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/NCT05998954</url>
    </required_header>
    <id_info>
      <org_study_id>XH20230812</org_study_id>
      <nct_id>NCT05998954</nct_id>
    </id_info>
    <brief_title>Comparison Between Quadratus Lumborum and Modified Erector Spinae Plane (QLESP) Block and Suprainguinal Fascia Iliaca Block for Total Hip Arthroplasty</brief_title>
    <official_title>Randomized Comparison Between Quadratus Lumborum and Modified Erector Spinae Plane (QLESP) Block and Suprainguinal Fascia Iliaca Block for Total Hip Arthroplasty</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huazhong University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huazhong University of Science and Technology</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>
        Total hip arthroplasty (THA) is a common surgical procedure aiming to improve mobility and&#xD;
        quality of life in patients suffering from hip pain. Regional analgesia techniques are&#xD;
        critical components of an optimal multimodal analgesia technique for THA, as they have been&#xD;
        shown to improve pain relief as well as reduce opioid requirements. Ultrasound-guided&#xD;
        suprainguinal fascia iliaca (SFI) block has been recommended as a reliable analgesic option&#xD;
        for THA. However, SFI block may lead to decreased motor strength of the surgical limb thereby&#xD;
        hindering postoperative mobilization. Recently, our group has developed a novel transmuscular&#xD;
        quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by&#xD;
        simple operation, high efficiency, and wide dermatomal coverage of sensory block. In this&#xD;
        randomized trial, we aimed to compare ultrasound-guided QLESP with SFI block as a component&#xD;
        of non-opioid analgesic regimen in patients undergoing THA. The primary outcome of the study&#xD;
        was postoperative sufentanil consumption within the initial 24-h postoperative period after&#xD;
        THA. The secondary objectives were to compare pain scores, postoperative quadriceps strength,&#xD;
        the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and&#xD;
        the time to hospital discharge.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 22, 2023</start_date>
    <completion_date type="Anticipated">October 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 20, 2024</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>Single (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, 6, 12, 24, and 48 hours after the surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quadriceps strength</measure>
      <time_frame>At 1, 6, 12, 24, and 48 hours after the surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time to first rescue analgesia</measure>
      <time_frame>Within postoperative 48 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative hospital length of stay</measure>
      <time_frame>Up to 6 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Time to Ambulation</measure>
      <time_frame>Postoperative 48 hours</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Postoperative 48 hours</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patient was turned to the lateral decubitus position with the side to be blocked upward and a low-frequency curved array transducer was placed on the ﬂank cranially to the iliac crest to identify the transverse process of L4, quadratus lumborum muscle, erector spinae muscle, and psoas muscle. The needle was advanced to gently contact the transverse process using an in-plane technique and 15 ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. The needle was subsequently withdrawn and redirected toward the interfascial plane between the quadratus lumborum and the psoas major muscles, where 15 ml of 0.375% ropivacaine was injected with repeated negative aspiration.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Suprainguinal fascia iliaca block (SFI group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>With the patient in the supine position, the ultrasound transducer was placed in a parasagittal orientation over the inguinal ligament, inferior medially to the anterior superior iliac spine. Using real-time ultrasound imaging internal oblique, sartorius and iliacus muscles, covered by the fascia iliacus, were identified. With the needle tip placed beneath the fascia and above the iliacus muscle from caudad-to-cephalad direction (in-plane technique), 30 ml of 0.375% ropivacaine was injected slowly to separate the fascia iliaca from the iliacus muscle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block</intervention_name>
      <description>Fifteen ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. Fifteen ml of 0.375% ropivacaine was subsequently given between the quadratus lumborum and the psoas major muscles.</description>
      <arm_group_label>Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>suprainguinal fascia iliaca block</intervention_name>
      <description>Thirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.</description>
      <arm_group_label>Suprainguinal fascia iliaca block (SFI group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Age 18-65 yrs 2. American Society of Anesthesiologists classification 1-3 3. Body&#xD;
               mass index between 20 and 35 (kg/m2) 4. Undergo elective primary unilateral THA via a&#xD;
               posterolateral approach 5. Informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. A known allergy to the drugs being used 2. Pre-existing neuropsychiatric disorders&#xD;
               or language barrier 3. Analgesics intake, history of substance abuse 4.&#xD;
               Contraindications to peripheral nerve block 5. Acute cerebrovascular disease 6. Severe&#xD;
               liver failure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xi Wu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wuhan Union Hospital, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xi Wu</last_name>
