<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/NCT04402437</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00098482</org_study_id>
    <nct_id>NCT04402437</nct_id>
  </id_info>
  <brief_title>QL vs LP Blocks for Analgesia Following THA</brief_title>
  <official_title>Utilization of Quadratus Lumborum Versus Lumbar Plexus Blocks for Postoperative Analgesia Following Hip Arthroplasty: A Prospective, Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose: Evaluate difference in postoperative opioid consumption when subjects receive a&#xD;
      quadratus lumborum (QL) or lumbar plexus (LP) block preoperatively for total hip arthroplasty&#xD;
      (THA).&#xD;
&#xD;
      Hypothesis: Preoperative QL and LP blocks will result in similar postoperative opioid&#xD;
      consumption following hip arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the goal of improving physical function and quality of life, the demand for total hip&#xD;
      arthroplasty (THA) continues to grow. However, postoperative pain associated with THA remains&#xD;
      a serious concern for patients. In the middle of a growing opioid epidemic, multimodal&#xD;
      approaches utilizing both non-opioid analgesics and regional anesthetic techniques are being&#xD;
      increasingly sought.&#xD;
&#xD;
      Regional anesthetic techniques are associated with both decreased opioid consumption and pain&#xD;
      scores compared with systemic analgesia alone. However, regional techniques for THA are&#xD;
      seldom compared. Lumbar plexus blocks are commonly performed for postoperative analgesia for&#xD;
      THA. However, more recent case reports have described utilizing quadratus lumborum blocks for&#xD;
      analgesia following hip fracture and THA.&#xD;
&#xD;
      This prospective study would randomize subjects to receive a lumbar plexus block or quadratus&#xD;
      lumborum block prior to THA. The primary end point would be opioid consumption at 12 hours&#xD;
      postoperative. Our hypothesis is that opioid consumption will not differ between groups.&#xD;
&#xD;
      The quadratus lumborum block is a fascial plane block. Originally described for abdominal&#xD;
      surgery, numerous case reports and editorial publications have highlighted the effectiveness&#xD;
      of quadratus lumborum (QL) blocks as an analgesic technique for hip fracture and hip&#xD;
      arthroplasty. However, prospective randomized studies comparing QL blocks to other regional&#xD;
      techniques for THA analgesia are lacking.&#xD;
&#xD;
      The lateral approach to the QL block is performed by injecting local anesthetic deep to the&#xD;
      transversus abdominus abdominus apnoneurosis and superficial to the fascia transversalis with&#xD;
      direct ultrasound guidance. After completing consent, placing monitors and providing mild&#xD;
      sedation, the subject is positioned laterally and the muscular anatomy (external oblique,&#xD;
      internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles)&#xD;
      identified. After placing a subcutaneous skin wheal with lidiocaine, a blunt regional&#xD;
      anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is&#xD;
      deposited incrementally with frequent aspiration in the anterolateral border of the quadratus&#xD;
      lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of&#xD;
      the thoracolumbar fascia and superficial to the fascia transversalis.&#xD;
&#xD;
      Risks of anterior approach to the quadratus lumborum block are similar to most truncal blocks&#xD;
      and include infection, bleeding, bowel perforation or local anesthetic toxicity (LAST).&#xD;
      Infection risk is minimized by utilizing appropriate antiseptic and sterile technique as is&#xD;
      standard for any regional procedure. Risk of a retroperitoneal hematoma is increased with the&#xD;
      posterior approach to the quadratus lumborum block because of its transmuscular approach and&#xD;
      likelihood of abdominal branches of lumbar arteries in the path of the needle. For this&#xD;
      reason, the posterior approach to the quadratus lumborum block will not be used for this&#xD;
      study. The risk of LAST is a risk with any regional procedure and is minimized by frequent&#xD;
      aspiration, incremental local anesthetic injection and vital signs monitoring throughout.&#xD;
&#xD;
      The quadratus lumborum block is already a block utilized for a variety of surgical procedures&#xD;
      to decrease postoperative pain. Potential benefits to the QL block over the common lumbar&#xD;
      plexus block include more superficial block placement and ultrasound visualization. The&#xD;
      investigator hypothesize that preoperative QL blocks will reduce opioid consumption similar&#xD;
      to lumbar plexus blocks following elective hip arthroplasty.&#xD;
&#xD;
      Information regarding the study will be presented to subjects in the surgical clinic or&#xD;
      preoperative anesthesia clinic in the preoperative period. Subjects will be educated on the&#xD;
      role of regional anesthesia in postoperative analgesia. Subjects will be able to consider the&#xD;
      study until the day of surgery. On the day of surgery, subjects may then choose to provide&#xD;
      written consent or decline to participate.&#xD;
&#xD;
      Subjects will be enrolled on the day of surgery in the preoperative holding area.&#xD;
&#xD;
      After discussion in the preoperative holding area regarding risks and benefits of both the&#xD;
      lumbar plexus and QL block, subjects will be consented if they choose to participate. Consent&#xD;
      will be obtained from subject by an IRB approved CITI certified study team member that has&#xD;
