xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968014</url>
    </required_header>
    <id_info>
      <org_study_id>Chaima Debabi</org_study_id>
      <nct_id>NCT05968014</nct_id>
    </id_info>
    <brief_title>Quality of Recovery After Hip Fracture Surgery: US-guided PENG Block Versus FICB</brief_title>
    <official_title>Quality of Recovery After Hip Fracture Surgery: Ultrasound-guided Pericapsular Nerve Group Block Versus Fascia Iliaca Compartment Block</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Tunis El Manar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Tunis El Manar</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>
        Patients were randomly divided into two groups to receive either ultrasound-guided&#xD;
        pericapsular nerve group block (PENG group) or fascia iliaca compartment block (FICB group),&#xD;
        using 20 ml of 0.2% ropivacaine&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants were randomly divided into two groups : group PENG and group FICB, to receive&#xD;
        either ultrasound-guided pericapsular nerve group block or fascia iliaca compartment block,&#xD;
        using 50 ml of 0.2% ropivacaine.&#xD;
  &#xD;
        For the FICB, a linear ultrasound probe was placed in the transverse plane and start scanning&#xD;
        at the level of the inguinal crease to identify the femoral artery medially and the femoral&#xD;
        nerve lateral to the femoral artery. The iliopsoas muscle should be seen overlying fascia&#xD;
        iliaca. The block should be performed proximal to the arterial bifurcation. A 50 mm needle&#xD;
        was introduced using an in-plane approach to penetrate the fascia iliaca. The hydro&#xD;
        dissection separate the fascia iliaca from the iliac muscle, and a total volume of 20 ml of&#xD;
        0.2% ropivacaine was injected in this created space.&#xD;
  &#xD;
        The PENG bloc is performed with a low frequency curvilinear ultrasound probe, which was&#xD;
        initially placed in a transverse plane over the antero inferior iliac spine and the aligned&#xD;
        with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this&#xD;
        view, it is possible to observe the iliopubic eminence, the iliopsoas muscle tendon, the&#xD;
        femoral artery and the pectineus muscle. A 100 mm needle was inserted from lateral to medial&#xD;
        in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon&#xD;
        anteriorly and the pubic ramus posteriorly. Negative aspiration should be observed before&#xD;
        injection of local anaesthetic and a total volume of 20 ml of 0.2% ropivacaine was injected.&#xD;
  &#xD;
        Spinal anesthesia was performed after 20 minutes.&#xD;
  &#xD;
        QoR-15 score was assessed before the intervention and 24 hours postoperatively.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">July 31, 2022</completion_date>
    <primary_completion_date type="Actual">July 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>
      <intervention_model_description>randomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the PENG group or FICB group. The PENG group was treated with PENG block following randomisation, whereas the FICB group received a fascia iliaca compartment block.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Quality of Recovery-15 scores at 24 hours postoperatively.</measure>
      <time_frame>before and 24 hours after surgery</time_frame>
      <description>Change in Quality of Recovery-15 (QoR-15) scores before and 24 hours after surgery.&#xD;
  The QoR-15 score consists of 15 items, and includes five dimensions: pain (two items), physical confort (five items), physical independance (two items), psychological support (two items) and emotional state (four items). Each item's score ranged from 0 to 10, and the total score ranged from 0 to 150, with a higher QoR-15 score indicating a better quality of recovery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The strength of the quadriceps</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>The strength of the quadriceps muscle was measured 24 hours after surgery. It was determined by testing the movement of the knee and the hip.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual analogue scale</measure>
      <time_frame>24 hours after surgery</time_frame>
      <description>change in visual analogue scale ((VAS) with 0 indicating no pain and 10 indicating the worst imaginable pain) at rest and on movement on postoperative day 1.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Enhanced Recovery After Surgery</condition>
    <arm_group>
      <arm_group_label>PENG block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants enrolled in this group received a pericapsular nerve group block with 20 ml of 0.2% ropivacaine. The block was performed with a 100 mm needle, inserted with an in-plane lateral to medial approach. Operator used a low frequency curvilinear probe.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>FIC block</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients allocated in this group received a fascia iliaca compartment block with 20 mL of 0.2% ropivacaine, using a 50 mm needle inserted with an in-plane approach. Operator used a linear probe.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PENG vs FICB</intervention_name>
      <description>pericapsular nerve group block versus fascia iliaca compartment block</description>
      <arm_group_label>FIC block</arm_group_label>
      <arm_group_label>PENG block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients aged above 65 years&#xD;
  &#xD;
            -  patients with an american society of anesthesiologists physical status I to III&#xD;
  &#xD;
            -  patients undergoing hip fracture surgical repair&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with an american society of anesthesiologists physical status IV or more&#xD;
  &#xD;
            -  inability or refusal to sign informed consent&#xD;
  &#xD;
            -  contraindications for regional nerve block or spinal anesthesia&#xD;
  &#xD;
            -  impaired cognition or dementia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chaima Debabi</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Tunis El Manar</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Nabeul hospital, Mohamed Taher Maamouri</name>
        <address>
          <city>Nabeul</city>
          <state>Mrezga</state>
          <zip>8000</zip>
          <country>Tunisia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Tunisia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Tunis El Manar</investigator_affiliation>
      <investigator_full_name>Chaima Debabi</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>hip fracture surgery</keyword>
    <keyword>PENG block</keyword>
    <keyword>fascia iliaca compartment block</keyword>
    <keyword>quality of recovery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968014
  org study id: Chaima Debabi
  nct id: NCT05968014
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients were randomly divided into two groups to receive either ultrasound-guided
        pericapsular nerve group block (PENG group) or fascia iliaca compartment block (FICB group),
        using 20 ml of 0.2% ropivacaine
  Participants were randomly divided into two groups : group PENG and group FICB, to receive
        either ultrasound-guided pericapsular nerve group block or fascia iliaca compartment block,
        using 50 ml of 0.2% ropivacaine.
  
