<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/NCT04438265</url>
  </required_header>
  <id_info>
    <org_study_id>PI20-1770 A.4.2</org_study_id>
    <nct_id>NCT04438265</nct_id>
  </id_info>
  <brief_title>Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment</brief_title>
  <official_title>Quadratus Lumborum Type 2 as Chronic Hip Pain Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Medina del Campo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitaio Getafe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Rio Hortega</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Medina del Campo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of the study is to assess whether the performance of type 2 quadratus&#xD;
      lumborum block produces an improvement in the quality of life of the patient with&#xD;
      osteoarthritis of the hip.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The lumbar square block is an interfascial block of the posterior wall of the abdomen,&#xD;
      initially described for the management of postoperative pain in abdominal surgery due to its&#xD;
      suggested effect on the T7-11 roots. The analgesic efficacy of type 1 lumbar square block&#xD;
      (QL1) in hip surgery was subsequently published. Regarding chronic pain, QL2 has been&#xD;
      successfully performed in posttherniorrhaphy pain or pancreatic cancer.&#xD;
&#xD;
      This quadratus lumborum type 2 is performed in the patients with hip joint based on the&#xD;
      innervation of the hip and taking the role of thoraco-lumbar fascia in the analgesia of these&#xD;
      patients as a reference. The good results obtained in the first 5 patients have led us to&#xD;
      evaluate whether this blockade can indeed be an analgesic alternative in patients with&#xD;
      coxarthrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>relieve chronic hip pain</measure>
    <time_frame>2 months</time_frame>
    <description>The main objective of the study is to assess whether the performance of type 2 lumbar .square block produces an improvement in the quality of life of the patient with osteoarthritis of the hip. The evaluation of the patient will consist of 2 stages. The first of these will consist of the evaluation consultation&#xD;
evaluation with verbal numeric scale (VNS: 0 no dolor-10 the worst pain imaginable ) if patients improve their quality of pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of adverse effects of the block</measure>
    <time_frame>2 months</time_frame>
    <description>find if there is complications (hematome, kidney punction...)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Hip Arthropathy</condition>
  <condition>Chronic Hip Pain</condition>
  <condition>Ultrasound Therapy; Complications</condition>
  <arm_group>
    <arm_group_label>quadratus lumborum</arm_group_label>
    <description>analgesic technique. The evaluation of the patient will consist of 2 stages. The first of these will consist of the evaluation consultation (clinical history, EVN evaluation, WOMAC) and initial treatment (QL2 block). In the second stage, the patient will be followed up with interviews at 3 weeks, 3 and 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Current analgesia , no QL block apply</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>levobupivacaine</intervention_name>
    <description>local anesthetic</description>
    <arm_group_label>quadratus lumborum</arm_group_label>
    <other_name>chirocane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound device</intervention_name>
    <description>scream</description>
    <arm_group_label>quadratus lumborum</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient with coxarthrosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Sign informed consent (Annex 2)&#xD;
&#xD;
          -  Age 18-85 years&#xD;
&#xD;
          -  Cartilage injury (coxarthrosis) hip&#xD;
&#xD;
          -  Illness &lt;1 year of evolution&#xD;
&#xD;
          -  Patients with pain after treatment with physical therapy, exercises, NSAIDs.&#xD;
&#xD;
          -  EVN&gt; 5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the patient&#xD;
&#xD;
          -  Allergy to the drugs used&#xD;
&#xD;
          -  Contraindication for performing the technique&#xD;
&#xD;
          -  Intraarticular treatment in the previous 3 months&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Teresa Fernandez</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Medina del Campo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria Teresa T Fernandez</last_name>
    <phone>637571685</phone>
    <email>maitefm70@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Fernandez</last_name>
    <phone>637571685</phone>
    <email>maitefm70@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>María Teresa Fernandez</name>
      <address>
        <city>Valladolid</city>
        <state>Castilla Y León</state>
        <zip>47008</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>María Teresa Fernandez</last_name>
      <phone>637571685</phone>
      <email>maitefm70@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.</citation>
    <PMID>30386022</PMID>
  </reference>
  <reference>
    <citation>Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.</citation>
    <PMID>27730633</PMID>
  </reference>
  <reference>
    <citation>Fernandez Martin MT, Lopez Alvarez S, Ortigosa Solorzano E. Quadratus lumborum block. New approach for a chronic hip pain. Cases report. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Jan;67(1):44-48. doi: 10.1016/j.redar.2019.10.001. Epub 2019 Nov 22. English, Spanish.</citation>
    <PMID>31767198</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital del Río Hortega</investigator_affiliation>
    <investigator_full_name>María Teresa Fernandez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>chronic hip pain</keyword>
  <keyword>ultrasound therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Levobupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04438265
org study id: PI20-1770 A.4.2
nct id: NCT04438265
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The main objective of the study is to assess whether the performance of type 2 quadratus
      lumborum block produces an improvement in the quality of life of the patient with
      osteoarthritis of the hip.