      been trained on the protocol. Written consent with a witness will be completed once all&#xD;
      questions are answered and exclusion and inclusion verified. Copies of all documents will be&#xD;
      provided to the subjects. Once subjects are consented, they will be assigned an enrollment&#xD;
      number. Prior to subject enrollment, randomization will done by a statistician and randomized&#xD;
      group (lumbar plexus block (current practice) or QL block) assigned based on the subject&#xD;
      enrollment number.&#xD;
&#xD;
      Design: This prospective, single blinded clinical trial will randomize subject to receive a&#xD;
      lumbar plexus or QL block prior to THA. The randomization will be created by a statistician&#xD;
      prior to subject enrollment.&#xD;
&#xD;
      Groups: Subjects will be randomized to receive a preoperative lumbar plexus (n = 100) or QL&#xD;
      (n = 100 ) block prior to THA.&#xD;
&#xD;
      Potential participants that are on the operating room schedule for THA will be screened for&#xD;
      eligibility via chart review.&#xD;
&#xD;
      Once subjects have signed an informed consent, they will be assigned an enrollment number.&#xD;
      Numbers would be assigned sequentially with the first enrolled subject receiving &quot;001,&quot; the&#xD;
      second subject receiving &quot;002,&quot; and the last subject receiving number &quot;184.&quot; Randomization&#xD;
      will be created prior to the study starting by a statistician with half of the research&#xD;
      subject number being assigned to receive a QL block and the other half assigned to receive a&#xD;
      lumbar plexus block, which is our current standard of care. The regional anesthesia team will&#xD;
      open the envelope labeled with the subject's assigned number to reveal the randomization.&#xD;
&#xD;
      Following informed consent, all subjects will be positioned, prepped and sedated for the&#xD;
      randomized regional anesthesia procedure in the preoperative holding area. The subject will&#xD;
      be positioned in the lateral decubitus position with the operative side up and pulse oximetry&#xD;
      and blood pressure cuff placed for monitoring. As part of routine care, the subject will&#xD;
      receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in&#xD;
      their nerve block regardless of randomization. The relevant anatomy will then be identified&#xD;
      using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum&#xD;
      block). All participants, regardless of group assignment, will be positioned, have an area on&#xD;
      their back and side cleaned, have an ultrasound placed, and numbing medication placed just&#xD;
      below the skin at both block sites (skin wheal). This will be done so that participant and&#xD;
      the team collecting result will be blinded. Subject, surgeon, intraoperative anesthesia team&#xD;
      and data collectors would all be blinded to the allocated group.&#xD;
&#xD;
      Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine&#xD;
      skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A&#xD;
      nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to&#xD;
      the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and&#xD;
      maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with&#xD;
      frequent aspiration to rule out inadvertent intravascular needle placement.&#xD;
&#xD;
      Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine&#xD;
      skin wheal that will be placed after ultrasound identification of external oblique, internal&#xD;
      oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced&#xD;
      under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus&#xD;
      lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to&#xD;
      rule out inadvertent intravascular needle placement. Local anesthetic injection will also be&#xD;
      observed with real time ultrasound guidance.&#xD;
&#xD;
      The participant's chart will be reviewed for data collection.&#xD;
&#xD;
      Participants will also be asked to perform a Visual Analog Scale pain score preoperatively&#xD;
      (baseline), postoperatively (once awake) and approximately 24 hours post operatively.&#xD;
&#xD;
      Care in the perioperative period will otherwise be standardized. In the post-anesthesia care&#xD;
      unit (PACU), hydromorphone or morphine will be titrated by the PACU nurse for the subject's&#xD;
      comfort.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">June 4, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>All subjects will be positioned, prepped and sedated for the randomized regional anesthesia procedure in the preoperative holding area. The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine. Subject, surgeon, intraoperative anesthesia team and data collectors would all be blinded to the allocated group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid consumption</measure>
    <time_frame>12 hours</time_frame>
    <description>Opioid consumption including intraoperative consumption</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid consumption 8 hours postoperative</measure>
    <time_frame>8 hours</time_frame>
    <description>Opioid consumption including intraoperative consumption</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Receives LP Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Receives QL Block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LP Block</intervention_name>
    <description>Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.</description>
    <arm_group_label>Receives LP Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>QL Block</intervention_name>
