<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/NCT04404959</url>
  </required_header>
  <id_info>
    <org_study_id>Delirium-Pain-Hip Fracture</org_study_id>
    <nct_id>NCT04404959</nct_id>
  </id_info>
  <brief_title>Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture</brief_title>
  <acronym>Delirium-Hip</acronym>
  <official_title>Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aretaieion University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>KAT General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aretaieion University 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>
      The objective of this trial will be to establish whether the ultrasound-guided suprainguinal&#xD;
      fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture&#xD;
      from delirium as compared to placebo&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Geriatric patients suffer from hip fractures very often. Delirium is a perioperative&#xD;
      neuropsychiatric complication that is characterized by sudden change of mental status,&#xD;
      inattention, disorientation and memory impairment with fluctuations of symptoms during the&#xD;
      day. Delirium causes increased morbidity and mortality, decreased postoperative functional&#xD;
      activity and may predispose to dementia.&#xD;
&#xD;
      Perioperative pain may be an important predisposing factor to delirium. Intravenous opioids&#xD;
      have been widely used to relieve patients with hip fracture from pain, but they have a lot of&#xD;
      complications and have been correlated with delirium as well. Fascia Iliaca compartment block&#xD;
      is a peripheral compartment nerve block that is used in hip surgeries. Use of this&#xD;
      compartment nerve block to protect geriatric patients from delirium has not been studied.&#xD;
&#xD;
      The objective of this trial will be to establish whether the ultrasound-guided suprainguinal&#xD;
      fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture&#xD;
      from delirium as compared to placebo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain score 30 minutes after fascia iliaca block</measure>
    <time_frame>30 minutes after performance of fascia iliaca block</time_frame>
    <description>pain score by the use of Numeric Rating Scale (NRS) 30 minutes after fascia ilaca block, ranging from 0 to 10, where 0 means &quot;no pain&quot; and 10 means &quot;worst pain imaginable&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain score 12 hours after fascia iliaca block</measure>
    <time_frame>12 hours after performance of fascia iliaca block</time_frame>
    <description>pain score by the use of Numeric Rating Scale (NRS) 12 hours after fascia ilaca block, ranging from 0 to 10, where 0 means &quot;no pain&quot; and 10 means &quot;worst pain imaginable&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain score 1-8 days after fascia iliaca block</measure>
    <time_frame>1-8 days after fascia iliaca block</time_frame>
    <description>pain score by the use of Numeric Rating Scale (NRS) 1-8 days after fascia ilaca block, ranging from 0 to 10, where 0 means &quot;no pain&quot; and 10 means &quot;worst pain imaginable&quot;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mini Mental State examination</measure>
    <time_frame>arrival to the emergency room</time_frame>
    <description>Mini Mental State examination on arrival to the emergency room</description>
  </other_outcome>
  <other_outcome>
    <measure>Mini Mental State examination</measure>
    <time_frame>1-8 days postoperatively</time_frame>
    <description>Mini Mental State examination postoperatively</description>
  </other_outcome>
  <other_outcome>
    <measure>Confusion Assessment Method</measure>
    <time_frame>arrival to the emergency room</time_frame>
    <description>Confusion Assessment Method on arrival to the emergency room</description>
  </other_outcome>
  <other_outcome>
    <measure>Confusion Assessment Method</measure>
    <time_frame>1-8 days postoperatively</time_frame>
    <description>Confusion Assessment Method postoperatively</description>
  </other_outcome>
  <other_outcome>
    <measure>requests for analgesia</measure>
    <time_frame>1-8 days postoperatively</time_frame>
    <description>requests for analgesia postoperatively</description>
  </other_outcome>
  <other_outcome>
    <measure>tramadol consumption</measure>
    <time_frame>1-8 days postoperatively</time_frame>
    <description>tramadol consumption postoperatively</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Delirium</condition>
  <condition>Delirium in Old Age</condition>
  <condition>Hip Fractures</condition>
  <condition>Dementia</condition>
  <condition>Pain</condition>
  <condition>Analgesia</condition>
  <condition>Mental Status Change</condition>
  <arm_group>
    <arm_group_label>fascia iliaca compartment block with ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fascia iliaca compartment block with placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fascia iliaca compartment block with ropivacaine</intervention_name>
    <description>the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of ropivacaine 0.25%)</description>
    <arm_group_label>fascia iliaca compartment block with ropivacaine</arm_group_label>
