<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/NCT03801265</url>
  </required_header>
  <id_info>
    <org_study_id>PRO18120275</org_study_id>
    <nct_id>NCT03801265</nct_id>
  </id_info>
  <brief_title>Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement</brief_title>
  <official_title>A Prospective, Randomized, Double-blinded, Active-comparator, Non-inferiority Study to Observe Relative Efficacy of Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Class Lumbar Plexus Block in Managing Post-operative Pain Following Total Hip Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sharad Khetarpal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</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>
      The Lumbar Plexus (LP) block is currently used as the standard-of-care regional anesthesia&#xD;
      technique to provide postoperative pain management after primary hip replacement surgery at&#xD;
      UPMC Shadyside Hospital. However, the LP technique is complex and can be associated with&#xD;
      potentially serious side effects, including nerve injury, major bleeding, retroperitoneal&#xD;
      hematoma, and intrathecal injection of local anesthetic. In rare instances the LP block can&#xD;
      also lead to motor blockade, interfering with early ambulation. There are several case&#xD;
      reports of Quadratus Lumborum inter-fascial block (QL3) giving equally adequate pain relief&#xD;
      after total hip replacement surgery, and this QL3 block is performed routinely at this&#xD;
      institution. The benefits to inter-fascial administration of local anesthetic include the&#xD;
      avoidance of theoretical nerve injury, bleeding and intrathecal anesthetic administration&#xD;
      associated with the direct interaction between the nerve and the nerve block needle. The&#xD;
      purpose of this study is to show that QL3 block is non-inferior to the standard-of-care&#xD;
      lumbar plexus block and should be used more regularly in hip replacement surgery. The study&#xD;
      will be conducted as a prospective, randomized (1:1), double-blind, non-inferiority,&#xD;
      active-comparator trial. The investigators plan to enroll 40 subjects, 20 in each treatment&#xD;
      group. This study will prospectively investigate the efficacy of QL3 versus Classic LP block&#xD;
      for post-operative pain management in subjects undergoing primary, unilateral hip replacement&#xD;
      surgery and prospectively compare QL3 versus Classic LP block in time to mobilization and&#xD;
      physical therapy response. Primary outcome measures include pain at rest and with movement at&#xD;
      6, 12 and 24 hours after surgery. Secondary outcomes will be time for first request for pain&#xD;
      medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours&#xD;
      and the time of participant's ability to walk 100 feet as recorded by a physical therapist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be approached for the study by the PI or Sub-I in the pre-operative&#xD;
      area on their day of surgery. The anesthesiology investigator will speak with the patient&#xD;
      about the study behind a closed drape and the patient will have adequate time to consider the&#xD;
      consent and ask questions regarding risk factors associated with each type of block. Once&#xD;
      consented, the patient will be randomized by computer generated random number to one of the&#xD;
      two treatment groups. Once assigned the treatment allocation, only the clinician&#xD;
      administering the block will be unblinded to the randomization outcome. If randomized to the&#xD;
      LP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS)&#xD;
      will administer the block with this approach: Patient will be positioned in lateral decubitus&#xD;
      position with side to be blocked facing upwards. Midline will be identified by palpating the&#xD;
      spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle&#xD;
      insertion will be 4 cm lateral to the intersection of both lines. The transverse process will&#xD;
      first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be&#xD;
      used and advanced until it contacted the transverse process. Needle will then be redirected&#xD;
      cephalad or caudad and advanced 1 cm, until the quadriceps femoris twitch is obtained. Local&#xD;
      anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli&#xD;
      amperes.If randomized to the QL3 block, an anesthesiologist on the Acute Interventional&#xD;
      Perioperative Pain Service (AIPPS) will administer the block with this approach:Patient will&#xD;
      be placed in a lateral position with the side to be blocked facing up. A low frequency&#xD;
      transducer will be used to identify three layers of abdominal musculature, probe will be then&#xD;
      moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is&#xD;
      then identified by tracing the aponeurosis posteriorly. The transducer is then moved more&#xD;
      posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas&#xD;
      muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in&#xD;
      plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane&#xD;
      between QL and psoas major and local anesthetic is deposited. For both treatment groups, the&#xD;
      local anesthetic used will be 100 mg 0.5% ropivacaine. After surgery, the patient will be&#xD;
      followed by the blinded research team for incidence of adverse events, as well as the&#xD;
      collection of the primary outcome measures. These include pain at rest and with movement at&#xD;
      6, 12 and 24 hours after surgery, time for first request for pain medication, total pain&#xD;
      medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of&#xD;
      participant's ability to walk 100 feet as recorded by physical therapist. This information&#xD;
      will be captured from the patient's electronic medical record.&#xD;
&#xD;
      Minor changes were made to the outcome measures after the original approval of this&#xD;