        For the FICB, a linear ultrasound probe was placed in the transverse plane and start scanning
        at the level of the inguinal crease to identify the femoral artery medially and the femoral
        nerve lateral to the femoral artery. The iliopsoas muscle should be seen overlying fascia
        iliaca. The block should be performed proximal to the arterial bifurcation. A 50 mm needle
        was introduced using an in-plane approach to penetrate the fascia iliaca. The hydro
        dissection separate the fascia iliaca from the iliac muscle, and a total volume of 20 ml of
        0.2% ropivacaine was injected in this created space.
  
        The PENG bloc is performed with a low frequency curvilinear ultrasound probe, which was
        initially placed in a transverse plane over the antero inferior iliac spine and the aligned
        with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this
        view, it is possible to observe the iliopubic eminence, the iliopsoas muscle tendon, the
        femoral artery and the pectineus muscle. A 100 mm needle was inserted from lateral to medial
        in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon
        anteriorly and the pubic ramus posteriorly. Negative aspiration should be observed before
        injection of local anaesthetic and a total volume of 20 ml of 0.2% ropivacaine was injected.
  
        Spinal anesthesia was performed after 20 minutes.
  
        QoR-15 score was assessed before the intervention and 24 hours postoperatively.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomised-controlled trial with two parallel study groups. Participants will be randomised 1:1 to the PENG group or FICB group. The PENG group was treated with PENG block following randomisation, whereas the FICB group received a fascia iliaca compartment block.
  primary purpose: Basic Science
  masking: Single (Outcomes Assessor)
  measure: The Quality of Recovery-15 scores at 24 hours postoperatively.
  time frame: before and 24 hours after surgery
  description: Change in Quality of Recovery-15 (QoR-15) scores before and 24 hours after surgery.
  The QoR-15 score consists of 15 items, and includes five dimensions: pain (two items), physical confort (five items), physical independance (two items), psychological support (two items) and emotional state (four items). Each item's score ranged from 0 to 10, and the total score ranged from 0 to 150, with a higher QoR-15 score indicating a better quality of recovery.
  measure: The strength of the quadriceps
  time frame: 24 hours after surgery
  description: The strength of the quadriceps muscle was measured 24 hours after surgery. It was determined by testing the movement of the knee and the hip.
  measure: Visual analogue scale
  time frame: 24 hours after surgery
  description: change in visual analogue scale ((VAS) with 0 indicating no pain and 10 indicating the worst imaginable pain) at rest and on movement on postoperative day 1.
  arm group label: PENG block
  arm group type: Experimental
  description: Participants enrolled in this group received a pericapsular nerve group block with 20 ml of 0.2% ropivacaine. The block was performed with a 100 mm needle, inserted with an in-plane lateral to medial approach. Operator used a low frequency curvilinear probe.
  arm group label: FIC block
  arm group type: Experimental
  description: Patients allocated in this group received a fascia iliaca compartment block with 20 mL of 0.2% ropivacaine, using a 50 mm needle inserted with an in-plane approach. Operator used a linear probe.
  intervention type: Procedure
  intervention name: PENG vs FICB
  description: pericapsular nerve group block versus fascia iliaca compartment block
  arm group label: FIC block
  arm group label: PENG block
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chaima Debabi
  role: Principal Investigator
  affiliation: University Tunis El Manar
  facility: 
  country: Tunisia
  responsible party type: Principal Investigator
  investigator affiliation: University Tunis El Manar
  investigator full name: Chaima Debabi
  investigator title: Principal Investigator
  mesh term: Hip Fractures
  sharing ipd: No