<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/NCT04480320</url>
  </required_header>
  <id_info>
    <org_study_id>K-2020-085-01</org_study_id>
    <nct_id>NCT04480320</nct_id>
  </id_info>
  <brief_title>Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty</brief_title>
  <acronym>QUASH</acronym>
  <official_title>Sonography-guided Pericapsular Nerve Group Block for Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou First People's 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>
      In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG)&#xD;
      block in hip arthroplasty as a post-operative pain management technique, study the analgesia,&#xD;
      opioid-sparing effects and motor-blocking effects of the PENG block&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PENG Block group (PG) will receive 0.5%Ropivacaine in 20 ml of saline. Sham Block group (SG)&#xD;
      will receive 20 ml of saline Patient will be sedated with IV midazolam before nerve block.&#xD;
      After peripheral nerve block ,general anesthesia will be conducted using sufentanyl, propofol&#xD;
      and rocuronium for induction and propofol and sevoflurane for maintenance. Tests will be&#xD;
      operated after procedure，and recorded up to 48 hours after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</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>
  </study_design_info>
  <primary_outcome>
    <measure>Highest VAS score in recovery room</measure>
    <time_frame>before recovery room discharge(up to 2 hours after surgery end)</time_frame>
    <description>Highest VAS score reported in recovery room,patient will be asked questions to measure the highest VAS score experienced in the recovery room before discharge. If the patient had a unexpected long stay at recovery room, the question will be asked at the time point &quot;2 hours after surgery end&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VAS at rest</measure>
    <time_frame>day0 ,day1 ,day2</time_frame>
    <description>VAS pain score while patient at rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>highest VAS at period</measure>
    <time_frame>day0 ,day1 ,day2</time_frame>
    <description>highest VAS reported at follow up period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quadriceps strength</measure>
    <time_frame>day0 , day1 ,day2</time_frame>
    <description>Measure quadriceps strength peak value at different time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total opioid consumption</measure>
    <time_frame>up to 2 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PONV rate</measure>
    <time_frame>day0 ,day1 ,day2</time_frame>
    <description>postoperative nausea and vomit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fall incident happened</measure>
    <time_frame>up to 2 days after surgery</time_frame>
    <description>Record the fall incident happened,fall is defined as patinent accidently fall to the ground.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nerve block range</measure>
    <time_frame>day0 , before discharge from PACU(up to 2 hours after surgery end)</time_frame>
    <description>A cotton yarn with ethanol will be put on both the surgical and nonsurgical leg to evaluate the cold sensation lost after nerve block.Skin sensation lost will be tested at lateral thigh,medial thigh,front thigh and lateral claf</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">71</enrollment>
  <condition>Arthroplasty</condition>
  <condition>Nerve Block</condition>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Pericapsular nerve group block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pericapsular nerve group block</intervention_name>
    <description>Branches of both the FN and ON provide innervation to the anterior hip capsule. High and low branches of FN provided the majority of innervation to the lateral and superomedial hip capsule. The AON innervates the medial capsule.Both of the nerve close to the periosteum between the iliopubic eminence and AIIS ,by using ultrasound guided technique,these sites can be potential bony landmarks provid approch to the nerve group.</description>
    <arm_group_label>Pericapsular nerve group block</arm_group_label>
    <arm_group_label>Saline placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for hip arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to local anesthetics&#xD;
&#xD;
          -  infection at the injection site&#xD;
&#xD;
          -  patients receiving opioids for chronic analgesic therapy&#xD;
&#xD;
          -  other lower limb neuropathies&#xD;
&#xD;
          -  inability to comprehend visual analog scale (VAS)&#xD;
&#xD;
          -  preexist cognitive dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Guangzhou First Municipal People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangcai Ruan, MD, PHD</last_name>
      <phone>8620-81048306</phone>
      <email>xc_ruan@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Jun Zheng, MD, Msc</last_name>
      <email>zhengjun19861029@126.com</email>
    </contact_backup>
    <investigator>
      <last_name>Xiangcai Ruan, MD, PHD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jun Zheng, MD, Msc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou First People's Hospital</investigator_affiliation>
    <investigator_full_name>Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth &amp; Pain</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Pericapsular Nerve Group</keyword>
  <keyword>PENG</keyword>
  <keyword>hip arthroplasty</keyword>
  <keyword>Postoperative analgesia</keyword>
  <keyword>quadriceps strength</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04480320
org study id: K-2020-085-01
nct id: NCT04480320
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG)
      block in hip arthroplasty as a post-operative pain management technique, study the analgesia,
      opioid-sparing effects and motor-blocking effects of the PENG block
PENG Block group (PG) will receive 0.5%Ropivacaine in 20 ml of saline. Sham Block group (SG)
      will receive 20 ml of saline Patient will be sedated with IV midazolam before nerve block.
      After peripheral nerve block ,general anesthesia will be conducted using sufentanyl, propofol
      and rocuronium for induction and propofol and sevoflurane for maintenance. Tests will be
      operated after procedure，and recorded up to 48 hours after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Highest VAS score in recovery room
time frame: before recovery room discharge(up to 2 hours after surgery end)
description: Highest VAS score reported in recovery room,patient will be asked questions to measure the highest VAS score experienced in the recovery room before discharge. If the patient had a unexpected long stay at recovery room, the question will be asked at the time point "2 hours after surgery end"
measure: VAS at rest
time frame: day0 ,day1 ,day2
description: VAS pain score while patient at rest
measure: highest VAS at period
time frame: day0 ,day1 ,day2
description: highest VAS reported at follow up period
measure: quadriceps strength
time frame: day0 , day1 ,day2
description: Measure quadriceps strength peak value at different time point
measure: total opioid consumption
time frame: up to 2 days after surgery
measure: PONV rate
time frame: day0 ,day1 ,day2
description: postoperative nausea and vomit
measure: Fall incident happened
time frame: up to 2 days after surgery
description: Record the fall incident happened,fall is defined as patinent accidently fall to the ground.
measure: Nerve block range
time frame: day0 , before discharge from PACU(up to 2 hours after surgery end)
description: A cotton yarn with ethanol will be put on both the surgical and nonsurgical leg to evaluate the cold sensation lost after nerve block.Skin sensation lost will be tested at lateral thigh,medial thigh,front thigh and lateral claf
arm group label: Pericapsular nerve group block
arm group type: Experimental
arm group label: Saline placebo group
arm group type: Placebo Comparator
intervention type: Procedure
intervention name: pericapsular nerve group block
description: Branches of both the FN and ON provide innervation to the anterior hip capsule. High and low branches of FN provided the majority of innervation to the lateral and superomedial hip capsule. The AON innervates the medial capsule.Both of the nerve close to the periosteum between the iliopubic eminence and AIIS ,by using ultrasound guided technique,these sites can be potential bony landmarks provid approch to the nerve group.
arm group label: Pericapsular nerve group block
arm group label: Saline placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guangzhou First People's Hospital
investigator full name: Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain
investigator title: Professor
sharing ipd: Undecided