<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/NCT03771742</url>
  </required_header>
  <id_info>
    <org_study_id>cuixule6</org_study_id>
    <nct_id>NCT03771742</nct_id>
  </id_info>
  <brief_title>Modified Paramedic Sagittal vs. Transverse TMQLB</brief_title>
  <official_title>Randomized Prospective Study to Evaluate Cranial Dermatomal Spread of Modified Paramedic Sagittal Versus Transverse Approach TMQLB for Adrenal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College 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>
      The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to&#xD;
      provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local&#xD;
      anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan,&#xD;
      posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB)&#xD;
      approach has been introduced to facilitate cranial spread by injecting the local in a caudal&#xD;
      to cranial direction. Currently, there are no data comparing the two techniques mentioned&#xD;
      above with regards to extent of spread for PVS. Our objective is to investigate the extent of&#xD;
      cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected&#xD;
      with the transverse versus an modified paramedian sagittal approach for patients undergoing&#xD;
      laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance&#xD;
      time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2018</start_date>
  <completion_date type="Actual">February 17, 2019</completion_date>
  <primary_completion_date type="Actual">February 14, 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>Other</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cephalic sensory dermatomal spread</measure>
    <time_frame>20 minutes after block performance</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to performance of procedure</measure>
    <time_frame>Duration of procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total sensory dermatomal spread</measure>
    <time_frame>20 minutes after block performance</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complication</measure>
    <time_frame>Within 48hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caudal sensory dermatomal spread</measure>
    <time_frame>20 minutes after block performance</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative rate of rescue analgesics usage</measure>
    <time_frame>At 0,2,4,8,12,24,48 hours after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS pain scores</measure>
    <time_frame>At 0,2,4,8,12,24,48hours after surgery</time_frame>
    <description>patients will evaluate their pain intensity with the numerical rating scale (NRS), where 0 indicates no pain, and 10 indicates the most severe pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Nerve Block</condition>
  <arm_group>
    <arm_group_label>transverse TMQLB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>paramedian sagittal TMQLB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the para-sagittal scan, in-plain, caudal to cephalic approach.0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>transverse scan, in-plane, posterior-anterior TMQLB</intervention_name>
    <description>The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.</description>
    <arm_group_label>transverse TMQLB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>paramedian sagittal scan, in-plane, caudal-cranial TMQLB</intervention_name>
    <description>The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the paramedic sagittal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.</description>
    <arm_group_label>paramedian sagittal TMQLB</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 laparoscopic adrenalectomy&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Able to cooperate with study process&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to local anesthetic and other medications used in the study&#xD;
&#xD;
          -  Patient refusal or lack of informed consent&#xD;
&#xD;
          -  Coexisting hematological disorder or with deranged coagulation parameters&#xD;
&#xD;
          -  Pre-existing major organ dysfunction such as hepatic and renal failure&#xD;
&#xD;
          -  History of previous renal surgery.&#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>Xulei CUI</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <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>April 2019</verification_date>
  <study_first_submitted>December 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>
  <!-- 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/NCT03771742
org study id: cuixule6
nct id: NCT03771742
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to
      provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local
      anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan,
      posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB)
      approach has been introduced to facilitate cranial spread by injecting the local in a caudal
      to cranial direction. Currently, there are no data comparing the two techniques mentioned
      above with regards to extent of spread for PVS. Our objective is to investigate the extent of
      cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected
      with the transverse versus an modified paramedian sagittal approach for patients undergoing
      laparoscopic adrenalectomy. In addition, the investigators wish to compare the performance
      time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Cephalic sensory dermatomal spread
time frame: 20 minutes after block performance
measure: Time to performance of procedure
time frame: Duration of procedure
measure: Total sensory dermatomal spread
time frame: 20 minutes after block performance
measure: Incidence of complication
time frame: Within 48hours after surgery
measure: Caudal sensory dermatomal spread
time frame: 20 minutes after block performance
measure: cumulative rate of rescue analgesics usage
time frame: At 0,2,4,8,12,24,48 hours after surgery
measure: NRS pain scores
time frame: At 0,2,4,8,12,24,48hours after surgery
description: patients will evaluate their pain intensity with the numerical rating scale (NRS), where 0 indicates no pain, and 10 indicates the most severe pain.
arm group label: transverse TMQLB
arm group type: Active Comparator
description: Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed.
arm group label: paramedian sagittal TMQLB
arm group type: Experimental
description: Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the para-sagittal scan, in-plain, caudal to cephalic approach.0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed.
intervention type: Procedure
intervention name: transverse scan, in-plane, posterior-anterior TMQLB
description: The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.
arm group label: transverse TMQLB
intervention type: Procedure
intervention name: paramedian sagittal scan, in-plane, caudal-cranial TMQLB
description: The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the paramedic sagittal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.
arm group label: paramedian sagittal TMQLB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Xulei CUI
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Cui Xulei
investigator title: Attending physician