The lumbar square block is an interfascial block of the posterior wall of the abdomen,
      initially described for the management of postoperative pain in abdominal surgery due to its
      suggested effect on the T7-11 roots. The analgesic efficacy of type 1 lumbar square block
      (QL1) in hip surgery was subsequently published. Regarding chronic pain, QL2 has been
      successfully performed in posttherniorrhaphy pain or pancreatic cancer.

      This quadratus lumborum type 2 is performed in the patients with hip joint based on the
      innervation of the hip and taking the role of thoraco-lumbar fascia in the analgesia of these
      patients as a reference. The good results obtained in the first 5 patients have led us to
      evaluate whether this blockade can indeed be an analgesic alternative in patients with
      coxarthrosis.
observational model: Case-Control
time perspective: Prospective
measure: relieve chronic hip pain
time frame: 2 months
description: The main objective of the study is to assess whether the performance of type 2 lumbar .square block produces an improvement in the quality of life of the patient with osteoarthritis of the hip. The evaluation of the patient will consist of 2 stages. The first of these will consist of the evaluation consultation
evaluation with verbal numeric scale (VNS: 0 no dolor-10 the worst pain imaginable ) if patients improve their quality of pain
measure: rate of adverse effects of the block
time frame: 2 months
description: find if there is complications (hematome, kidney punction...)
arm group label: quadratus lumborum
description: analgesic technique. The evaluation of the patient will consist of 2 stages. The first of these will consist of the evaluation consultation (clinical history, EVN evaluation, WOMAC) and initial treatment (QL2 block). In the second stage, the patient will be followed up with interviews at 3 weeks, 3 and 6 months.
arm group label: Control
description: Current analgesia , no QL block apply
intervention type: Drug
intervention name: levobupivacaine
description: local anesthetic
arm group label: quadratus lumborum
other name: chirocane
intervention type: Device
intervention name: ultrasound device
description: scream
arm group label: quadratus lumborum
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Maria Teresa Fernandez
role: Study Chair
affiliation: Hospital Medina del Campo
last name: Maria Teresa T Fernandez
phone: 637571685
email: maitefm70@hotmail.com
last name: Maria Fernandez
phone: 637571685
email: maitefm70@hotmail.com
facility: 
status: Recruiting
contact: 
country: Spain
citation: Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.
PMID: 30386022
citation: Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.
PMID: 27730633
citation: Fernandez Martin MT, Lopez Alvarez S, Ortigosa Solorzano E. Quadratus lumborum block. New approach for a chronic hip pain. Cases report. Rev Esp Anestesiol Reanim (Engl Ed). 2020 Jan;67(1):44-48. doi: 10.1016/j.redar.2019.10.001. Epub 2019 Nov 22. English, Spanish.
PMID: 31767198
responsible party type: Principal Investigator
investigator affiliation: Hospital del Río Hortega
investigator full name: María Teresa Fernandez
investigator title: Principal Investigator
mesh term: Joint Diseases
mesh term: Levobupivacaine
sharing ipd: No