<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/NCT04506450</url>
  </required_header>
  <id_info>
    <org_study_id>721</org_study_id>
    <nct_id>NCT04506450</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery</brief_title>
  <official_title>Peripheral Nerve Block vs Spinal Anesthesia in Hip Surgery: a Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università Politecnica delle Marche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università Politecnica delle Marche</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>
      Anesthesia plays an important role in the patient's outcome: each anesthesiological technique&#xD;
      has a different cardiovascular impact, because they act differently on the autonomic nervous&#xD;
      system, which in turn regulates heart rate, myocardial contractility and vascular tone.&#xD;
&#xD;
      Subarachnoid anesthesia can result in a reduction in cardiac output, hypotension and&#xD;
      bradycardia due to blockage of the nerve fibers of the sympathetic system, while peripheral&#xD;
      nerve block is associated with a lower impact on the autonomic nervous system, therefore less&#xD;
      influence on hemodynamic changes compared to subarachnoid anesthesia.&#xD;
&#xD;
      Hypotension can lead to myocardial ischaemia, especially in patients at high surgical risk.&#xD;
&#xD;
      In addition, peripheral nerve block allows for better coverage from postoperative pain&#xD;
      compared to subarachnoid anesthesia in patients undergoing hip surgery.&#xD;
&#xD;
      This leads to less postoperative stress, with less impact on cardiac and respiratory&#xD;
      function.&#xD;
&#xD;
      Numerous studies have shown the efficacy and safety of regional anesthesia in hip surgery.&#xD;
&#xD;
      This study aims to compare the hemodynamic changes of subarachnoid anesthesia and peripheral&#xD;
      nerve block in patients who underwent total and partial hip replacement&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients who meet the inclusion and exclusion criteria will be enrolled. Enrolled&#xD;
      patients will be informed of the study modality. In case of a favorable opinion, the patient&#xD;
      will be made to sign the informed consent. Subsequently a code will be assigned to the&#xD;
      patient for randomization.&#xD;
&#xD;
      There are two randomization groups: in the PNB group the patient will undergo lumbar plexus&#xD;
      block, sciatic nerve block, lateral femoral cutaneous nerve block and lateral branch of&#xD;
      iliohypogastric nerve block, while in the SA group, the patient will undergo subarachnoid&#xD;
      anesthesia and lumbar plexus block.&#xD;
&#xD;
      In the preoperative room, ECG, pulseoximetry will be estabilished and an arterial radial&#xD;
      cannula will be inserted under local anesthesia to monitor blood pressure. A premedication&#xD;
      with midazolam (0.05-0.1 mg / kg) will be administered before anesthesia is performed.&#xD;
&#xD;
      At this point, the type of anesthesia will be followed on the basis of the randomization&#xD;
      group.&#xD;
&#xD;
      The following variables will be evaluated:&#xD;
&#xD;
        -  hemodynamic parameters in the perioperative period&#xD;
&#xD;
        -  onset time of the sensory and motor block&#xD;
&#xD;
        -  fluids and vasoactive drugs administered&#xD;
&#xD;
        -  anesthesiological complications&#xD;
&#xD;
        -  degree of patient satisfaction&#xD;
&#xD;
        -  duration of surgery&#xD;
&#xD;
        -  degree of postoperative pain and analgesic therapy administered&#xD;
&#xD;
        -  mini mental state evaluation (in the preoperative and postoperative period)&#xD;
&#xD;
        -  start physical rehabilitation&#xD;
&#xD;
        -  clinical complications during hospitalization&#xD;
&#xD;
        -  duration of hospitalization&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the systolic blood pressure</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>Systolic blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of the diastolic blood pressure</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>Diastolic blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of the mean blood pressure</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>Mean blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of the heart rate</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>Heart rate will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the onset time of the nerve block</measure>
    <time_frame>Up to 20 minutes</time_frame>
    <description>Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the degree of the sensory block</measure>
    <time_frame>Up to 20 minutes after the end of the anesthetic procedure</time_frame>
    <description>Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the Motor block degree</measure>
    <time_frame>Up to 20 minutes after the end of the anesthetic procedure</time_frame>
    <description>The motor block will be assessed by the Bromage scale after the end of the anesthetic procedure. Grade 1: complete block (unable to move feet or knees). Grade 2: almost complete block (able to move feet only). Grade 3: partial block (just able to move knees). Grade 4: detectable weakness of hip flexion (between score 3 and 5). Grade 5: No detectable weakness of hip flexion while supine (full flexion of knees). Grade 6: able to perform partial knee bend.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount ephedrine administered during the perioperative period</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>Ephedrine use, mg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount atrophine administered during the perioperative period</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>Atropine use, mg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount Fluids administered during the perioperative period</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>All fluids administered, ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Degree of patient satisfaction</measure>
    <time_frame>At the end of surgery</time_frame>