    <description>Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.</description>
    <arm_group_label>Receives QL Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years-old&#xD;
&#xD;
          -  Undergoing elective hip arthroplasty.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Local anesthetic allergy&#xD;
&#xD;
          -  Chlorhexidine allergy&#xD;
&#xD;
          -  Subjects with a weight less than 40kg&#xD;
&#xD;
          -  Subjects that are unable or choose not to give informed consent&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Known preoperative substance abuse&#xD;
&#xD;
          -  Allergy to all opioids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvia H Wilson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Learmonth ID, Young C, Rorabeck C. The operation of the century: total hip replacement. Lancet. 2007 Oct 27;370(9597):1508-19. doi: 10.1016/S0140-6736(07)60457-7.</citation>
    <PMID>17964352</PMID>
  </reference>
  <reference>
    <citation>Bruyere O, Ethgen O, Neuprez A, Zegels B, Gillet P, Huskin JP, Reginster JY. Health-related quality of life after total knee or hip replacement for osteoarthritis: a 7-year prospective study. Arch Orthop Trauma Surg. 2012 Nov;132(11):1583-7. doi: 10.1007/s00402-012-1583-7. Epub 2012 Jul 28.</citation>
    <PMID>22842917</PMID>
  </reference>
  <reference>
    <citation>Ethgen O, Bruyere O, Richy F, Dardennes C, Reginster JY. Health-related quality of life in total hip and total knee arthroplasty. A qualitative and systematic review of the literature. J Bone Joint Surg Am. 2004 May;86(5):963-74. doi: 10.2106/00004623-200405000-00012.</citation>
    <PMID>15118039</PMID>
  </reference>
  <reference>
    <citation>Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.</citation>
    <PMID>20462458</PMID>
  </reference>
  <reference>
    <citation>Becchi C, Al Malyan M, Coppini R, Campolo M, Magherini M, Boncinelli S. Opioid-free analgesia by continuous psoas compartment block after total hip arthroplasty. A randomized study. Eur J Anaesthesiol. 2008 May;25(5):418-23. doi: 10.1017/S026502150700302X. Epub 2007 Nov 21.</citation>
    <PMID>18028577</PMID>
  </reference>
  <reference>
    <citation>Biboulet P, Morau D, Aubas P, Bringuier-Branchereau S, Capdevila X. Postoperative analgesia after total-hip arthroplasty: Comparison of intravenous patient-controlled analgesia with morphine and single injection of femoral nerve or psoas compartment block. a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2004 Mar-Apr;29(2):102-9. doi: 10.1016/j.rapm.2003.11.006.</citation>
    <PMID>15029544</PMID>
  </reference>
  <reference>
    <citation>Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anaesthesia improve outcome after total hip arthroplasty? A systematic review. Br J Anaesth. 2009 Sep;103(3):335-45. doi: 10.1093/bja/aep208. Epub 2009 Jul 23.</citation>
    <PMID>19628483</PMID>
  </reference>
  <reference>
    <citation>Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.</citation>
    <PMID>10861154</PMID>
  </reference>
  <reference>
    <citation>Harvey NR, Wolf BJ, Bolin ED, Wilson SH. Comparison of analgaesia with lumbar epidurals and lumbar plexus nerve blocks in patients receiving multimodal analgaesics following primary total hip arthroplasty: a retrospective analysis. Int Orthop. 2017 Nov;41(11):2229-2235. doi: 10.1007/s00264-017-3465-7. Epub 2017 Apr 11.</citation>
    <PMID>28396932</PMID>
  </reference>
  <reference>
    <citation>Wilson SH, Wolf BJ, Algendy AA, Sealy C, Demos HA, McSwain JR. Comparison of Lumbar Epidurals and Lumbar Plexus Nerve Blocks for Analgesia Following Primary Total Hip Arthroplasty: A Retrospective Analysis. J Arthroplasty. 2017 Feb;32(2):635-640. doi: 10.1016/j.arth.2016.07.042. Epub 2016 Aug 10.</citation>
    <PMID>27597428</PMID>
  </reference>
  <reference>
    <citation>Wilson SH, Auroux AS, Eloy JD, Merman RB, Chelly JE. Ropivacaine 0.1% versus 0.2% for continuous lumbar plexus nerve block infusions following total hip arthroplasty: a randomized, double blinded study. Pain Med. 2014 Mar;15(3):465-72. doi: 10.1111/pme.12309. Epub 2013 Dec 11.</citation>
    <PMID>24330381</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>Johnston DF, Sondekoppam RV. Continuous quadratus lumborum block analgesia for total hip arthroplasty revision. J Clin Anesth. 2016 Dec;35:235-237. doi: 10.1016/j.jclinane.2016.08.002. Epub 2016 Sep 26. No abstract available.</citation>
    <PMID>27871532</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>La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.</citation>
    <PMID>27997495</PMID>
  </reference>
  <reference>
    <citation>Ueshima H, Yoshiyama S, Otake H. RETRACTED: The ultrasound-guided continuous transmuscular quadratus lumborum block is an effective analgesia for total hip arthroplasty. J Clin Anesth. 2016 Jun;31:35. doi: 10.1016/j.jclinane.2015.12.033. Epub 2016 Mar 22. No abstract available.</citation>
    <PMID>27185672</PMID>
  </reference>
  <reference>
    <citation>Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.</citation>
    <PMID>26771297</PMID>
  </reference>
  <reference>
    <citation>Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13, table of contents. doi: 10.1097/00000539-200206000-00045.</citation>
    <PMID>12032037</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Sylvia Wilson</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04402437
org study id: Pro00098482
nct id: NCT04402437
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Purpose: Evaluate difference in postoperative opioid consumption when subjects receive a
      quadratus lumborum (QL) or lumbar plexus (LP) block preoperatively for total hip arthroplasty
      (THA).