      submission. This was only to clarify the specific measures from the more general descriptions&#xD;
      in the original.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 19, 2019</start_date>
  <completion_date type="Actual">May 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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>
    <intervention_model_description>Lumbar plexus block vs Quadratus lumborum type 3 block</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The person who perform the block will be unblinded. The participants and the outcomes assessor will be blinded to the treatment allocations.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pain at Rest After Surgery</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain With Movement After Surgery</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain at Rest After Surgery</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain With Movement After Surgery</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain at Rest After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain With Movement After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain During Physical Therapy</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Opioid Consumption During 24 Hours After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Narcotics will be converted to oral morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Time to Accomplish Walking 100 Feet</measure>
    <time_frame>within 24 hours after surgery</time_frame>
    <description>This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Block Procedure Duration</measure>
    <time_frame>during surgery</time_frame>
    <description>Duration that the patient underwent the block procedure during surgery in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients With Postoperative Quadriceps Weakness</measure>
    <time_frame>12 hours after surgery</time_frame>
    <description>patients who report having post-surgical quadriceps weakness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Acetaminophen Consumption During 24 Hours After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Celecoxib Consumption During 24 Hours After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Ketorolac Consumption During 24 Hours After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Gabapentin Consumption During 24 Hours After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Oral Ketamine Consumption During 24 Hours After Surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption During 0-6 Hours After Surgery</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Narcotics will be converted to oral morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption During 6-12 Hours After Surgery</measure>
    <time_frame>6-12 hours after surgery</time_frame>
    <description>Narcotics will be converted to oral morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Consumption During 12-24 Hours After Surgery</measure>
    <time_frame>12-24 hours after surgery</time_frame>
    <description>Narcotics will be converted to oral morphine equivalents</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Hip Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Lumbar Plexus block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.5% ropivacaine 100 mg (20 ml) will be injected</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadratus Lumborum type 3 block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5% ropivacaine 100 mg (20 ml) will be injected</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lumbar plexus block</intervention_name>
    <description>Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.</description>
    <arm_group_label>Lumbar Plexus block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quadratus lumborum type 3 block</intervention_name>
    <description>Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.</description>
    <arm_group_label>Quadratus Lumborum type 3 block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine injection</intervention_name>
    <description>0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
    <arm_group_label>Lumbar Plexus block</arm_group_label>
    <arm_group_label>Quadratus Lumborum type 3 block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18-90 years old&#xD;
&#xD;
          2. Primary unilateral total hip arthroplasty&#xD;
&#xD;
          3. BMI 20 - 36&#xD;
&#xD;
          4. Male and Female&#xD;
&#xD;
          5. All races&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient refusal&#xD;
&#xD;
          2. ASA class &gt; or = 4&#xD;
&#xD;
          3. Pregnancy&#xD;
&#xD;
          4. Any condition precluding patient going home with in 24 hours of surgery&#xD;
&#xD;
          5. Non-English speaking or inability to participate in the study&#xD;
&#xD;
          6. Patients with coagulopathy or on therapeutic anticoagulation&#xD;
&#xD;
          7. Chronic Steroid Use&#xD;
&#xD;
          8. Narcotic Addiction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharad Khetarpal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Presbyterian-Shadyside Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.</citation>
    <PMID>18719448</PMID>
  </reference>
  <reference>
    <citation>Weller RS, Gerancher JC, Crews JC, Wade KL. Extensive retroperitoneal hematoma without neurologic deficit in two patients who underwent lumbar plexus block and were later anticoagulated. Anesthesiology. 2003 Feb;98(2):581-5. doi: 10.1097/00000542-200302000-00044. No abstract available.</citation>
    <PMID>12552223</PMID>
  </reference>
  <reference>
    <citation>Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.</citation>
    <PMID>20889937</PMID>
  </reference>
  <reference>
    <citation>Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.</citation>
    <PMID>27513972</PMID>
  </reference>
  <reference>
    <citation>La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.</citation>
    <PMID>28036319</PMID>
  </reference>
