opioid analgesic drug
  measure: length of stay (LOS)
  time frame: up to 1 month, LOS is the amount of days the patient spends in the hospital, determined by subtracting the date of admission from the date of discharge
  description: days of hospital stay
  measure: ambulation time
  time frame: up to 1 month, ambulation time is the time the patient first ambulated following the surgical procedure
  description: first time of successful activity off bed, the time between the end of surgery to the time of the first successful ambulation
  measure: total cost of hospitalization
  time frame: up to 1 month, total charges settled on the day of discharge
  description: the in-patients costs total cost of hospitalization=medication cost + hospitalization cost + nursing cost + delay compensation
  measure: long-term postoperative analgesia
  time frame: from the time at the end of surgery to 24 weeks after surgery
  description: number of patient who needs long-term postoperative analgesia (≥3 days after discharge)
  arm group label: PVB+PCIA group
  arm group type: Experimental
  arm group label: ESB+PCIA group
  arm group type: Experimental
  arm group label: PCIA group
  arm group type: Active Comparator
  intervention type: Procedure
  intervention name: Ultrasound-guided paraspinal block and patient-controlled intravenous analgesia pump
  description: Patients in this group will receive ultrasound-guided paraspinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour.
  arm group label: PVB+PCIA group
  intervention type: Procedure
  intervention name: Ultrasound-guided erector spinal block and patient-controlled intravenous analgesia pump
  description: Patients in this group will receive ultrasound-guided erector spinal block with 0.3% ropivacaine and 5mg dexamethasone in total of 20mL saline at T5 level on the operative side. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour.
  arm group label: ESB+PCIA group
  intervention type: Procedure
  intervention name: Patient-controlled intravenous analgesia pump
  description: Patients in this group will not receive regional block. Patients in all the groups will be treated with PCIA after surgery. PCIA with sufentanil will be applied to all participants, with background infusion at 1.8μg/hour, and total dosage <5μg/hour.
  arm group label: ESB+PCIA group
  arm group label: PCIA group
  arm group label: PVB+PCIA group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Zhen Rong ZHANG, Doctor
  role: Study Director
  affiliation: China-Japan Friendship Hospital
  last name: Li Fang WANG, Doctor
  phone: +8615011393879
  email: lilythewolf@sina.com
  last name: Zhen Rong ZHANG, Doctor
  phone: +8613811000378
  email: doctor_zzr@126.com
  responsible party type: Principal Investigator
  investigator affiliation: China-Japan Friendship Hospital
  investigator full name: Li Fang Wang
  investigator title: attending doctor
  sharing ipd: Undecided
  ipd description: Security cameras are set up next to both the computer and the cabinet for data storage. The surveillance video will be available only to medical staff and the principal investigator. Access to data will be restricted to authorized personnel, including ethics committee directors, principal investigator and authorized personnel. Access to paper documents as well as electronic data must be registered, with the name of operator and detailed reasons recorded.
  The results and conclusions of our research will be reported to all the participants, research team, and the public in peer-reviewed journal. The investigators will try to put forward the existing guidelines to further optimization of perioperative anesthesia and analgesia protocol for small-incision thoracic surgery and optimized drainage tube strategy.