      Hypothesis: Preoperative QL and LP blocks will result in similar postoperative opioid
      consumption following hip arthroplasty.
With the goal of improving physical function and quality of life, the demand for total hip
      arthroplasty (THA) continues to grow. However, postoperative pain associated with THA remains
      a serious concern for patients. In the middle of a growing opioid epidemic, multimodal
      approaches utilizing both non-opioid analgesics and regional anesthetic techniques are being
      increasingly sought.

      Regional anesthetic techniques are associated with both decreased opioid consumption and pain
      scores compared with systemic analgesia alone. However, regional techniques for THA are
      seldom compared. Lumbar plexus blocks are commonly performed for postoperative analgesia for
      THA. However, more recent case reports have described utilizing quadratus lumborum blocks for
      analgesia following hip fracture and THA.

      This prospective study would randomize subjects to receive a lumbar plexus block or quadratus
      lumborum block prior to THA. The primary end point would be opioid consumption at 12 hours
      postoperative. Our hypothesis is that opioid consumption will not differ between groups.

      The quadratus lumborum block is a fascial plane block. Originally described for abdominal
      surgery, numerous case reports and editorial publications have highlighted the effectiveness
      of quadratus lumborum (QL) blocks as an analgesic technique for hip fracture and hip
      arthroplasty. However, prospective randomized studies comparing QL blocks to other regional
      techniques for THA analgesia are lacking.