      <phone>15871715431</phone>
      <email>15871715431@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Wuhan Union Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xi Wu</last_name>
        <phone>15871715431</phone>
        <email>15871715431@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Wu X, Yang L. Quadratus Lumborum and modified Erector Spinae Plane (QLESP) block: A single-puncture technique for total hip arthroplasty. J Clin Anesth. 2020 May;61:109643. doi: 10.1016/j.jclinane.2019.109643. Epub 2019 Oct 23. No abstract available.</citation>
      <PMID>31668470</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</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>Xi Wu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05998954
  org study id: XH20230812
  nct id: NCT05998954
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Total hip arthroplasty (THA) is a common surgical procedure aiming to improve mobility and
        quality of life in patients suffering from hip pain. Regional analgesia techniques are
        critical components of an optimal multimodal analgesia technique for THA, as they have been
        shown to improve pain relief as well as reduce opioid requirements. Ultrasound-guided
        suprainguinal fascia iliaca (SFI) block has been recommended as a reliable analgesic option
        for THA. However, SFI block may lead to decreased motor strength of the surgical limb thereby
        hindering postoperative mobilization. Recently, our group has developed a novel transmuscular
        quadratus lumborum and modified erector spinae plane (QLESP) block, which is characterized by
        simple operation, high efficiency, and wide dermatomal coverage of sensory block. In this
        randomized trial, we aimed to compare ultrasound-guided QLESP with SFI block as a component
        of non-opioid analgesic regimen in patients undergoing THA. The primary outcome of the study
        was postoperative sufentanil consumption within the initial 24-h postoperative period after
        THA. The secondary objectives were to compare pain scores, postoperative quadriceps strength,
        the time to first rescue analgesia, opioid-related adverse effects, time to ambulation, and
        the time to hospital discharge.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (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, 6, 12, 24, and 48 hours after the surgery
  measure: Quadriceps strength
  time frame: At 1, 6, 12, 24, and 48 hours after the surgery
  measure: The time to first rescue analgesia
  time frame: Within postoperative 48 hours
  measure: Postoperative hospital length of stay
  time frame: Up to 6 weeks
  measure: The Time to Ambulation
  time frame: Postoperative 48 hours
  measure: Adverse events
  time frame: Postoperative 48 hours
  arm group label: Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group)
  arm group type: Experimental
  description: The patient was turned to the lateral decubitus position with the side to be blocked upward and a low-frequency curved array transducer was placed on the ﬂank cranially to the iliac crest to identify the transverse process of L4, quadratus lumborum muscle, erector spinae muscle, and psoas muscle. The needle was advanced to gently contact the transverse process using an in-plane technique and 15 ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. The needle was subsequently withdrawn and redirected toward the interfascial plane between the quadratus lumborum and the psoas major muscles, where 15 ml of 0.375% ropivacaine was injected with repeated negative aspiration.
  arm group label: Suprainguinal fascia iliaca block (SFI group)
  arm group type: Active Comparator
  description: With the patient in the supine position, the ultrasound transducer was placed in a parasagittal orientation over the inguinal ligament, inferior medially to the anterior superior iliac spine. Using real-time ultrasound imaging internal oblique, sartorius and iliacus muscles, covered by the fascia iliacus, were identified. With the needle tip placed beneath the fascia and above the iliacus muscle from caudad-to-cephalad direction (in-plane technique), 30 ml of 0.375% ropivacaine was injected slowly to separate the fascia iliaca from the iliacus muscle.
  intervention type: Procedure
  intervention name: transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block
  description: Fifteen ml of 0.375% ropivacaine was administered between the erector spinae muscle and the transverse process. Fifteen ml of 0.375% ropivacaine was subsequently given between the quadratus lumborum and the psoas major muscles.
  arm group label: Transmuscular quadratus lumborum and modified erector spinae plane (QLESP) block (QLESP group)
  intervention type: Procedure
  intervention name: suprainguinal fascia iliaca block
  description: Thirty ml of 0.375% ropivacaine will be injected cranial to the inguinal ligament between the fascia iliaca and the iliopsoas muscle.
  arm group label: Suprainguinal fascia iliaca block (SFI group)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Xi Wu
  role: Principal Investigator
  affiliation: Wuhan Union Hospital, China
  last name: Xi Wu
  phone: 15871715431
  email: 15871715431@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Wu X, Yang L. Quadratus Lumborum and modified Erector Spinae Plane (QLESP) block: A single-puncture technique for total hip arthroplasty. J Clin Anesth. 2020 May;61:109643. doi: 10.1016/j.jclinane.2019.109643. Epub 2019 Oct 23. No abstract available.
  PMID: 31668470
  responsible party type: Principal Investigator
  investigator affiliation: Huazhong University of Science and Technology
  investigator full name: Xi Wu
  investigator title: Principal Investigator
  mesh term: Pain, Postoperative
  sharing ipd: No