<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/NCT01691937</url>
  </required_header>
  <id_info>
    <org_study_id>TJMZK20120302</org_study_id>
    <nct_id>NCT01691937</nct_id>
  </id_info>
  <brief_title>Continuous Paravertebral Block on Postoperative Pain After Hepatectomy</brief_title>
  <official_title>Continuous Right Thoracic Paravertebral Block on Postoperative Pain After Right Lobe Hepatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Netherlands: Ministry of Health, Welfare and Sports</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients often experience moderate to severe postoperative pain, especially during the first&#xD;
      hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be used&#xD;
      after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et al.&#xD;
      2005), but the analgesic effect can be limited and undesirable side effects may occur.&#xD;
&#xD;
      A case report described that right thoracic paravertebral block reduced pain and analgesic&#xD;
      requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural&#xD;
      analgesia, thoracic paravertebral block probably carries a much lower risk of spinal&#xD;
      haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist&#xD;
      1998; Karmakar 2001).&#xD;
&#xD;
      We 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 analgesia decreases opioid consumption during the first 24 h after&#xD;
      right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with&#xD;
      sufentanil.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 2</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The cumulative opioid consumption</measure>
    <time_frame>At 24 postoperative hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The pain scores determined by the numeric rating scale (NRS, 0-10)</measure>
    <time_frame>At 1, 4, 8, 16, and 24 hrs after the surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative nausea and vomiting</measure>
    <time_frame>Up to 24 postoperative hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of postoperative respiratory depression</measure>
    <time_frame>Up to 24 postoperative hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative bleeding</measure>
    <time_frame>Up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hospital length of stay</measure>
    <time_frame>Up to 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Right Lobe Hepatectomy</condition>
  <arm_group>
    <arm_group_label>PVB + PCA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo PVB + PCA</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous Paravertebral block with ropivacaine</intervention_name>
    <description>Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.2% ropivacaine is connected to paravertebral catheter, a 10ml bolus of 0.2% ropivacaine is injected via the paravertebral catheter, followed by an infusion of ropivacaine 0.2% at 6 ml/h for postoperative pain management.</description>
    <arm_group_label>PVB + PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Patient-controlled analgesia with sufentanil</intervention_name>
    <description>Once arrival at the PACU, all patients were placed on a postoperative analgesic regimen that included patient-controlled analgesia with intravenous sufentanil (bolus 1μg, lockout time 10 min) and tramadol 100 mg IV for severe pain (NRS 6-10).</description>
    <arm_group_label>PVB + PCA</arm_group_label>
    <arm_group_label>Placebo PVB + PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous Paravertebral Block with Saline</intervention_name>
    <description>Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.9% saline is connected to paravertebral catheter, a 10ml bolus of 0.9% saline is injected via the paravertebral catheter, followed by an infusion of 0.9% saline at 6 ml/h for postoperative pain management.</description>
    <arm_group_label>Placebo PVB + 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 right lobe hepatectomy&#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>
  <overall_official>
    <last_name>Yuke Tian, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>August 12, 2013</last_update_submitted>
  <last_update_submitted_qc>August 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Wei Mei</investigator_full_name>
    <investigator_title>Associate Prof.</investigator_title>
  </responsible_party>
  <keyword>Thoracic paravertebral block</keyword>
  <keyword>Postoperative pain</keyword>
  <keyword>Right lobe hepatectomy</keyword>
  <keyword>Patient controlled analgesia</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>Sufentanil</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/NCT01691937
org study id: TJMZK20120302
nct id: NCT01691937
lead sponsor: 
collaborator: 
has dmc: Yes
Patients often experience moderate to severe postoperative pain, especially during the first
      hours after hepatectomy. Systemic opioids given with patient-controlled analgesia has be used
      after hepatectomy in many medical center(Aubrun, Monsel et al. 2001; Aubrun, Salvi et al.
      2005), but the analgesic effect can be limited and undesirable side effects may occur.

      A case report described that right thoracic paravertebral block reduced pain and analgesic
      requirements after right lobe hepatectomy(Ho, Karmakar et al. 2004). Compared with epidural
      analgesia, thoracic paravertebral block probably carries a much lower risk of spinal
      haematoma in the presence of moderate haemostatic deficiencies (Richardson and Lonnqvist
      1998; Karmakar 2001).

      We therefore designed a prospective, randomized, subject and assessor blinded,
      parallel-group, placebo controlled study to test the hypothesis that continuous right
      thoracic paravertebral analgesia decreases opioid consumption during the first 24 h after
      right lobe hepatectomy in patients receiving i.v. patient-controlled analgesia (PCA) with
      sufentanil.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The cumulative opioid consumption
time frame: At 24 postoperative hours
measure: The pain scores determined by the numeric rating scale (NRS, 0-10)
time frame: At 1, 4, 8, 16, and 24 hrs after the surgery
measure: Incidence of postoperative nausea and vomiting
time frame: Up to 24 postoperative hrs
measure: Incidence of postoperative respiratory depression
time frame: Up to 24 postoperative hrs
measure: Intraoperative bleeding
time frame: Up to 4 hours
measure: Postoperative hospital length of stay
time frame: Up to 6 weeks
arm group label: PVB + PCA
arm group type: Experimental
description: Continuous Paravertebral block with ropivacaine and Patient-controlled analgesia with sufentanil
arm group label: Placebo PVB + PCA
arm group type: Placebo Comparator
description: Continuous Paravertebral Block with Saline and Patient-controlled analgesia with sufentanil
intervention type: Procedure
intervention name: Continuous Paravertebral block with ropivacaine
description: Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.2% ropivacaine is connected to paravertebral catheter, a 10ml bolus of 0.2% ropivacaine is injected via the paravertebral catheter, followed by an infusion of ropivacaine 0.2% at 6 ml/h for postoperative pain management.
arm group label: PVB + PCA
intervention type: Procedure
intervention name: Patient-controlled analgesia with sufentanil
description: Once arrival at the PACU, all patients were placed on a postoperative analgesic regimen that included patient-controlled analgesia with intravenous sufentanil (bolus 1μg, lockout time 10 min) and tramadol 100 mg IV for severe pain (NRS 6-10).
arm group label: PVB + PCA
arm group label: Placebo PVB + PCA
intervention type: Procedure
intervention name: Continuous Paravertebral Block with Saline
description: Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.9% saline is connected to paravertebral catheter, a 10ml bolus of 0.9% saline is injected via the paravertebral catheter, followed by an infusion of 0.9% saline at 6 ml/h for postoperative pain management.
arm group label: Placebo PVB + PCA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yuke Tian, MD.
role: Study Chair
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Wei Mei
investigator title: Associate Prof.
mesh term: Pain, Postoperative
mesh term: Sufentanil
mesh term: Ropivacaine