<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/NCT02983344</url>
  </required_header>
  <id_info>
    <org_study_id>NMRR-15-757-25608</org_study_id>
    <nct_id>NCT02983344</nct_id>
  </id_info>
  <brief_title>Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia</brief_title>
  <official_title>Analgesia For Positioning Patient With Femur Fracture For Spinal Anaesthesia : Ultrasound-Guided Fascia Iliaca Compartment Block Versus Intravenous Fentanyl</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kuala Lumpur General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universiti Kebangsaan Malaysia Medical Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kuala Lumpur General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is performed to determine the efficacy of ultrasound-guided fascia iliaca&#xD;
      compartment block during positioning for spinal anaesthesia in patient undergoing repair of&#xD;
      proximal femur fracture surgery comparing with intravenous fentanyl.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This a prospective, single-blind, randomized control study that compare the efficacy of&#xD;
      ultrasound-guided fascia iliaca compartment block with intravenous fentanyl in positioning&#xD;
      patient with femur fracture for spinal anaesthesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score during positioning</measure>
    <time_frame>Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)</time_frame>
    <description>Pain score is assessed using Visual Analogue Scale (VAS) score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of positioning for spinal anaesthesia</measure>
    <time_frame>Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)</time_frame>
    <description>It will be characterized as 'very difficult', 'difficult', 'easy' and 'very easy'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>24 hours after intervention</time_frame>
    <description>Patient will be asked whether they will choose the same analgesic technique in the event of future operation : 'yes' or 'no'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>Up to 24 hours of intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Femoral Fracture</condition>
  <arm_group>
    <arm_group_label>fascia iliaca compartment block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive 40ml of ropivacaine 0.375% at the fascia iliaca compartment under the guidance of ultrasound. It will be given 20 minutes before patient is positioned for spinal anaesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intravenous fentanyl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Fascia iliaca compartment block using ropivacaine</description>
    <arm_group_label>fascia iliaca compartment block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>Intravenous fentanyl</description>
    <arm_group_label>intravenous fentanyl</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound-guided fascia iliaca compartment block</description>
    <arm_group_label>fascia iliaca compartment block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) score I and II&#xD;
&#xD;
          -  Elective surgery of repair of unilateral, single femoral fracture under spinal&#xD;
             anaesthesia performed in General Operation Theatre, Hospital Kuala Lumpur. The&#xD;
             fracture may involve femoral neck or femoral shaft.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with contraindication for spinal anaesthesia&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to medication used in this study&#xD;
&#xD;
          -  Morbid obesity (body mass index (BMI) &gt; 35 kg/m2)&#xD;
&#xD;
          -  Infection at the intended site of administration of fascia iliaca compartment block&#xD;
&#xD;
          -  Patient with impaired cognitive function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raha Abdul Rahman, MBBS</last_name>
    <role>Study Chair</role>
    <affiliation>Universiti Kebangsaan Malaysia Medical Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azrin Mohd Azidin, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kuala Lumpur General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kuala Lumpur General Hospital</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan</state>
        <zip>50586</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <results_reference>
    <citation>Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.</citation>
    <PMID>25068412</PMID>
  </results_reference>
  <results_reference>
    <citation>Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22.</citation>
    <PMID>19650803</PMID>
  </results_reference>
  <results_reference>
    <citation>Newman B, McCarthy L, Thomas PW, May P, Layzell M, Horn K. A comparison of pre-operative nerve stimulator-guided femoral nerve block and fascia iliaca compartment block in patients with a femoral neck fracture. Anaesthesia. 2013 Sep;68(9):899-903. doi: 10.1111/anae.12321. Epub 2013 Jun 21.</citation>
    <PMID>23789738</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kuala Lumpur General Hospital</investigator_affiliation>
    <investigator_full_name>Dr Aida Mastura Mohd Shah</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>fascia iliaca compartment block</keyword>
  <keyword>fentanyl</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral 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>Ropivacaine</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/NCT02983344
org study id: NMRR-15-757-25608
nct id: NCT02983344
lead sponsor: 
collaborator: 
has dmc: No
This study is performed to determine the efficacy of ultrasound-guided fascia iliaca
      compartment block during positioning for spinal anaesthesia in patient undergoing repair of
      proximal femur fracture surgery comparing with intravenous fentanyl.
This a prospective, single-blind, randomized control study that compare the efficacy of
      ultrasound-guided fascia iliaca compartment block with intravenous fentanyl in positioning
      patient with femur fracture for spinal anaesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain score during positioning
time frame: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
description: Pain score is assessed using Visual Analogue Scale (VAS) score
measure: Ease of positioning for spinal anaesthesia
time frame: Group 1: 20 minutes after intervention (block), Group 2: 5 minutes after intervention (fentanyl)
description: It will be characterized as 'very difficult', 'difficult', 'easy' and 'very easy'
measure: Patient satisfaction
time frame: 24 hours after intervention
description: Patient will be asked whether they will choose the same analgesic technique in the event of future operation : 'yes' or 'no'.
measure: Adverse effects
time frame: Up to 24 hours of intervention
arm group label: fascia iliaca compartment block
arm group type: Active Comparator
description: Patient will receive 40ml of ropivacaine 0.375% at the fascia iliaca compartment under the guidance of ultrasound. It will be given 20 minutes before patient is positioned for spinal anaesthesia
arm group label: intravenous fentanyl
arm group type: Active Comparator
description: Patient will receive 0.5 mcg/kg of intravenous fentanyl. It will be given 5 minutes before patient is positioned for spinal anaesthesia
intervention type: Drug
intervention name: Ropivacaine
description: Fascia iliaca compartment block using ropivacaine
arm group label: fascia iliaca compartment block
intervention type: Drug
intervention name: Fentanyl
description: Intravenous fentanyl
arm group label: intravenous fentanyl
intervention type: Device
intervention name: Ultrasound
description: Ultrasound-guided fascia iliaca compartment block
arm group label: fascia iliaca compartment block
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Raha Abdul Rahman, MBBS
role: Study Chair
affiliation: Universiti Kebangsaan Malaysia Medical Centre
last name: Azrin Mohd Azidin, MBBS
role: Principal Investigator
affiliation: Kuala Lumpur General Hospital
facility: 
country: Malaysia
citation: Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.
PMID: 25068412
citation: Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22.
PMID: 19650803
citation: Newman B, McCarthy L, Thomas PW, May P, Layzell M, Horn K. A comparison of pre-operative nerve stimulator-guided femoral nerve block and fascia iliaca compartment block in patients with a femoral neck fracture. Anaesthesia. 2013 Sep;68(9):899-903. doi: 10.1111/anae.12321. Epub 2013 Jun 21.
PMID: 23789738
responsible party type: Principal Investigator
investigator affiliation: Kuala Lumpur General Hospital
investigator full name: Dr Aida Mastura Mohd Shah
investigator title: Principle Investigator
mesh term: Fractures, Bone
mesh term: Femoral Fractures
mesh term: Fentanyl
mesh term: Ropivacaine