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/NCT05979493</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY20230830</org_study_id>
      <nct_id>NCT05979493</nct_id>
    </id_info>
    <brief_title>QL Block in Laparoscopic Myomectomy</brief_title>
    <official_title>Quadratus Lumborum Block to Improve Postoperative Pain Management After Laparoscopic Myomectomies: a Double-blinded and Prospective Randomized Clinical Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Joseph Findley MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospitals Cleveland Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</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>
        This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing&#xD;
        postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a&#xD;
        temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back,&#xD;
        that has been previously shown to significantly reduce postoperative pain levels in patients&#xD;
        undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is&#xD;
        becoming a standard of anesthesia and surgical care. Since participants will be undergoing a&#xD;
        myomectomy procedure, the investigators believe that participants may qualify to participate&#xD;
        in this study. The investigators will be comparing patients who receive the QL block (in&#xD;
        addition to standard anesthesia and postoperative pain care) with patients who do not receive&#xD;
        the QL block (in addition to standard care). The participants will be randomly assigned to&#xD;
        one of the two groups and may or may not actually receive the block.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>Phase 4</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>Supportive Care</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Time in minutes from first analgesic request as measured by medical chart review</measure>
      <time_frame>Up to 24 hours</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Total number of doses of rescue analgesics given as measured by medical chart review</measure>
      <time_frame>Up to 24 hours</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain as measured by visual analog scale (VAS)</measure>
      <time_frame>Up to 48 hours after discharge from hospital.</time_frame>
      <description>VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction with perioperative pain management measured on a scale of 1-10</measure>
      <time_frame>Up to 48 hours after discharge from hospital.</time_frame>
      <description>Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pain as measured by Richmond Agitation Sedation Scale (RASS)</measure>
      <time_frame>Up to 24 hours</time_frame>
      <description>RASS is measured from -5 to +4 with -5 being no response to voice or physical stimulation and +4 being overtly combative, violent, immediate danger to staff</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Postoperative Pain</condition>
    <condition>Fibroid Uterus</condition>
    <arm_group>
      <arm_group_label>QL Block with Bupivacaine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacain</intervention_name>
      <description>30cc IM injection in each quadratus lumborum muscle (60cc total).</description>
      <arm_group_label>QL Block with Bupivacaine</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Saline</intervention_name>
      <description>30cc IM injection in each quadratus lumborum muscle (60cc total).</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Presence of uterine fibroids requiring surgical excision with preservation of the&#xD;
               uterus&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pre-existing diagnoses of anxiety or depression&#xD;
  &#xD;
            -  Pre-existing coagulopathies&#xD;
  &#xD;
            -  Pre-existing neuropathic or chronic pelvic pain&#xD;
  &#xD;
            -  Chronic opioid use&#xD;
  &#xD;
            -  Illiteracy due to inability to read and understand plain questionnaire&#xD;
  &#xD;
            -  Non-English speaking&#xD;
  &#xD;
            -  BMI &gt;38&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joseph Findley, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospitals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Catherine P Haering, BA</last_name>
      <phone>3392011531</phone>
      <email>cph43@case.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospitals Ahuja Medical Center</name>
        <address>
          <city>Beachwood</city>
          <state>Ohio</state>
          <zip>44122</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Catherine P Haering, BA</last_name>
        <phone>339-201-1531</phone>
        <email>cph43@case.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University Hospitals Cleveland Medical Center</investigator_affiliation>
      <investigator_full_name>Joseph Findley MD</investigator_full_name>
      <investigator_title>University Hospitals Department of Reproductive Endocrinology and Infertility</investigator_title>
    </responsible_party>
    <keyword>QL Block</keyword>
    <keyword>Myomectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leiomyoma</mesh_term>
      <mesh_term>Myofibroma</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_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/NCT05979493
  org study id: STUDY20230830
  nct id: NCT05979493
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This study aims to determine the efficacy of a quadratus lumborum (QL) block in decreasing
        postoperative pain in patients undergoing myomectomy for uterine fibroids. A QL block is a
        temporary anesthetic injection in the quadratus lumborum muscle, a muscle in the lower back,
        that has been previously shown to significantly reduce postoperative pain levels in patients
        undergoing abdominal and pelvic surgery. Because of its demonstrated effects, the QL block is
        becoming a standard of anesthesia and surgical care. Since participants will be undergoing a
        myomectomy procedure, the investigators believe that participants may qualify to participate
        in this study. The investigators will be comparing patients who receive the QL block (in
        addition to standard anesthesia and postoperative pain care) with patients who do not receive
        the QL block (in addition to standard care). The participants will be randomly assigned to
        one of the two groups and may or may not actually receive the block.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Time in minutes from first analgesic request as measured by medical chart review
  time frame: Up to 24 hours
  measure: Total number of doses of rescue analgesics given as measured by medical chart review
  time frame: Up to 24 hours
  measure: Pain as measured by visual analog scale (VAS)
  time frame: Up to 48 hours after discharge from hospital.
  description: VAS is a pain scale from 0-10 with 0 being no pain and 10 being the worst pain ever.
  measure: Patient satisfaction with perioperative pain management measured on a scale of 1-10
  time frame: Up to 48 hours after discharge from hospital.
  description: Pain management scale with 1 being very disappointed in pain management with 10 being highly satisfied with pain managment.
  measure: Pain as measured by Richmond Agitation Sedation Scale (RASS)
  time frame: Up to 24 hours
  description: RASS is measured from -5 to +4 with -5 being no response to voice or physical stimulation and +4 being overtly combative, violent, immediate danger to staff
  arm group label: QL Block with Bupivacaine
  arm group type: Experimental
  description: Participants will get a QL block using 30cc Bupivacaine bilaterally in quadratus lumborum muscle (60cc total).
  arm group label: Control
  arm group type: Sham Comparator
  description: Participants will get a sham injection of 30cc saline bilaterally in quadratus lumborum muscle (60cc total).
  intervention type: Drug
  intervention name: Bupivacain
  description: 30cc IM injection in each quadratus lumborum muscle (60cc total).
  arm group label: QL Block with Bupivacaine
  intervention type: Drug
  intervention name: Saline
  description: 30cc IM injection in each quadratus lumborum muscle (60cc total).
  arm group label: Control
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: Joseph Findley, MD
  role: Principal Investigator
  affiliation: University Hospitals
  last name: Catherine P Haering, BA
  phone: 3392011531
  email: cph43@case.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: University Hospitals Cleveland Medical Center
  investigator full name: Joseph Findley MD
  investigator title: University Hospitals Department of Reproductive Endocrinology and Infertility
  mesh term: Leiomyoma
  mesh term: Myofibroma
  mesh term: Pain, Postoperative
  mesh term: Bupivacaine
  sharing ipd: No