      The lateral approach to the QL block is performed by injecting local anesthetic deep to the
      transversus abdominus abdominus apnoneurosis and superficial to the fascia transversalis with
      direct ultrasound guidance. After completing consent, placing monitors and providing mild
      sedation, the subject is positioned laterally and the muscular anatomy (external oblique,
      internal oblique, transverse abdominis, quadratus lumborum and latissimus dorsi muscles)
      identified. After placing a subcutaneous skin wheal with lidiocaine, a blunt regional
      anesthesia needle is inserted using in-plane ultrasound guidance. Local anesthetic is
      deposited incrementally with frequent aspiration in the anterolateral border of the quadratus
      lumborum muscle at the junction of the transversalis fascia, outside the anterior layer of
      the thoracolumbar fascia and superficial to the fascia transversalis.

      Risks of anterior approach to the quadratus lumborum block are similar to most truncal blocks
      and include infection, bleeding, bowel perforation or local anesthetic toxicity (LAST).
      Infection risk is minimized by utilizing appropriate antiseptic and sterile technique as is
      standard for any regional procedure. Risk of a retroperitoneal hematoma is increased with the
      posterior approach to the quadratus lumborum block because of its transmuscular approach and
      likelihood of abdominal branches of lumbar arteries in the path of the needle. For this
      reason, the posterior approach to the quadratus lumborum block will not be used for this
      study. The risk of LAST is a risk with any regional procedure and is minimized by frequent
      aspiration, incremental local anesthetic injection and vital signs monitoring throughout.

      The quadratus lumborum block is already a block utilized for a variety of surgical procedures
      to decrease postoperative pain. Potential benefits to the QL block over the common lumbar
      plexus block include more superficial block placement and ultrasound visualization. The
      investigator hypothesize that preoperative QL blocks will reduce opioid consumption similar
      to lumbar plexus blocks following elective hip arthroplasty.

      Information regarding the study will be presented to subjects in the surgical clinic or
      preoperative anesthesia clinic in the preoperative period. Subjects will be educated on the
      role of regional anesthesia in postoperative analgesia. Subjects will be able to consider the
      study until the day of surgery. On the day of surgery, subjects may then choose to provide
      written consent or decline to participate.

      Subjects will be enrolled on the day of surgery in the preoperative holding area.

      After discussion in the preoperative holding area regarding risks and benefits of both the
      lumbar plexus and QL block, subjects will be consented if they choose to participate. Consent
      will be obtained from subject by an IRB approved CITI certified study team member that has
      been trained on the protocol. Written consent with a witness will be completed once all
      questions are answered and exclusion and inclusion verified. Copies of all documents will be
      provided to the subjects. Once subjects are consented, they will be assigned an enrollment
      number. Prior to subject enrollment, randomization will done by a statistician and randomized
      group (lumbar plexus block (current practice) or QL block) assigned based on the subject
      enrollment number.

      Design: This prospective, single blinded clinical trial will randomize subject to receive a
      lumbar plexus or QL block prior to THA. The randomization will be created by a statistician
      prior to subject enrollment.

      Groups: Subjects will be randomized to receive a preoperative lumbar plexus (n = 100) or QL
      (n = 100 ) block prior to THA.

      Potential participants that are on the operating room schedule for THA will be screened for
      eligibility via chart review.

      Once subjects have signed an informed consent, they will be assigned an enrollment number.
      Numbers would be assigned sequentially with the first enrolled subject receiving "001," the
      second subject receiving "002," and the last subject receiving number "184." Randomization
      will be created prior to the study starting by a statistician with half of the research
      subject number being assigned to receive a QL block and the other half assigned to receive a
      lumbar plexus block, which is our current standard of care. The regional anesthesia team will
      open the envelope labeled with the subject's assigned number to reveal the randomization.

      Following informed consent, all subjects will be positioned, prepped and sedated for the
      randomized regional anesthesia procedure in the preoperative holding area. The subject will
      be positioned in the lateral decubitus position with the operative side up and pulse oximetry
      and blood pressure cuff placed for monitoring. As part of routine care, the subject will
      receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in
      their nerve block regardless of randomization. The relevant anatomy will then be identified
      using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum
      block). All participants, regardless of group assignment, will be positioned, have an area on
      their back and side cleaned, have an ultrasound placed, and numbing medication placed just
      below the skin at both block sites (skin wheal). This will be done so that participant and
      the team collecting result will be blinded. Subject, surgeon, intraoperative anesthesia team
      and data collectors would all be blinded to the allocated group.

      Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine
      skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A
      nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to
      the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and
      maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with
      frequent aspiration to rule out inadvertent intravascular needle placement.

      Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine
      skin wheal that will be placed after ultrasound identification of external oblique, internal
      oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced
      under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus
      lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to
      rule out inadvertent intravascular needle placement. Local anesthetic injection will also be
      observed with real time ultrasound guidance.

      The participant's chart will be reviewed for data collection.

      Participants will also be asked to perform a Visual Analog Scale pain score preoperatively
      (baseline), postoperatively (once awake) and approximately 24 hours post operatively.

      Care in the perioperative period will otherwise be standardized. In the post-anesthesia care
      unit (PACU), hydromorphone or morphine will be titrated by the PACU nurse for the subject's
      comfort.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine.
primary purpose: Treatment
masking: Single (Participant)
masking description: All subjects will be positioned, prepped and sedated for the randomized regional anesthesia procedure in the preoperative holding area. The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine. Subject, surgeon, intraoperative anesthesia team and data collectors would all be blinded to the allocated group.
measure: Opioid consumption
time frame: 12 hours
description: Opioid consumption including intraoperative consumption
measure: Opioid consumption 8 hours postoperative
time frame: 8 hours
description: Opioid consumption including intraoperative consumption
arm group label: Receives LP Block
arm group type: Active Comparator
description: Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.
arm group label: Receives QL Block
arm group type: Active Comparator
description: Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.
intervention type: Procedure
intervention name: LP Block
description: Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.
arm group label: Receives LP Block
intervention type: Procedure
intervention name: QL Block
description: Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.
arm group label: Receives QL Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sylvia H Wilson, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
facility: 
country: United States
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citation: Biboulet P, Morau D, Aubas P, Bringuier-Branchereau S, Capdevila X. Postoperative analgesia after total-hip arthroplasty: Comparison of intravenous patient-controlled analgesia with morphine and single injection of femoral nerve or psoas compartment block. a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2004 Mar-Apr;29(2):102-9. doi: 10.1016/j.rapm.2003.11.006.
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citation: Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anaesthesia improve outcome after total hip arthroplasty? A systematic review. Br J Anaesth. 2009 Sep;103(3):335-45. doi: 10.1093/bja/aep208. Epub 2009 Jul 23.
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citation: Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.
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citation: Harvey NR, Wolf BJ, Bolin ED, Wilson SH. Comparison of analgaesia with lumbar epidurals and lumbar plexus nerve blocks in patients receiving multimodal analgaesics following primary total hip arthroplasty: a retrospective analysis. Int Orthop. 2017 Nov;41(11):2229-2235. doi: 10.1007/s00264-017-3465-7. Epub 2017 Apr 11.
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citation: Wilson SH, Wolf BJ, Algendy AA, Sealy C, Demos HA, McSwain JR. Comparison of Lumbar Epidurals and Lumbar Plexus Nerve Blocks for Analgesia Following Primary Total Hip Arthroplasty: A Retrospective Analysis. J Arthroplasty. 2017 Feb;32(2):635-640. doi: 10.1016/j.arth.2016.07.042. Epub 2016 Aug 10.
PMID: 27597428
citation: Wilson SH, Auroux AS, Eloy JD, Merman RB, Chelly JE. Ropivacaine 0.1% versus 0.2% for continuous lumbar plexus nerve block infusions following total hip arthroplasty: a randomized, double blinded study. Pain Med. 2014 Mar;15(3):465-72. doi: 10.1111/pme.12309. Epub 2013 Dec 11.
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citation: Johnston DF, Sondekoppam RV. Continuous quadratus lumborum block analgesia for total hip arthroplasty revision. J Clin Anesth. 2016 Dec;35:235-237. doi: 10.1016/j.jclinane.2016.08.002. Epub 2016 Sep 26. No abstract available.
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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.
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citation: La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.
PMID: 27997495
citation: Ueshima H, Yoshiyama S, Otake H. RETRACTED: The ultrasound-guided continuous transmuscular quadratus lumborum block is an effective analgesia for total hip arthroplasty. J Clin Anesth. 2016 Jun;31:35. doi: 10.1016/j.jclinane.2015.12.033. Epub 2016 Mar 22. No abstract available.
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PMID: 26771297
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PMID: 12032037
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Sylvia Wilson
investigator title: Associate Professor
sharing ipd: No