  <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>Børglum J, Moriggl B, Jensen K, Lønnqvist P, Christensen AF, Sauter A, Bendtsen TF. Ultrasound-guided transmuscular quadratus lumborum blockade. British Journal of Anaesthesia 111:eLetters Supplement, 2013.</citation>
  </reference>
  <reference>
    <citation>Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11</citation>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <results_first_submitted>May 30, 2021</results_first_submitted>
  <results_first_submitted_qc>June 24, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">July 15, 2021</results_first_posted>
  <last_update_submitted>June 24, 2021</last_update_submitted>
  <last_update_submitted_qc>June 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Sharad Khetarpal</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>lumbar plexus block</keyword>
  <keyword>quadratus lumborum block</keyword>
  <keyword>total hip arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03801265/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT03801265/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Lumbar Plexus Block</title>
          <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
        </group>
        <group group_id="P2">
          <title>Quadratus Lumborum Type 3 Block</title>
          <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lumbar Plexus Block</title>
          <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
        </group>
        <group group_id="B2">
          <title>Quadratus Lumborum Type 3 Block</title>
          <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="23"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.7" spread="9.8"/>
                    <measurement group_id="B2" value="68.6" spread="11.8"/>
                    <measurement group_id="B3" value="67.1" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain at Rest After Surgery</title>
        <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
        <time_frame>6 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain at Rest After Surgery</title>
          <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="3.0"/>
                    <measurement group_id="O2" value="3.6" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.770</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain With Movement After Surgery</title>
        <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
        <time_frame>6 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain With Movement After Surgery</title>
          <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="3.2"/>
                    <measurement group_id="O2" value="4.7" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.826</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain at Rest After Surgery</title>
        <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
        <time_frame>12 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain at Rest After Surgery</title>
          <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.9"/>
                    <measurement group_id="O2" value="2.8" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.859</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain With Movement After Surgery</title>
        <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
        <time_frame>12 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain With Movement After Surgery</title>
          <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="2.8"/>
                    <measurement group_id="O2" value="4.6" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.904</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain at Rest After Surgery</title>
        <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain at Rest After Surgery</title>
          <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="2.6"/>
                    <measurement group_id="O2" value="1.8" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.122</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain With Movement After Surgery</title>
        <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain With Movement After Surgery</title>
          <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.8"/>
                    <measurement group_id="O2" value="4.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.379</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain During Physical Therapy</title>
        <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain During Physical Therapy</title>
          <description>Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.3" spread="2.5"/>
                    <measurement group_id="O2" value="4.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.881</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Opioid Consumption During 24 Hours After Surgery</title>
        <description>Narcotics will be converted to oral morphine equivalents</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Consumption During 24 Hours After Surgery</title>
          <description>Narcotics will be converted to oral morphine equivalents</description>
          <units>mg oral morphine equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="9.3"/>
                    <measurement group_id="O2" value="14.7" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.818</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Time to Accomplish Walking 100 Feet</title>
        <description>This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.</description>
        <time_frame>within 24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Time to Accomplish Walking 100 Feet</title>
          <description>This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1449.1" spread="760.7"/>
                    <measurement group_id="O2" value="1358.3" spread="715.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.678</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Block Procedure Duration</title>
        <description>Duration that the patient underwent the block procedure during surgery in minutes</description>
        <time_frame>during surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Block Procedure Duration</title>
