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/NCT05965544</url>
    </required_header>
    <id_info>
      <org_study_id>e.mendes - 2</org_study_id>
      <secondary_id>KAEK/2023.06.259</secondary_id>
      <nct_id>NCT05965544</nct_id>
    </id_info>
    <brief_title>The Effect of Fascia Iliaca Compartment Block (FICB) on QoR-15 Score in Partial Hip Arthroplasty Surgery</brief_title>
    <acronym>QoR-15</acronym>
    <official_title>The Effect of Application of Fascia Iliaca Compartment Block (FICB) Before or After Spinal Anesthesia on QoR-15 Score in Partial Hip Arthroplasty Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Basaksehir Cam &amp; Sakura Şehir Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Basaksehir Cam &amp; Sakura Şehir Hospital</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>
        It reduces pain scores in patients with block and improves the quality of recovery in the&#xD;
        postoperative period. In patients who will undergo spinal anesthesia, it will be questioned&#xD;
        whether the application of the block before or after surgery makes a difference in the&#xD;
        quality of recovery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        American Society of Anesthesiologists (ASA) physical status I-III patients who are planned&#xD;
        for partial hip arthroplasty will be studied in patients over 65 years of age. The patients&#xD;
        will be equally randomized into two groups using a computer-generated random number table. In&#xD;
        the preoperative period, according to whether FIBP was before or after spinal anesthesia, it&#xD;
        will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).&#xD;
        The patient will be placed in the lateral decubitus position with the fractured side up.&#xD;
        After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% isobaric&#xD;
        bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle&#xD;
        through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine&#xD;
        position and aseptic conditions are provided, the fascia on the Iliacus muscle will be&#xD;
        determined with the help of an 8-12 MHz linear probe, and the block will be applied with the&#xD;
        in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine&#xD;
        concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and&#xD;
        sedation need, postoperative pain scores, additional analgesic need, hospitalization and&#xD;
        24th-hour recovery scores will be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 2, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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 patients were equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it was named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Care Provider, Outcomes Assessor)</masking>
      <masking_description>After each patient's eligibility has been assessed, numbered and sealed envelopes will be used to conceal assignment status. The same clinician (E.M.) will perform the patient's pre- and post-operative procedures. A researcher who does not know which method was applied to the patient in the perioperative and postoperative follow-ups will be included as double-blind.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline QoR-15 at 24 hours postoperatively</measure>
      <time_frame>Postoperative 24th-hours</time_frame>
      <description>The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively</measure>
      <time_frame>Postoperative 24th-hours</time_frame>
      <description>Postoperative delirium will be determined with the Nursing Delirium Screening Scale (N-DSS), an easily applicable five-item screening tool that evaluates disorientation, inappropriate behavior, inappropriate communication, hallucination, and psychomotor retardation. Each item scores between 0 and 2 and the total score varies between 0 and 10.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative nausea and vomiting</measure>
      <time_frame>Postoperative 24th hour</time_frame>
      <description>The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Analgesic consumption</measure>
      <time_frame>Postoperative 24th hour</time_frame>
      <description>The value in mg of the amount of analgesic consumed in the postoperative period</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Post Operative Pain</condition>
    <condition>Anesthesia, Local</condition>
    <condition>Fracture of Hip</condition>
    <condition>QoR-15</condition>
    <arm_group>
      <arm_group_label>Group PreS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The block will be applied in the preoperative period</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group PostS</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The block will be applied in the postoperative period</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacain (preoperative)</intervention_name>
      <description>After the patients are in the supine position and aseptic conditions are provided in the preoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.</description>
      <arm_group_label>Group PreS</arm_group_label>
      <other_name>Preoperative Fascia Iliaca Compartment Block</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacaine-fentanyl</intervention_name>
      <description>The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space</description>
      <arm_group_label>Group PostS</arm_group_label>
      <arm_group_label>Group PreS</arm_group_label>
      <other_name>Spinal Anesthesia</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bupivacain (Postoperative)</intervention_name>
      <description>After the patients are in the supine position and aseptic conditions are provided in the postoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.</description>
      <arm_group_label>Group PostS</arm_group_label>
      <other_name>Postoperative Fascia Iliaca Compartment Block</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Partial Hip Arthroplasty&#xD;
  &#xD;
            -  American Society of Anesthesiologists (ASA) physical status I-III,&#xD;
  &#xD;
            -  Patients aged ≥ 65 years&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Contraindication for central or peripheral blocks,&#xD;
  &#xD;
            -  Cognitive Dysfunction,&#xD;
  &#xD;
            -  History of chronic opioid use,&#xD;
  &#xD;
            -  Previous hip surgery,&#xD;
  &#xD;
            -  Serious organ dysfunction,&#xD;
  &#xD;
            -  Allergy to any drug used in the study,&#xD;
  &#xD;
            -  Body mass index (BMI) ≥30,&#xD;
  &#xD;
            -  Infection in the area to be treated,&#xD;
  &#xD;
            -  Refusal to participate in the study&#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>Ergun Mendes</last_name>
      <role>Principal Investigator</role>
      <affiliation>Basaksehir Cam &amp; Sakura Şehir Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ergun Mendes</last_name>
      <phone>+905514265012</phone>
      <email>erg.mendes@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ergun Mendes</name>
        <address>
          <city>Küçükçekmece</city>
          <state>İ̇stanbul</state>
          <zip>34000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ergun Mendes</last_name>
        <phone>+905514265012</phone>
        <email>erg.mendes@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.</citation>
      <PMID>36511494</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Basaksehir Cam &amp; Sakura Şehir Hospital</investigator_affiliation>
      <investigator_full_name>Ergün Mendeş</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Fascia Iliaca Compartment Block</keyword>
    <keyword>FICB</keyword>
    <keyword>Partial Hip Arthroplasty Surgery</keyword>
    <keyword>Quality of Recovery-15</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Hip Fractures</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fentanyl</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Individual participant data (IPD) will not be shared</ipd_description>
    </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/NCT05965544
  org study id: e.mendes - 2
  secondary id: KAEK/2023.06.259
  nct id: NCT05965544
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  It reduces pain scores in patients with block and improves the quality of recovery in the
        postoperative period. In patients who will undergo spinal anesthesia, it will be questioned
        whether the application of the block before or after surgery makes a difference in the
        quality of recovery.