    <other_name>medication in regional anesthetic technique</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fascia iliaca compartment block with placebo</intervention_name>
    <description>the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of normal saline)</description>
    <arm_group_label>fascia iliaca compartment block with placebo</arm_group_label>
    <other_name>medication in regional anesthetic technique</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  geriatric patients&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) I-III&#xD;
&#xD;
          -  hip fracture patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  communication or language barriers&#xD;
&#xD;
          -  patients with nutritional problems&#xD;
&#xD;
          -  bedridden patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kassiani Theodoraki, PhD, DESA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aretaieion University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kassiani Theodoraki, PhD, DESA</last_name>
    <phone>+306974634162</phone>
    <email>ktheodoraki@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Krystallia Vitoula, MD</last_name>
    <email>kvitoula@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>KAT General Hospital of Athens</name>
      <address>
        <city>Kifisiá</city>
        <zip>14561</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kassiani Theodoraki, Phd, DESA</last_name>
      <phone>+306974634162</phone>
      <email>ktheodoraki@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Krystallia vitoula, MD</last_name>
      <email>kvitoula@yahoo.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Unneby A, Svensson PO, Gustafson PY, Lindgren APB, Bergstrom U, Olofsson PB. Complications with focus on delirium during hospital stay related to femoral nerve block compared to conventional pain management among patients with hip fracture - A randomised controlled trial. Injury. 2020 Jul;51(7):1634-1641. doi: 10.1016/j.injury.2020.04.013. Epub 2020 Apr 20.</citation>
    <PMID>32360090</PMID>
  </reference>
  <reference>
    <citation>Zhao X, Yuan W. Perioperative Multicomponent Interdisciplinary Program Reduces Delirium Incidence in Elderly Patients With Hip Fracture. J Am Psychiatr Nurses Assoc. 2022 Mar;28(2):154-163. doi: 10.1177/1078390320915250. Epub 2020 Apr 13.</citation>
    <PMID>32281905</PMID>
  </reference>
  <reference>
    <citation>Poeran J, Cozowicz C, Zubizarreta N, Weinstein SM, Deiner SG, Leipzig RM, Friedman JI, Liu J, Mazumdar M, Memtsoudis SG. Modifiable factors associated with postoperative delirium after hip fracture repair: An age-stratified retrospective cohort study. Eur J Anaesthesiol. 2020 Aug;37(8):649-658. doi: 10.1097/EJA.0000000000001197.</citation>
    <PMID>32251149</PMID>
  </reference>
  <reference>
    <citation>Uysal AI, Altiparmak B, Yasar E, Turan M, Canbek U, Yilmaz N, Gumus Demirbilek S. The effects of early femoral nerve block intervention on preoperative pain management and incidence of postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery: A randomized controlled trial. Ulus Travma Acil Cerrahi Derg. 2020 Jan;26(1):109-114. doi: 10.14744/tjtes.2019.78002.</citation>
    <PMID>31942744</PMID>
  </reference>
  <reference>
    <citation>Scurrah A, Shiner CT, Stevens JA, Faux SG. Regional nerve blockade for early analgesic management of elderly patients with hip fracture - a narrative review. Anaesthesia. 2018 Jun;73(6):769-783. doi: 10.1111/anae.14178. Epub 2017 Dec 26.</citation>
    <PMID>29278266</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 10, 2022</last_update_submitted>
  <last_update_submitted_qc>July 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aretaieion University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Kassiani Theodoraki</investigator_full_name>
    <investigator_title>Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
    <mesh_term>Fractures, Bone</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>Ropivacaine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04404959
org study id: Delirium-Pain-Hip Fracture
nct id: NCT04404959
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this trial will be to establish whether the ultrasound-guided suprainguinal
      fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture
      from delirium as compared to placebo
Geriatric patients suffer from hip fractures very often. Delirium is a perioperative
      neuropsychiatric complication that is characterized by sudden change of mental status,
      inattention, disorientation and memory impairment with fluctuations of symptoms during the
      day. Delirium causes increased morbidity and mortality, decreased postoperative functional
      activity and may predispose to dementia.

      Perioperative pain may be an important predisposing factor to delirium. Intravenous opioids
      have been widely used to relieve patients with hip fracture from pain, but they have a lot of
      complications and have been correlated with delirium as well. Fascia Iliaca compartment block
      is a peripheral compartment nerve block that is used in hip surgeries. Use of this
      compartment nerve block to protect geriatric patients from delirium has not been studied.