          <description>Duration that the patient underwent the block procedure during surgery in minutes</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="6.1"/>
                    <measurement group_id="O2" value="6.6" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.002</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients With Postoperative Quadriceps Weakness</title>
        <description>patients who report having post-surgical quadriceps weakness.</description>
        <time_frame>12 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients With Postoperative Quadriceps Weakness</title>
          <description>patients who report having post-surgical quadriceps weakness.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.007</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Acetaminophen Consumption During 24 Hours After Surgery</title>
        <description>Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Acetaminophen Consumption During 24 Hours After Surgery</title>
          <description>Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)</description>
          <units>milligrams (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2782.6" spread="902.3"/>
                    <measurement group_id="O2" value="3087.0" spread="949.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.271</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Celecoxib Consumption During 24 Hours After Surgery</title>
        <description>Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Celecoxib Consumption During 24 Hours After Surgery</title>
          <description>Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)</description>
          <units>milligrams (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191.3" spread="185.7"/>
                    <measurement group_id="O2" value="178.3" spread="180.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.810</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Ketorolac Consumption During 24 Hours After Surgery</title>
        <description>Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Ketorolac Consumption During 24 Hours After Surgery</title>
          <description>Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)</description>
          <units>milligrams (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="17.3"/>
                    <measurement group_id="O2" value="12.4" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.676</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Gabapentin Consumption During 24 Hours After Surgery</title>
        <description>Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Gabapentin Consumption During 24 Hours After Surgery</title>
          <description>Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)</description>
          <units>milligrams (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="382.6" spread="238.7"/>
                    <measurement group_id="O2" value="395.7" spread="481.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.908</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Oral Ketamine Consumption During 24 Hours After Surgery</title>
        <description>Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)</description>
        <time_frame>24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Oral Ketamine Consumption During 24 Hours After Surgery</title>
          <description>Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)</description>
          <units>milligrams (mg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="12.5"/>
                    <measurement group_id="O2" value="13.5" spread="22.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.270</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption During 0-6 Hours After Surgery</title>
        <description>Narcotics will be converted to oral morphine equivalents</description>
        <time_frame>6 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption During 0-6 Hours After Surgery</title>
          <description>Narcotics will be converted to oral morphine equivalents</description>
          <units>mg oral morphine equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="3.2"/>
                    <measurement group_id="O2" value="6.3" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.015</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption During 6-12 Hours After Surgery</title>
        <description>Narcotics will be converted to oral morphine equivalents</description>
        <time_frame>6-12 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption During 6-12 Hours After Surgery</title>
          <description>Narcotics will be converted to oral morphine equivalents</description>
          <units>mg oral morphine equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="4.2"/>
                    <measurement group_id="O2" value="3.4" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.203</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Consumption During 12-24 Hours After Surgery</title>
        <description>Narcotics will be converted to oral morphine equivalents</description>
        <time_frame>12-24 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lumbar Plexus Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
          <group group_id="O2">
            <title>Quadratus Lumborum Type 3 Block</title>
            <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Consumption During 12-24 Hours After Surgery</title>
          <description>Narcotics will be converted to oral morphine equivalents</description>
          <units>mg oral morphine equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="4.6"/>
                    <measurement group_id="O2" value="5.0" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The margin of non-inferiority is 0.5. The true difference between the means is assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software (2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).</non_inferiority_desc>