    <description>the degree of patient satisfaction will be measured on a scale ranging from 0 to 3 (0= bad; 1= not bad; 2=good; 3=excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of surgery</measure>
    <time_frame>During surgery</time_frame>
    <description>minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain score</measure>
    <time_frame>1, 3, 6, 12, 24, 36, 48 hours after the end of surgery</time_frame>
    <description>11-point numeric rating scale ranging from '0' representing one extreme (e.g. &quot;extremely dissatisfied&quot;) to '10' representing the other extreme (e.g. &quot;extremely satisfied&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of analgesic drugs administered</measure>
    <time_frame>1, 3, 6, 12, 24, 36, 48 hours after the end of surgery</time_frame>
    <description>Paracetamol use, mg; Morphine use, mg; Ketorolac use, mg.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of mental state</measure>
    <time_frame>Preoperative; 24 hours after the end of surgery; 48 h after the end of surgery, 72 h after the end of surgery and 96 h after the end of surgery.</time_frame>
    <description>It will be evaluated through the mini mental state evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beginning of physical rehabilitation</measure>
    <time_frame>Immediately after the surgery</time_frame>
    <description>number of day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anesthetic and surgery complications</measure>
    <time_frame>During anesthetic and surgery procedures</time_frame>
    <description>Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, local anesthetic epidural spread, local anesthetic systemic toxicity, nausea and vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical complications</measure>
    <time_frame>Immediately after the surgery</time_frame>
    <description>Assessment for existence of complications related to procedures in form of Y/N (such as neuropathy, nausea and vomiting, heart and vascular diseases, respiratory dysfunction, urinary retention, renal failure, cognitive disorder, death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>Up to one month</time_frame>
    <description>Duration (day) of hospital stay</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Peripheral nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant will receive a combination of lumbar plexus block, sciatic nerve block, lateral femoral cutaneous nerve block and lateral branch of iliohypogastric nerve block</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Spinal anesthesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participant will receive a combination of spinal anesthesia and lumbar plexus block</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Peripheral nerve block</intervention_name>
    <description>In this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during hip surgery.&#xD;
Lumbar plexus and sciatic nerve blocks will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle and plantar or dorsal flexion of the foot will be detected respectively. For both, a mixture of mepivacaine and levobupivacaine will be injected.&#xD;
Lateral femoral cutaneous nerve block will be performed with the ultrasound technique. After identifying the nerve, a needle will be inserted with an &quot;in plane&quot; approach and will be injected.&#xD;
Lateral branch of iliohypogastric nerve block will be executed with the &quot;De Visme approach&quot;. Along the iliac crest (range between 7 and 11 cm from the anterior superior iliac spine) a needle will be inserted until bone contact is found. Then a mixture of mepivacaine and levobupivacaine will be injected.</description>
    <arm_group_label>Peripheral nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal anesthesia</intervention_name>
    <description>In this group, spinal anesthesia will be performed to ensure anesthesia during surgery, while lumbar plexus block will be performed to ensure postoperative analgesia Spinal anesthesia will be performed with a 25 G needle and 12 mg 0.5% levobupivacaine will be injected.&#xD;
Lumbar plexus block will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle will be detected. 20 ml 0.5% levobupivacaine will be injected.</description>
    <arm_group_label>Spinal anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject has signed and dated an Informed Consent Form&#xD;
&#xD;
          -  Subject is classified as a ASA (American Society of Anesthesiologists) status I-IV&#xD;
&#xD;
          -  Subject is age 18- 99 years old&#xD;
&#xD;
          -  Patients undergoing total hip arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject inability to provide adequate informed consent&#xD;
&#xD;
          -  Study refusal&#xD;
&#xD;
          -  Age younger than 18 years&#xD;
&#xD;
          -  Contraindication to regional anesthesia&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Neurological disease of the lower limbs&#xD;
&#xD;
          -  Moderate or severe dementia disease&#xD;
&#xD;
          -  Psychiatric disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diego Tavoletti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedali riuniti di Ancona-Università politecnica delle Marche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ospedali Riuniti di Ancona - Università politecnica delle marche</name>
      <address>
        <city>Ancona</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università Politecnica delle Marche</investigator_affiliation>
    <investigator_full_name>Diego Tavoletti</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Regional anesthesia</keyword>
  <keyword>Hip arthroplasty</keyword>
  <keyword>Nerve block</keyword>
  <keyword>Lumbar plexus block</keyword>
  <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/NCT04506450
org study id: 721
nct id: NCT04506450
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anesthesia plays an important role in the patient's outcome: each anesthesiological technique
      has a different cardiovascular impact, because they act differently on the autonomic nervous
      system, which in turn regulates heart rate, myocardial contractility and vascular tone.

