<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/NCT03794427</url>
  </required_header>
  <id_info>
    <org_study_id>181218</org_study_id>
    <nct_id>NCT03794427</nct_id>
  </id_info>
  <brief_title>Combined Lumbosacral Nerve Block Versus Spinal Anesthesia for Cognitive Function After Hip Prothesis</brief_title>
  <official_title>Cognitive Changes After Hip Prosthesis; Comparison Between Combined Lumbosacral Nerve Block Versus Spinal Anesthesia: a Double Blind Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Makassed General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Makassed General Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hip fracture is a potentially devastating event, and serious surgical and medical&#xD;
      complications occur frequently especially for elderly patients. Delirium is one of the common&#xD;
      complications after hip surgery. Controversy exists regarding the possible impact of type of&#xD;
      anesthesia (nerve block versus spinal) upon acute and long-term cognitive decline.&#xD;
&#xD;
      The primary objective is to assess the association between type of anesthesia (nerve block&#xD;
      vs. spinal anesthesia) and risk of cognitive decline (CD). The secondary objective is to&#xD;
      compare intra-operative hemodynamic changes, use of vasopressor drugs, and use of&#xD;
      post-operative analgesics with respect to the type of anesthesia.&#xD;
&#xD;
      Prospective, double blind randomized clinical trial of hip fracture patients who will be&#xD;
      assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The&#xD;
      presence of CD will be determined at follow-up evaluation up to three months after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, double blind randomized clinical trial of hip fracture patients who will be&#xD;
      assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The&#xD;
      presence of CD will be determined at follow-up evaluation up to three months after surgery.&#xD;
      Patients undergoing hip surgery will be randomized into two groups. Group 1 will receive&#xD;
      unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels&#xD;
      L3-L4 and L4-L5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia&#xD;
      level (L3-L4 or L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture&#xD;
      whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture&#xD;
      without exceeding the maximum injected volume of 1 ml/kg. Group 2 will receive spinal&#xD;
      anesthesia (3 ml of 0.5% bupivacaine) in addition to placebo injection at the sciatic, L3-L4&#xD;
      and L4-L5 levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">April 2022</completion_date>
  <primary_completion_date type="Anticipated">April 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>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive decline</measure>
    <time_frame>before operation (baseline)</time_frame>
    <description>Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive decline</measure>
    <time_frame>1 day after the operation</time_frame>
    <description>Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive decline</measure>
    <time_frame>7 days after the operation</time_frame>
    <description>Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive decline</measure>
    <time_frame>1 month after the operation</time_frame>
    <description>Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive decline</measure>
    <time_frame>2 months after the operation</time_frame>
    <description>Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cognitive decline</measure>
    <time_frame>3 months after operation</time_frame>
    <description>Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-operative hemodynamic changes</measure>
    <time_frame>1 minute intra-operative</time_frame>
    <description>Mean arterial pressure (in mmHg) will be recorded through a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-operative hemodynamic changes</measure>
    <time_frame>5 minutes intra-operative</time_frame>
    <description>Mean arterial pressure (in mmHg) will be recorded through a questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-operative hemodynamic changes</measure>
    <time_frame>every 10 minutes intra-operative</time_frame>
    <description>Mean arterial pressure (in mmHg) will be recorded through a questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>unilateral lumbosacral nerve block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spinal anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>spinal anesthesia will be performed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>unilateral lumbosacral nerve block</intervention_name>
    <description>Patients will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg.</description>
    <arm_group_label>unilateral lumbosacral nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Spinal anesthesia</intervention_name>
    <description>Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)</description>
    <arm_group_label>Spinal anesthesia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo at the spinal anesthesia level</intervention_name>
    <description>Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).</description>
    <arm_group_label>unilateral lumbosacral nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo at lumbosacral level</intervention_name>
    <description>Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels</description>
    <arm_group_label>Spinal anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric)&#xD;
&#xD;
          -  40 kg in weight and higher&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who are:&#xD;
&#xD;
          -  Uncooperative&#xD;
&#xD;
          -  Considered as moribund by the orthopedic surgeon at admission&#xD;
&#xD;
          -  Alzheimer&#xD;
&#xD;
          -  Severe cognitive impairment (MMSE&lt;18)&#xD;
&#xD;
          -  Absolute contraindication for spinal anesthesia (assessed preoperatively)&#xD;
&#xD;
          -  Allergy to local anesthesia&#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>Zoher Naja</last_name>
    <role>Principal Investigator</role>
    <affiliation>Makassed General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zoher Naja</last_name>
    <phone>+9611636000</phone>
    <phone_ext>6405</phone_ext>
    <email>zouhnaja@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Makassed General Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zoher Naja, MD</last_name>
      <phone>+9611636000</phone>
      <phone_ext>6941</phone_ext>
      <email>zouhnaja@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 25, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Makassed General Hospital</investigator_affiliation>
    <investigator_full_name>Zoher Naja</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03794427
org study id: 181218
nct id: NCT03794427
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hip fracture is a potentially devastating event, and serious surgical and medical
      complications occur frequently especially for elderly patients. Delirium is one of the common
      complications after hip surgery. Controversy exists regarding the possible impact of type of
      anesthesia (nerve block versus spinal) upon acute and long-term cognitive decline.