            <p_value>.672</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>24 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Lumbar Plexus Block</title>
          <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Lumbar plexus block: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
        </group>
        <group group_id="E2">
          <title>Quadratus Lumborum Type 3 Block</title>
          <description>0.5% ropivacaine 100 mg (20 ml) will be injected&#xD;
Quadratus lumborum type 3 block: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.&#xD;
Ropivacaine injection: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was conducted at a single-center, potentially confounding external validity. Though the desired statistical power was achieved, our sample was still small. More non-inferiority studies are needed to confirm our results.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Sharad Khetarpal, MD</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>4126235020</phone>
      <email>khetarpalsk@upmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03801265
org study id: PRO18120275
nct id: NCT03801265
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The Lumbar Plexus (LP) block is currently used as the standard-of-care regional anesthesia
      technique to provide postoperative pain management after primary hip replacement surgery at
      UPMC Shadyside Hospital. However, the LP technique is complex and can be associated with
      potentially serious side effects, including nerve injury, major bleeding, retroperitoneal
      hematoma, and intrathecal injection of local anesthetic. In rare instances the LP block can
      also lead to motor blockade, interfering with early ambulation. There are several case
      reports of Quadratus Lumborum inter-fascial block (QL3) giving equally adequate pain relief
      after total hip replacement surgery, and this QL3 block is performed routinely at this
      institution. The benefits to inter-fascial administration of local anesthetic include the
      avoidance of theoretical nerve injury, bleeding and intrathecal anesthetic administration
      associated with the direct interaction between the nerve and the nerve block needle. The
      purpose of this study is to show that QL3 block is non-inferior to the standard-of-care
      lumbar plexus block and should be used more regularly in hip replacement surgery. The study
      will be conducted as a prospective, randomized (1:1), double-blind, non-inferiority,
      active-comparator trial. The investigators plan to enroll 40 subjects, 20 in each treatment
      group. This study will prospectively investigate the efficacy of QL3 versus Classic LP block
      for post-operative pain management in subjects undergoing primary, unilateral hip replacement
      surgery and prospectively compare QL3 versus Classic LP block in time to mobilization and
      physical therapy response. Primary outcome measures include pain at rest and with movement at
      6, 12 and 24 hours after surgery. Secondary outcomes will be time for first request for pain
      medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours
      and the time of participant's ability to walk 100 feet as recorded by a physical therapist.
Eligible patients will be approached for the study by the PI or Sub-I in the pre-operative
      area on their day of surgery. The anesthesiology investigator will speak with the patient
      about the study behind a closed drape and the patient will have adequate time to consider the
      consent and ask questions regarding risk factors associated with each type of block. Once
      consented, the patient will be randomized by computer generated random number to one of the
      two treatment groups. Once assigned the treatment allocation, only the clinician
      administering the block will be unblinded to the randomization outcome. If randomized to the
      LP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS)
      will administer the block with this approach: Patient will be positioned in lateral decubitus
      position with side to be blocked facing upwards. Midline will be identified by palpating the
      spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle
      insertion will be 4 cm lateral to the intersection of both lines. The transverse process will
      first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be
      used and advanced until it contacted the transverse process. Needle will then be redirected
      cephalad or caudad and advanced 1 cm, until the quadriceps femoris twitch is obtained. Local
      anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli
      amperes.If randomized to the QL3 block, an anesthesiologist on the Acute Interventional
      Perioperative Pain Service (AIPPS) will administer the block with this approach:Patient will
      be placed in a lateral position with the side to be blocked facing up. A low frequency
      transducer will be used to identify three layers of abdominal musculature, probe will be then
      moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is
      then identified by tracing the aponeurosis posteriorly. The transducer is then moved more
      posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas
      muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in
      plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane
      between QL and psoas major and local anesthetic is deposited. For both treatment groups, the
      local anesthetic used will be 100 mg 0.5% ropivacaine. After surgery, the patient will be
      followed by the blinded research team for incidence of adverse events, as well as the
      collection of the primary outcome measures. These include pain at rest and with movement at
      6, 12 and 24 hours after surgery, time for first request for pain medication, total pain
      medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of
      participant's ability to walk 100 feet as recorded by physical therapist. This information
      will be captured from the patient's electronic medical record.

