<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/NCT04478552</url>
  </required_header>
  <id_info>
    <org_study_id>SPv1</org_study_id>
    <nct_id>NCT04478552</nct_id>
  </id_info>
  <brief_title>Analgesic Effect of Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture</brief_title>
  <official_title>Randomized Controlled Trial on Analgesic Effect of Pre-operative Fascia Iliaca Compartment Block in Geriatric Patients With Hip Fracture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United Christian Hospital</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>
      As population in Hong Kong is aging, incidence of geriatrics hip fractures rises. Operative&#xD;
      treatment for selective patients offers pain control, early mobilization and reduction in&#xD;
      medical morbidities and mortalities. Research has shown that the pain from hip fracture left&#xD;
      untreated may have significant physical and psychological effects on the patient,&#xD;
      precipitating delirium, especially in elderly patients with hip fractures, and may delay&#xD;
      operative management and may complicate hospital stay. Studies report that the pain&#xD;
      management for limb fractures in the elderly is hugely sub-optimal with some suggesting that&#xD;
      only 2% receive adequate analgesia. Adequate analgesia before definitive treatment of hip&#xD;
      fracture may improve mobilization and cognitive performance. As a part of multi-modal pain&#xD;
      management, Fascia iliaca compartment block is being increasingly popular as a simple, safe&#xD;
      and effective regional technique for patients with hip fractures and proximal femoral shaft&#xD;
      fractures, providing consistent analgesic effect for hip fracture patients, irrespective of&#xD;
      the performing doctor's experience. This study aims to provide high level local evidence of&#xD;
      the effect and efficacy of the fascia iliaca compartment block in preoperative pain control&#xD;
      for patients with hip fracture admitted to Orthopaedic and Traumatology ward in United&#xD;
      Christian Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized control, single blinded trial. It tests the hypothesis that fascia&#xD;
      iliaca compartment block using local anaesthetic agent for pre-operative analgesia in&#xD;
      patients with hip fracture, compared to that using normal saline as control, leads to a&#xD;
      better pain control and fewer doses of systemic analgesics required. All patients admitted to&#xD;
      United Christian Hospital Orthopaedic and Traumatology ward for hip fracture with&#xD;
      radiological diagnosis will be seen by on-call resident. Principal investigator and other&#xD;
      investigators will be notified of the admission within 1 working day. Subjects will be&#xD;
      recruited according to inclusion and exclusion criteria as mentioned in the below section.&#xD;
      Subjects will be recruited only if an informed consent for this study has been signed. Only&#xD;
      patients with hip fracture pending emergency operation will be recruited. 2 enclosed&#xD;
      envelopes will be prepared, in which one indicates &quot;intervention&quot;, and one indicates&#xD;
      &quot;control&quot;. Subjects will randomly choose any of the envelopes without knowing the&#xD;
      intervention/control group assignment. To maintain true randomization, the 2 envelopes will&#xD;
      be kept in good condition, preventing identification of the underlying assignment from the&#xD;
      outer appearance. Investigators, knowing the group assignment, will then prepare an injection&#xD;
      kit set for Fascia iliaca compartment block which includes vials of levobupivacaine, normal&#xD;
      saline, syringes, 22G/21G needle, simple dressing set and skin antiseptic solution. For the&#xD;
      intervention group, fascia iliaca compartment block with 30ml/40ml 0.25% levobupivacaine,&#xD;
      depending on body weight (30ml for body weight less than 50kg, 40ml for body weight more than&#xD;
      50kg), will be performed by investigators under landmark approach. For the control group,&#xD;
      same volume of normal saline, instead of levobupivacaine, will injected using the same&#xD;
      technique, so that single blinding can be achieved. Subjects' vital signs will be observed&#xD;
      for every 10 minutes for 30 minutes after injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">October 14, 2021</completion_date>
  <primary_completion_date type="Actual">September 14, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain in terms of Numeric Rating Scale</measure>
    <time_frame>on admission, just before fascia iliaca compartment block, 1 hour after injection, 12 hour after injection, 24 hour after injection, and 48 hour after injection.</time_frame>
    <description>Numeric Rating Scale (0-10) whereas 0 is the least pain and 10 is the worst pain</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fascia iliaca compartment block</intervention_name>
    <description>It involves injecting local anaesthetic agent (levobupivacaine) into the fascia iliaca compartment of the patient, infiltrating three major nerves that supply the medial, anterior and lateral thigh, namely the femoral and lateral femoral cutaneous nerves. This procedure can be done with anatomical landmark approach or under image guidance.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo injection</intervention_name>
    <description>same volume of normal saline, instead of levobupivacaine, will injected using the same technique.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 or above&#xD;
&#xD;
          -  Patients admitted Orthopaedic and Traumatology ward in United Christian Hospital&#xD;
&#xD;
          -  Radiographically confirmed unilateral fracture hip&#xD;
&#xD;
          -  Patient requiring pre-operative analgesia&#xD;
&#xD;
          -  Mentally competent&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 65&#xD;
&#xD;
          -  Presence of more than one fracture&#xD;
&#xD;
          -  Patient refusal to participating in this study&#xD;
&#xD;
          -  Known true allergy or previous anaphylactic reaction to local anaesthetic&#xD;
&#xD;
          -  Previous femoral-bypass surgery, or near a graft site.&#xD;
&#xD;
