<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/NCT03777644</url>
  </required_header>
  <id_info>
    <org_study_id>cuixulei7</org_study_id>
    <nct_id>NCT03777644</nct_id>
  </id_info>
  <brief_title>Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy</brief_title>
  <official_title>Effect of Continuous Paravertebral Block on Postoperative Quality of Recovery After Hepatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cui Xulei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</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>
      Moderate to severe postoperative pain often influence patients quality of recovery after&#xD;
      hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after&#xD;
      hepatectomy in many medical center, but the analgesic effect can be limited and undesirable&#xD;
      side effects may bring about negative effects on patients recovery. Regional block has been&#xD;
      proved to improve patients postoperative recovery in many kinds of surgeries.&#xD;
&#xD;
      The investigators therefore designed a prospective, randomized, subject and assessor blinded,&#xD;
      parallel-group, placebo controlled study to test the hypothesis that continuous right&#xD;
      thoracic paravertebral block increase patients quality of recovery score on the 7th&#xD;
      postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia&#xD;
      (PCA) with morphine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">May 19, 2019</completion_date>
  <primary_completion_date type="Actual">May 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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the postoperative recovery quality on postoperative day 7</measure>
    <time_frame>at the 7th postoperative day</time_frame>
    <description>The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The pain scores determined by the numeric rating scale (NRS, 0-10)</measure>
    <time_frame>At 8, 24,48 hours after the surgery</time_frame>
    <description>The patients evaluated their pain severity with thenumeric rating scale (NRS, 0-10),where 0 indicates no pain, and 10 indicates the most severe pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulated morphine consumption</measure>
    <time_frame>At 8, 24,48 hours after the surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post operative length of stay</measure>
    <time_frame>Up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to out-of bed activity/ambutation</measure>
    <time_frame>Up to 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to resumption of bowel movement</measure>
    <time_frame>Up to 2 weeks after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire</measure>
    <time_frame>at the 3th postoperative day</time_frame>
    <description>The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Nerve Block</condition>
  <arm_group>
    <arm_group_label>TPVB + PCA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo TPVB + PCA</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous Paravertebral block with ropivacaine</intervention_name>
    <description>Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.&#xD;
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning&#xD;
Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg</description>
    <arm_group_label>TPVB + PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous Paravertebral Block with Saline</intervention_name>
    <description>Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.&#xD;
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning&#xD;
Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose</description>
    <arm_group_label>placebo TPVB + PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Patient-controlled analgesia with morphine</intervention_name>
    <description>Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg</description>
    <arm_group_label>TPVB + PCA</arm_group_label>
    <arm_group_label>placebo TPVB + PCA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-70 yrs&#xD;
&#xD;
          -  American Society of Anesthesiologists physical statusⅠ-Ⅲ&#xD;
&#xD;
          -  Undergo hepatectomy with J-shape subcostal incision&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A known allergy to the drugs being used&#xD;
&#xD;
          -  Coagulopathy, on anticoagulants&#xD;
&#xD;
          -  Analgesics intake, history of substance abuse&#xD;
&#xD;
          -  Participating in the investigation of another experimental agent&#xD;
&#xD;
          -  Inability to properly describe postoperative pain to investigators (eg, language&#xD;
             barrier, neuropsychiatric disorder)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Cui Xulei</investigator_full_name>
    <investigator_title>attending physician</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03777644
org study id: cuixulei7
nct id: NCT03777644
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Moderate to severe postoperative pain often influence patients quality of recovery after
      hepatectomy. Systemic opioids given with patient-controlled analgesia has been used after
      hepatectomy in many medical center, but the analgesic effect can be limited and undesirable
      side effects may bring about negative effects on patients recovery. Regional block has been
      proved to improve patients postoperative recovery in many kinds of surgeries.

      The investigators therefore designed a prospective, randomized, subject and assessor blinded,
      parallel-group, placebo controlled study to test the hypothesis that continuous right
      thoracic paravertebral block increase patients quality of recovery score on the 7th
      postoperative day after hepatectomy in patients receiving i.v. patient-controlled analgesia
      (PCA) with morphine.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: the postoperative recovery quality on postoperative day 7
time frame: at the 7th postoperative day
description: The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
measure: The pain scores determined by the numeric rating scale (NRS, 0-10)
time frame: At 8, 24,48 hours after the surgery
description: The patients evaluated their pain severity with thenumeric rating scale (NRS, 0-10),where 0 indicates no pain, and 10 indicates the most severe pain.
measure: cumulated morphine consumption
time frame: At 8, 24,48 hours after the surgery
measure: post operative length of stay
time frame: Up to 2 weeks
measure: time to out-of bed activity/ambutation
time frame: Up to 2 weeks
measure: time to resumption of bowel movement
time frame: Up to 2 weeks after surgery
measure: the postoperative recovery quality on postoperative day 3: QoR-15 questionnaire
time frame: at the 3th postoperative day
description: The postoperative recovery quality is evaluated with QoR-15 questionnaire. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (2 items), physical comfort (5 items), physical independence (2 items), psychological support (2 items), and emotional state (4 items) [2 Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR- 15. Anesthesiology. 2013;118(6):1332.]. Each item is scored from 0 to 10, and the possible total score ranges from 0(extremely poor quality of recovery) to 150 (excellent quality of re covery).
arm group label: TPVB + PCA
arm group type: Experimental
description: Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with morphine
arm group label: placebo TPVB + PCA
arm group type: Placebo Comparator
description: Continuous Paravertebral Block with Saline and Patient-controlled analgesia with morphine
intervention type: Procedure
intervention name: Continuous Paravertebral block with ropivacaine
description: Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
arm group label: TPVB + PCA
intervention type: Procedure
intervention name: Continuous Paravertebral Block with Saline
description: Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose
arm group label: placebo TPVB + PCA
intervention type: Drug
intervention name: Patient-controlled analgesia with morphine
description: Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
arm group label: TPVB + PCA
arm group label: placebo TPVB + PCA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Cui Xulei
investigator title: attending physician
mesh term: Morphine
mesh term: Ropivacaine