<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/NCT04426058</url>
  </required_header>
  <id_info>
    <org_study_id>213048</org_study_id>
    <nct_id>NCT04426058</nct_id>
  </id_info>
  <brief_title>CMP vs Fascia Iliaca Block</brief_title>
  <official_title>Complete Motor Sparing Protocol Versus Fascia Iliaca Suprainguinal Technique for Total Hip Arthroplasty, a Prospective Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loyola University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loyola University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Complete motorsparing protocol (CMP) has been developed to try to minimize the motor nerve&#xD;
      block that is created when using Facia iliaca nerve block. The blocks performed in the (CMP)&#xD;
      are the cluneal nerve block, Pericapsular nerve group block and lateral femoral cutaneous&#xD;
      block. On the clinical trial, the investigators will randomize the participants that meet&#xD;
      criteria to CMP or Fascia iliaca Block and compare the amount of opioid needed post op during&#xD;
      24 hours and their pain scores.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 6, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of opioid use</measure>
    <time_frame>24 hours</time_frame>
    <description>Measurement of opioid use (mg) for pain control after surgery once patient in recovery area</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of the pain control</measure>
    <time_frame>24 hours</time_frame>
    <description>Measurement of the pain control via numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>CMP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fascia iliaca</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CMP</intervention_name>
    <description>Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml</description>
    <arm_group_label>CMP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fascia Illica</intervention_name>
    <description>Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml</description>
    <arm_group_label>Fascia iliaca</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years old&#xD;
&#xD;
          -  Patients undergoing total hip arthroplasty posterior approach.&#xD;
&#xD;
          -  Patients willing to participate and sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe COPD/other contraindication to general anesthesia that spinal would be more&#xD;
             suitable.&#xD;
&#xD;
          -  Patient with a weight of less than 41 kg&#xD;
&#xD;
          -  Dementia, not alert or Oriented to person, place, or time&#xD;
&#xD;
          -  Chronic pain patient with daily opioid use at home.&#xD;
&#xD;
          -  Patient with allergy to local anesthetics&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Total hip arthroplasty revision&#xD;
&#xD;
          -  Concomitant pain in different area from operative site.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patient with active infection on the injection sites for the blocks&#xD;
&#xD;
          -  Patients unable or willing to understand or comply with the study protocol&#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_contact>
    <last_name>Carlos Martinez Parra, MD</last_name>
    <phone>(708) 216-6462</phone>
    <email>carlos.martinezparra@lumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Majewski, MD</last_name>
    <phone>(708) 216-6462</phone>
    <email>mimajewski@lumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott Byram, MD</last_name>
      <phone>713-216-5988</phone>
      <email>sbyram@lumc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://rapm.bmj.com/content/early/2019/05/16/rapm-2018-100174?versioned=true</url>
    <description>Randomized trial of ultrasound-guided superior cluneal nerve block</description>
  </link>
  <reference>
    <citation>Tyagi A, Salhotra R. Total hip arthroplasty and peripheral nerve blocks: Limited but salient role? J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):379-380. doi: 10.4103/joacp.JOACP_114_18. No abstract available.</citation>
    <PMID>30386023</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>Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.</citation>
    <PMID>30063657</PMID>
  </reference>
  <reference>
    <citation>Hannon CP, Keating TC, Lange JK, Ricciardi BF, Waddell BS, Della Valle CJ. Anesthesia and Analgesia Practices in Total Joint Arthroplasty: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2019 Dec;34(12):2872-2877.e2. doi: 10.1016/j.arth.2019.06.055. Epub 2019 Jul 8.</citation>
    <PMID>31371038</PMID>
  </reference>
  <reference>
    <citation>Kumar K, Pandey RK, Bhalla AP, Kashyap L, Garg R, Darlong V, Malhotra R, Yadav CS. Comparison of conventional infrainguinal versus modified proximal suprainguinal approach of Fascia Iliaca Compartment Block for postoperative analgesia in Total Hip Arthroplasty. A prospective randomized study. Acta Anaesthesiol Belg. 2015;66(3):95-100.</citation>
    <PMID>26767235</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loyola University</investigator_affiliation>
    <investigator_full_name>Scott Byram MD</investigator_full_name>
    <investigator_title>MD, Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Nerve Block</keyword>
  <keyword>Fascia Iliaca Nerve Block</keyword>
  <keyword>Complete Motor Sparing Protocol</keyword>
  <keyword>Hip Arthroplasty</keyword>
  <keyword>Pain control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>September 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT04426058/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT04426058/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04426058
org study id: 213048
nct id: NCT04426058
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Complete motorsparing protocol (CMP) has been developed to try to minimize the motor nerve
      block that is created when using Facia iliaca nerve block. The blocks performed in the (CMP)
      are the cluneal nerve block, Pericapsular nerve group block and lateral femoral cutaneous
      block. On the clinical trial, the investigators will randomize the participants that meet
      criteria to CMP or Fascia iliaca Block and compare the amount of opioid needed post op during
      24 hours and their pain scores.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Measurement of opioid use
time frame: 24 hours
description: Measurement of opioid use (mg) for pain control after surgery once patient in recovery area
measure: Measurement of the pain control
time frame: 24 hours
description: Measurement of the pain control via numeric rating scale 0-10 where 0 is no pain and 10 is the worst pain.
arm group label: CMP
arm group type: Experimental
description: Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
arm group label: Fascia iliaca
arm group type: Active Comparator
description: Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
intervention type: Drug
intervention name: CMP
description: Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
arm group label: CMP
intervention type: Drug
intervention name: Fascia Illica
description: Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
arm group label: Fascia iliaca
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos Martinez Parra, MD
phone: (708) 216-6462
email: carlos.martinezparra@lumc.edu
last name: Michael Majewski, MD
phone: (708) 216-6462
email: mimajewski@lumc.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://rapm.bmj.com/content/early/2019/05/16/rapm-2018-100174?versioned=true
description: Randomized trial of ultrasound-guided superior cluneal nerve block
citation: Tyagi A, Salhotra R. Total hip arthroplasty and peripheral nerve blocks: Limited but salient role? J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):379-380. doi: 10.4103/joacp.JOACP_114_18. No abstract available.
PMID: 30386023
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: Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847.
PMID: 30063657
citation: Hannon CP, Keating TC, Lange JK, Ricciardi BF, Waddell BS, Della Valle CJ. Anesthesia and Analgesia Practices in Total Joint Arthroplasty: A Survey of the American Association of Hip and Knee Surgeons Membership. J Arthroplasty. 2019 Dec;34(12):2872-2877.e2. doi: 10.1016/j.arth.2019.06.055. Epub 2019 Jul 8.
PMID: 31371038
citation: Kumar K, Pandey RK, Bhalla AP, Kashyap L, Garg R, Darlong V, Malhotra R, Yadav CS. Comparison of conventional infrainguinal versus modified proximal suprainguinal approach of Fascia Iliaca Compartment Block for postoperative analgesia in Total Hip Arthroplasty. A prospective randomized study. Acta Anaesthesiol Belg. 2015;66(3):95-100.
PMID: 26767235
responsible party type: Principal Investigator
investigator affiliation: Loyola University
investigator full name: Scott Byram MD
investigator title: MD, Associate Professor
mesh term: Pain, Postoperative
sharing ipd: No
provided document: 
provided document: 