          -  Previous surgery over the injection site&#xD;
&#xD;
          -  Inflammation, infection, or hernia over the injection site&#xD;
&#xD;
          -  INR &gt;1.4&#xD;
&#xD;
          -  Platelet count &lt;100x 10^9/L&#xD;
&#xD;
          -  Patient on heparin / fondaparinux / rivaroxaban / dabigatran / ticlopidine /&#xD;
             clopidogrel / prasugrel / cilostazol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>United Christian Hospital</name>
      <address>
        <city>Kwun Tong</city>
        <state>Kowloon</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>March 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>May 21, 2023</last_update_submitted>
  <last_update_submitted_qc>May 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>United Christian Hospital</investigator_affiliation>
    <investigator_full_name>Wan Tze Kit</investigator_full_name>
    <investigator_title>Dr Wan Tze Kit</investigator_title>
  </responsible_party>
  <keyword>hip fracture</keyword>
  <keyword>orthogeriatrics</keyword>
  <keyword>fascia iliaca compartment block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <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>


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/NCT04478552
org study id: SPv1
nct id: NCT04478552
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
As population in Hong Kong is aging, incidence of geriatrics hip fractures rises. Operative
      treatment for selective patients offers pain control, early mobilization and reduction in
      medical morbidities and mortalities. Research has shown that the pain from hip fracture left
      untreated may have significant physical and psychological effects on the patient,
      precipitating delirium, especially in elderly patients with hip fractures, and may delay
      operative management and may complicate hospital stay. Studies report that the pain
      management for limb fractures in the elderly is hugely sub-optimal with some suggesting that
      only 2% receive adequate analgesia. Adequate analgesia before definitive treatment of hip
      fracture may improve mobilization and cognitive performance. As a part of multi-modal pain
      management, Fascia iliaca compartment block is being increasingly popular as a simple, safe
      and effective regional technique for patients with hip fractures and proximal femoral shaft
      fractures, providing consistent analgesic effect for hip fracture patients, irrespective of
      the performing doctor's experience. This study aims to provide high level local evidence of
      the effect and efficacy of the fascia iliaca compartment block in preoperative pain control
      for patients with hip fracture admitted to Orthopaedic and Traumatology ward in United
      Christian Hospital.
This study is a randomized control, single blinded trial. It tests the hypothesis that fascia
      iliaca compartment block using local anaesthetic agent for pre-operative analgesia in
      patients with hip fracture, compared to that using normal saline as control, leads to a
      better pain control and fewer doses of systemic analgesics required. All patients admitted to
      United Christian Hospital Orthopaedic and Traumatology ward for hip fracture with
      radiological diagnosis will be seen by on-call resident. Principal investigator and other
      investigators will be notified of the admission within 1 working day. Subjects will be
      recruited according to inclusion and exclusion criteria as mentioned in the below section.
      Subjects will be recruited only if an informed consent for this study has been signed. Only
      patients with hip fracture pending emergency operation will be recruited. 2 enclosed
      envelopes will be prepared, in which one indicates "intervention", and one indicates
      "control". Subjects will randomly choose any of the envelopes without knowing the
      intervention/control group assignment. To maintain true randomization, the 2 envelopes will
      be kept in good condition, preventing identification of the underlying assignment from the
      outer appearance. Investigators, knowing the group assignment, will then prepare an injection
      kit set for Fascia iliaca compartment block which includes vials of levobupivacaine, normal
      saline, syringes, 22G/21G needle, simple dressing set and skin antiseptic solution. For the
      intervention group, fascia iliaca compartment block with 30ml/40ml 0.25% levobupivacaine,
      depending on body weight (30ml for body weight less than 50kg, 40ml for body weight more than
      50kg), will be performed by investigators under landmark approach. For the control group,
      same volume of normal saline, instead of levobupivacaine, will injected using the same
      technique, so that single blinding can be achieved. Subjects' vital signs will be observed
      for every 10 minutes for 30 minutes after injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in pain in terms of Numeric Rating Scale
time frame: on admission, just before fascia iliaca compartment block, 1 hour after injection, 12 hour after injection, 24 hour after injection, and 48 hour after injection.
description: Numeric Rating Scale (0-10) whereas 0 is the least pain and 10 is the worst pain
arm group label: Intervention group
arm group type: Experimental
arm group label: Control group
arm group type: Placebo Comparator
intervention type: Procedure
intervention name: Fascia iliaca compartment block
description: It involves injecting local anaesthetic agent (levobupivacaine) into the fascia iliaca compartment of the patient, infiltrating three major nerves that supply the medial, anterior and lateral thigh, namely the femoral and lateral femoral cutaneous nerves. This procedure can be done with anatomical landmark approach or under image guidance.
arm group label: Intervention group
intervention type: Procedure
intervention name: Placebo injection
description: same volume of normal saline, instead of levobupivacaine, will injected using the same technique.
arm group label: Control group
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: United Christian Hospital
investigator full name: Wan Tze Kit
investigator title: Dr Wan Tze Kit
mesh term: Fractures, Bone
mesh term: Hip Fractures
sharing ipd: No