      The primary objective is to assess the association between type of anesthesia (nerve block
      vs. spinal anesthesia) and risk of cognitive decline (CD). The secondary objective is to
      compare intra-operative hemodynamic changes, use of vasopressor drugs, and use of
      post-operative analgesics with respect to the type of anesthesia.

      Prospective, double blind randomized clinical trial of hip fracture patients who will be
      assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The
      presence of CD will be determined at follow-up evaluation up to three months after surgery.
Prospective, double blind randomized clinical trial of hip fracture patients who will be
      assessed for CD pre- and postoperatively, using the Mini Mental State Examination (MMSE). The
      presence of CD will be determined at follow-up evaluation up to three months after surgery.
      Patients undergoing hip surgery will be randomized into two groups. Group 1 will receive
      unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels
      L3-L4 and L4-L5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia
      level (L3-L4 or L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture
      whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture
      without exceeding the maximum injected volume of 1 ml/kg. Group 2 will receive spinal
      anesthesia (3 ml of 0.5% bupivacaine) in addition to placebo injection at the sciatic, L3-L4
      and L4-L5 levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Cognitive decline
time frame: before operation (baseline)
description: Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
measure: Cognitive decline
time frame: 1 day after the operation
description: Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
measure: Cognitive decline
time frame: 7 days after the operation
description: Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
measure: Cognitive decline
time frame: 1 month after the operation
description: Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
measure: Cognitive decline
time frame: 2 months after the operation
description: Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
measure: Cognitive decline
time frame: 3 months after operation
description: Patients' cognitive function will be assessed using the Mini Mental State Examination. The total score ranges between 0 and 30. A total score between 24 and 30 indicates no cognitive impairment. A score between 18 and 23 indicates mild cognitive impairment. A score between 0 and 17 indicates severe cognitive impairment
measure: Intra-operative hemodynamic changes
time frame: 1 minute intra-operative
description: Mean arterial pressure (in mmHg) will be recorded through a questionnaire
measure: Intra-operative hemodynamic changes
time frame: 5 minutes intra-operative
description: Mean arterial pressure (in mmHg) will be recorded through a questionnaire
measure: Intra-operative hemodynamic changes
time frame: every 10 minutes intra-operative
description: Mean arterial pressure (in mmHg) will be recorded through a questionnaire
arm group label: unilateral lumbosacral nerve block
arm group type: Experimental
description: Sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5 will be performed
arm group label: Spinal anesthesia
arm group type: Active Comparator
description: spinal anesthesia will be performed
intervention type: Other
intervention name: unilateral lumbosacral nerve block
description: Patients will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg.
arm group label: unilateral lumbosacral nerve block
intervention type: Other
intervention name: Spinal anesthesia
description: Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
arm group label: Spinal anesthesia
intervention type: Other
intervention name: Placebo at the spinal anesthesia level
description: Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
arm group label: unilateral lumbosacral nerve block
intervention type: Other
intervention name: Placebo at lumbosacral level
description: Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels
arm group label: Spinal anesthesia
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Zoher Naja
role: Principal Investigator
affiliation: Makassed General Hospital
last name: Zoher Naja
phone: +9611636000
phone ext: 6405
email: zouhnaja@yahoo.com
facility: 
status: Recruiting
contact: 
country: Lebanon
responsible party type: Principal Investigator
investigator affiliation: Makassed General Hospital
investigator full name: Zoher Naja
investigator title: Anesthesiologist
mesh term: Cognitive Dysfunction
mesh term: Anesthetics