      Subarachnoid anesthesia can result in a reduction in cardiac output, hypotension and
      bradycardia due to blockage of the nerve fibers of the sympathetic system, while peripheral
      nerve block is associated with a lower impact on the autonomic nervous system, therefore less
      influence on hemodynamic changes compared to subarachnoid anesthesia.

      Hypotension can lead to myocardial ischaemia, especially in patients at high surgical risk.

      In addition, peripheral nerve block allows for better coverage from postoperative pain
      compared to subarachnoid anesthesia in patients undergoing hip surgery.

      This leads to less postoperative stress, with less impact on cardiac and respiratory
      function.

      Numerous studies have shown the efficacy and safety of regional anesthesia in hip surgery.

      This study aims to compare the hemodynamic changes of subarachnoid anesthesia and peripheral
      nerve block in patients who underwent total and partial hip replacement
All patients who meet the inclusion and exclusion criteria will be enrolled. Enrolled
      patients will be informed of the study modality. In case of a favorable opinion, the patient
      will be made to sign the informed consent. Subsequently a code will be assigned to the
      patient for randomization.

      There are two randomization groups: in the PNB group the patient will undergo lumbar plexus
      block, sciatic nerve block, lateral femoral cutaneous nerve block and lateral branch of
      iliohypogastric nerve block, while in the SA group, the patient will undergo subarachnoid
      anesthesia and lumbar plexus block.

      In the preoperative room, ECG, pulseoximetry will be estabilished and an arterial radial
      cannula will be inserted under local anesthesia to monitor blood pressure. A premedication
      with midazolam (0.05-0.1 mg / kg) will be administered before anesthesia is performed.

      At this point, the type of anesthesia will be followed on the basis of the randomization
      group.

      The following variables will be evaluated:

        -  hemodynamic parameters in the perioperative period

        -  onset time of the sensory and motor block

        -  fluids and vasoactive drugs administered

        -  anesthesiological complications

        -  degree of patient satisfaction

        -  duration of surgery

        -  degree of postoperative pain and analgesic therapy administered

        -  mini mental state evaluation (in the preoperative and postoperative period)