      The objective of this trial will be to establish whether the ultrasound-guided suprainguinal
      fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture
      from delirium as compared to placebo
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: pain score 30 minutes after fascia iliaca block
time frame: 30 minutes after performance of fascia iliaca block
description: pain score by the use of Numeric Rating Scale (NRS) 30 minutes after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
measure: pain score 12 hours after fascia iliaca block
time frame: 12 hours after performance of fascia iliaca block
description: pain score by the use of Numeric Rating Scale (NRS) 12 hours after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
measure: pain score 1-8 days after fascia iliaca block
time frame: 1-8 days after fascia iliaca block
description: pain score by the use of Numeric Rating Scale (NRS) 1-8 days after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"
measure: Mini Mental State examination
time frame: arrival to the emergency room
description: Mini Mental State examination on arrival to the emergency room
measure: Mini Mental State examination
time frame: 1-8 days postoperatively
description: Mini Mental State examination postoperatively
measure: Confusion Assessment Method
time frame: arrival to the emergency room
description: Confusion Assessment Method on arrival to the emergency room
measure: Confusion Assessment Method
time frame: 1-8 days postoperatively
description: Confusion Assessment Method postoperatively
measure: requests for analgesia
time frame: 1-8 days postoperatively
description: requests for analgesia postoperatively
measure: tramadol consumption
time frame: 1-8 days postoperatively
description: tramadol consumption postoperatively
arm group label: fascia iliaca compartment block with ropivacaine
arm group type: Active Comparator
description: in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%
arm group label: fascia iliaca compartment block with placebo
arm group type: Placebo Comparator
description: in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline
intervention type: Other
intervention name: fascia iliaca compartment block with ropivacaine
description: the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of ropivacaine 0.25%)
arm group label: fascia iliaca compartment block with ropivacaine
other name: medication in regional anesthetic technique
intervention type: Other
intervention name: fascia iliaca compartment block with placebo
description: the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of normal saline)
arm group label: fascia iliaca compartment block with placebo
other name: medication in regional anesthetic technique
criteria: 
gender: All
minimum age: 75 Years
maximum age: 105 Years
healthy volunteers: No
last name: Kassiani Theodoraki, PhD, DESA
role: Principal Investigator
affiliation: Aretaieion University Hospital
last name: Kassiani Theodoraki, PhD, DESA
phone: +306974634162
email: ktheodoraki@hotmail.com
last name: Krystallia Vitoula, MD
email: kvitoula@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Greece
citation: Unneby A, Svensson PO, Gustafson PY, Lindgren APB, Bergstrom U, Olofsson PB. Complications with focus on delirium during hospital stay related to femoral nerve block compared to conventional pain management among patients with hip fracture - A randomised controlled trial. Injury. 2020 Jul;51(7):1634-1641. doi: 10.1016/j.injury.2020.04.013. Epub 2020 Apr 20.
PMID: 32360090
citation: Zhao X, Yuan W. Perioperative Multicomponent Interdisciplinary Program Reduces Delirium Incidence in Elderly Patients With Hip Fracture. J Am Psychiatr Nurses Assoc. 2022 Mar;28(2):154-163. doi: 10.1177/1078390320915250. Epub 2020 Apr 13.
PMID: 32281905
citation: Poeran J, Cozowicz C, Zubizarreta N, Weinstein SM, Deiner SG, Leipzig RM, Friedman JI, Liu J, Mazumdar M, Memtsoudis SG. Modifiable factors associated with postoperative delirium after hip fracture repair: An age-stratified retrospective cohort study. Eur J Anaesthesiol. 2020 Aug;37(8):649-658. doi: 10.1097/EJA.0000000000001197.
PMID: 32251149
citation: Uysal AI, Altiparmak B, Yasar E, Turan M, Canbek U, Yilmaz N, Gumus Demirbilek S. The effects of early femoral nerve block intervention on preoperative pain management and incidence of postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery: A randomized controlled trial. Ulus Travma Acil Cerrahi Derg. 2020 Jan;26(1):109-114. doi: 10.14744/tjtes.2019.78002.
PMID: 31942744
citation: Scurrah A, Shiner CT, Stevens JA, Faux SG. Regional nerve blockade for early analgesic management of elderly patients with hip fracture - a narrative review. Anaesthesia. 2018 Jun;73(6):769-783. doi: 10.1111/anae.14178. Epub 2017 Dec 26.
PMID: 29278266
responsible party type: Principal Investigator
investigator affiliation: Aretaieion University Hospital
investigator full name: Dr Kassiani Theodoraki
investigator title: Professor of Anesthesiology
mesh term: Delirium
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Ropivacaine
mesh term: Anesthetics