  American Society of Anesthesiologists (ASA) physical status I-III patients who are planned
        for partial hip arthroplasty will be studied in patients over 65 years of age. The patients
        will be equally randomized into two groups using a computer-generated random number table. In
        the preoperative period, according to whether FIBP was before or after spinal anesthesia, it
        will be named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).
        The patient will be placed in the lateral decubitus position with the fractured side up.
        After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% isobaric
        bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle
        through the L3-L4 or L4-L5 intervertebral space. After the patients are in the supine
        position and aseptic conditions are provided, the fascia on the Iliacus muscle will be
        determined with the help of an 8-12 MHz linear probe, and the block will be applied with the
        in-plane technique. During the block, patients will routinely administer 0.2% bupivacaine
        concentration of 0.5 mL/kg. Demographic data, operation time, perioperative analgesic and
        sedation need, postoperative pain scores, additional analgesic need, hospitalization and
        24th-hour recovery scores will be evaluated.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The patients were equally randomized into two groups using a computer-generated random number table. In the preoperative period, according to whether FIBP was before or after spinal anesthesia, it was named as a separate group as Group PreS (Pre-Spinal) and Group PostS (Post-Spinal).
  primary purpose: Supportive Care
  masking: Double (Care Provider, Outcomes Assessor)
  masking description: After each patient's eligibility has been assessed, numbered and sealed envelopes will be used to conceal assignment status. The same clinician (E.M.) will perform the patient's pre- and post-operative procedures. A researcher who does not know which method was applied to the patient in the perioperative and postoperative follow-ups will be included as double-blind.
  measure: Change from baseline QoR-15 at 24 hours postoperatively
  time frame: Postoperative 24th-hours
  description: The patient-reported Turkish QoR-15 score includes 15 questions that evaluate the patient's postoperative recovery. The QoR-15 score is grouped under two groups, A and B. A high QoR-15 score, a score between 0 (poor) and 10 (excellent) for each item, and a total score of 150 indicate better quality of recovery.
  measure: Change from baseline Nursing Delirium Screening Scale (N-DSS) at 24 hours postoperatively
  time frame: Postoperative 24th-hours
  description: Postoperative delirium will be determined with the Nursing Delirium Screening Scale (N-DSS), an easily applicable five-item screening tool that evaluates disorientation, inappropriate behavior, inappropriate communication, hallucination, and psychomotor retardation. Each item scores between 0 and 2 and the total score varies between 0 and 10.
  measure: Postoperative nausea and vomiting
  time frame: Postoperative 24th hour
  description: The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
  measure: Analgesic consumption
  time frame: Postoperative 24th hour
  description: The value in mg of the amount of analgesic consumed in the postoperative period
  arm group label: Group PreS
  arm group type: Active Comparator
  description: The block will be applied in the preoperative period
  arm group label: Group PostS
  arm group type: Active Comparator
  description: The block will be applied in the postoperative period
  intervention type: Drug
  intervention name: Bupivacain (preoperative)
  description: After the patients are in the supine position and aseptic conditions are provided in the preoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.
  arm group label: Group PreS
  other name: Preoperative Fascia Iliaca Compartment Block
  intervention type: Drug
  intervention name: Bupivacaine-fentanyl
  description: The patient will be placed in the lateral decubitus position with the fractured side up. After the spinal anesthesia method was provided with aseptic conditions, 10 mg 0.5% bupivacaine + 20 mcg Fentanyl injection will be applied using a 26 Gauge pencil point needle through the L3-L4 or L4-L5 intervertebral space
  arm group label: Group PostS
  arm group label: Group PreS
  other name: Spinal Anesthesia
  intervention type: Drug
  intervention name: Bupivacain (Postoperative)
  description: After the patients are in the supine position and aseptic conditions are provided in the postoperative period, the fascia on the iliacus muscle will be determined with the help of an 8-12 MHz linear probe and a block will be applied with the in-plane technique. During the block, 0.2% bupivacaine concentration 0.5 mL/kg is routinely used in patients.
  arm group label: Group PostS
  other name: Postoperative Fascia Iliaca Compartment Block
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ergun Mendes
  role: Principal Investigator
  affiliation: Basaksehir Cam & Sakura Şehir Hospital
  last name: Ergun Mendes
  phone: +905514265012
  email: erg.mendes@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Selvi O, Azizoglu M, Temel G, Tulgar S, Chitneni A, Cinar EN, Ozer Z, Gurkan Y. Translation and Validation of the Turkish Version of the Quality of Postoperative Recovery Score QoR-15: A Multi-Centred Cohort Study. Turk J Anaesthesiol Reanim. 2022 Dec;50(6):443-448. doi: 10.5152/TJAR.2022.21417.
  PMID: 36511494
  responsible party type: Principal Investigator
  investigator affiliation: Basaksehir Cam & Sakura Şehir Hospital
  investigator full name: Ergün Mendeş
  investigator title: Principal Investigator
  mesh term: Pain, Postoperative
  mesh term: Hip Fractures
  mesh term: Fentanyl
  mesh term: Bupivacaine
  sharing ipd: No
  ipd description: Individual participant data (IPD) will not be shared