        -  start physical rehabilitation

        -  clinical complications during hospitalization

        -  duration of hospitalization
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: Change of the systolic blood pressure
time frame: During anesthetic and surgery procedures
description: Systolic blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
measure: Change of the diastolic blood pressure
time frame: During anesthetic and surgery procedures
description: Diastolic blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
measure: Change of the mean blood pressure
time frame: During anesthetic and surgery procedures
description: Mean blood pressure will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
measure: Change of the heart rate
time frame: During anesthetic and surgery procedures
description: Heart rate will be evalueted after sedation, at the end of the anesthestic procedure, and then every 2.5 minutes up to the 20th minute. Then at the beginning of the surgery and every 5 minutes until the end of the surgery
measure: Change in the onset time of the nerve block
time frame: Up to 20 minutes
description: Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure
measure: Change in the degree of the sensory block
time frame: Up to 20 minutes after the end of the anesthetic procedure
description: Sensitivity to the lower limbs will be assessed by pinprick test and cold test after the end of the anesthetic procedure
measure: Change of the Motor block degree
time frame: Up to 20 minutes after the end of the anesthetic procedure
description: The motor block will be assessed by the Bromage scale after the end of the anesthetic procedure. Grade 1: complete block (unable to move feet or knees). Grade 2: almost complete block (able to move feet only). Grade 3: partial block (just able to move knees). Grade 4: detectable weakness of hip flexion (between score 3 and 5). Grade 5: No detectable weakness of hip flexion while supine (full flexion of knees). Grade 6: able to perform partial knee bend.
measure: Amount ephedrine administered during the perioperative period
time frame: During anesthetic and surgery procedures
description: Ephedrine use, mg.
measure: Amount atrophine administered during the perioperative period
time frame: During anesthetic and surgery procedures
description: Atropine use, mg.
measure: Amount Fluids administered during the perioperative period
time frame: During anesthetic and surgery procedures
description: All fluids administered, ml.
measure: Degree of patient satisfaction
time frame: At the end of surgery
description: the degree of patient satisfaction will be measured on a scale ranging from 0 to 3 (0= bad; 1= not bad; 2=good; 3=excellent)
measure: Duration of surgery
time frame: During surgery
description: minutes
measure: Postoperative pain score
time frame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
description: 11-point numeric rating scale ranging from '0' representing one extreme (e.g. "extremely dissatisfied") to '10' representing the other extreme (e.g. "extremely satisfied")
measure: Amount of analgesic drugs administered
time frame: 1, 3, 6, 12, 24, 36, 48 hours after the end of surgery
description: Paracetamol use, mg; Morphine use, mg; Ketorolac use, mg.
measure: Assessment of mental state
time frame: Preoperative; 24 hours after the end of surgery; 48 h after the end of surgery, 72 h after the end of surgery and 96 h after the end of surgery.
description: It will be evaluated through the mini mental state evaluation
measure: Beginning of physical rehabilitation
time frame: Immediately after the surgery
description: number of day
measure: Anesthetic and surgery complications
time frame: During anesthetic and surgery procedures
description: Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, local anesthetic epidural spread, local anesthetic systemic toxicity, nausea and vomiting
measure: Clinical complications
time frame: Immediately after the surgery
description: Assessment for existence of complications related to procedures in form of Y/N (such as neuropathy, nausea and vomiting, heart and vascular diseases, respiratory dysfunction, urinary retention, renal failure, cognitive disorder, death
measure: Duration of hospitalization
time frame: Up to one month
description: Duration (day) of hospital stay
arm group label: Peripheral nerve block
arm group type: Active Comparator
description: The participant will receive a combination of lumbar plexus block, sciatic nerve block, lateral femoral cutaneous nerve block and lateral branch of iliohypogastric nerve block
arm group label: Spinal anesthesia
arm group type: Active Comparator
description: The participant will receive a combination of spinal anesthesia and lumbar plexus block
intervention type: Procedure
intervention name: Peripheral nerve block
description: In this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during hip surgery.
Lumbar plexus and sciatic nerve blocks will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle and plantar or dorsal flexion of the foot will be detected respectively. For both, a mixture of mepivacaine and levobupivacaine will be injected.
Lateral femoral cutaneous nerve block will be performed with the ultrasound technique. After identifying the nerve, a needle will be inserted with an "in plane" approach and will be injected.
Lateral branch of iliohypogastric nerve block will be executed with the "De Visme approach". Along the iliac crest (range between 7 and 11 cm from the anterior superior iliac spine) a needle will be inserted until bone contact is found. Then a mixture of mepivacaine and levobupivacaine will be injected.
arm group label: Peripheral nerve block
intervention type: Procedure
intervention name: Spinal anesthesia
description: In this group, spinal anesthesia will be performed to ensure anesthesia during surgery, while lumbar plexus block will be performed to ensure postoperative analgesia Spinal anesthesia will be performed with a 25 G needle and 12 mg 0.5% levobupivacaine will be injected.
Lumbar plexus block will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle will be detected. 20 ml 0.5% levobupivacaine will be injected.
arm group label: Spinal anesthesia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Diego Tavoletti, MD
role: Principal Investigator
affiliation: Ospedali riuniti di Ancona-Università politecnica delle Marche
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università Politecnica delle Marche
investigator full name: Diego Tavoletti
investigator title: Principal Investigator
mesh term: Anesthetics