      Minor changes were made to the outcome measures after the original approval of this
      submission. This was only to clarify the specific measures from the more general descriptions
      in the original.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Lumbar plexus block vs Quadratus lumborum type 3 block
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The person who perform the block will be unblinded. The participants and the outcomes assessor will be blinded to the treatment allocations.
measure: Pain at Rest After Surgery
time frame: 6 hours after surgery
description: Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.
measure: Pain With Movement After Surgery
time frame: 6 hours after surgery
description: Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.
measure: Pain at Rest After Surgery
time frame: 12 hours after surgery
description: Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.
measure: Pain With Movement After Surgery
time frame: 12 hours after surgery
description: Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.
measure: Pain at Rest After Surgery
time frame: 24 hours after surgery
description: Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.
measure: Pain With Movement After Surgery
time frame: 24 hours after surgery
description: Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.
measure: Pain During Physical Therapy
time frame: 24 hours after surgery
description: Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.
measure: Total Opioid Consumption During 24 Hours After Surgery
time frame: 24 hours after surgery
description: Narcotics will be converted to oral morphine equivalents
measure: Postoperative Time to Accomplish Walking 100 Feet
time frame: within 24 hours after surgery
description: This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.
measure: Block Procedure Duration
time frame: during surgery
description: Duration that the patient underwent the block procedure during surgery in minutes
measure: Patients With Postoperative Quadriceps Weakness
time frame: 12 hours after surgery
description: patients who report having post-surgical quadriceps weakness.
measure: Total Acetaminophen Consumption During 24 Hours After Surgery
time frame: 24 hours after surgery
description: Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)
measure: Total Celecoxib Consumption During 24 Hours After Surgery
time frame: 24 hours after surgery
description: Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)
measure: Total Ketorolac Consumption During 24 Hours After Surgery
time frame: 24 hours after surgery
description: Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)
measure: Total Gabapentin Consumption During 24 Hours After Surgery
time frame: 24 hours after surgery
description: Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)
measure: Total Oral Ketamine Consumption During 24 Hours After Surgery
time frame: 24 hours after surgery
description: Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)
measure: Opioid Consumption During 0-6 Hours After Surgery
time frame: 6 hours after surgery
description: Narcotics will be converted to oral morphine equivalents
measure: Opioid Consumption During 6-12 Hours After Surgery
time frame: 6-12 hours after surgery
description: Narcotics will be converted to oral morphine equivalents
measure: Opioid Consumption During 12-24 Hours After Surgery
time frame: 12-24 hours after surgery
description: Narcotics will be converted to oral morphine equivalents
arm group label: Lumbar Plexus block
arm group type: Active Comparator
description: 0.5% ropivacaine 100 mg (20 ml) will be injected
arm group label: Quadratus Lumborum type 3 block
arm group type: Experimental
description: 0.5% ropivacaine 100 mg (20 ml) will be injected
intervention type: Procedure
intervention name: Lumbar plexus block
description: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.
arm group label: Lumbar Plexus block
intervention type: Procedure
intervention name: Quadratus lumborum type 3 block
description: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.
arm group label: Quadratus Lumborum type 3 block
intervention type: Drug
intervention name: Ropivacaine injection
description: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
arm group label: Lumbar Plexus block
arm group label: Quadratus Lumborum type 3 block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sharad Khetarpal, MD
role: Principal Investigator
affiliation: Department of Anesthesiology, University of Pittsburgh Medical Center
facility: 
country: United States
citation: Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3.
PMID: 18719448
citation: Weller RS, Gerancher JC, Crews JC, Wade KL. Extensive retroperitoneal hematoma without neurologic deficit in two patients who underwent lumbar plexus block and were later anticoagulated. Anesthesiology. 2003 Feb;98(2):581-5. doi: 10.1097/00000542-200302000-00044. No abstract available.
PMID: 12552223
citation: Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1.
PMID: 20889937
citation: Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
PMID: 27513972
citation: La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
PMID: 28036319
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: Børglum J, Moriggl B, Jensen K, Lønnqvist P, Christensen AF, Sauter A, Bendtsen TF. Ultrasound-guided transmuscular quadratus lumborum blockade. British Journal of Anaesthesia 111:eLetters Supplement, 2013.
citation: Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Sharad Khetarpal
investigator title: Clinical Assistant Professor
mesh term: Osteoarthritis, Hip
mesh term: Pain, Postoperative
mesh term: Ropivacaine
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was conducted at a single-center, potentially confounding external validity. Though the desired statistical power was achieved, our sample was still small. More non-inferiority studies are needed to confirm our results.
point of contact: 