<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/NCT01734954</url>
  </required_header>
  <id_info>
    <org_study_id>IACES</org_study_id>
    <nct_id>NCT01734954</nct_id>
  </id_info>
  <brief_title>Comparison of Two Techniques of Sciatic Nerve Block With Levobupivacaine 0.5% in Orthopedic Surgery</brief_title>
  <official_title>Comparison of Two Techniques of Ultrasound-guided Sciatic Nerve Block Using Levobupivacaine 0.5% in Orthopedic Surgery at the Hospital Pablo Tobon Uribe - Clínica CES, 2013, Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CES University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Pablo Tobón Uribe</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clínica CES</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CES University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the latency period (timing between the injection of&#xD;
      the local anesthetic and the onset of complete sensory nerve block) of two approaches for&#xD;
      ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of&#xD;
      the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is&#xD;
      injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned&#xD;
      nerve. Our main hypothesis is that the first approach will decrease the latency period, and&#xD;
      probably, will increase the success rate of the nerve block as well as patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve&#xD;
      versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is&#xD;
      the latency period of the nerve blockade; the secondary outcomes are rate of success of the&#xD;
      procedure as well as patient satisfaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">August 2013</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Latency period of sciatic nerve block.</measure>
    <time_frame>5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.</time_frame>
    <description>Once the nerve blockade is done, a sensory evaluation will be performed in the surgical area every five minutes to determine the onset of the sensory nerve blockade in minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success of sciatic nerve block</measure>
    <time_frame>Every 5 minutes until 30 minutes until the end of the procedure for the nerve block; an additional measure will be performed at the end of of the surgery.</time_frame>
    <description>The time to achieve a complete sensory nerve block, reached maximum at 30 minutes, in full distribution of tibial nerve and common fibular nerve for anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Postoperative 24 hours</time_frame>
    <description>Using a categorical score we will measure satisfaction of nerve-block-procedure satisfaction and analgesia quality one day after surgery: patients will choose one of three options: no satisfied, satisfied or very satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory block</measure>
    <time_frame>5, 10, 15, 20, 25 and 30 minutes after the block is finished</time_frame>
    <description>Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves&#xD;
0: Complete sensory block&#xD;
Almost complete sensory block: Decreased sensation to pinprick with a 24 gauge hypodermic needle&#xD;
Feeling normal (for each component: tibial and common peroneal) compared with the contralateral leg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor block</measure>
    <time_frame>5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished</time_frame>
    <description>Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves 0: Complete motor blockade&#xD;
Motor block almost complete&#xD;
No motor block (for the tibial component for plantarflexion and dorsiflexion with the common peroneal) compared with the contralateral leg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First analgesic</measure>
    <time_frame>5 minutes, 30 minutes, 24 hours postoperative</time_frame>
    <description>Time of first analgesic requirement in postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual analog scale at rest</measure>
    <time_frame>5 minutes, 30 minutes, 24 hours postoperative</time_frame>
    <description>Pain rating ranging from zero to ten VAS 0: no pain VAS 1-3: Mild pain VAS 4-6: Moderate Pain VAS 7-10: Severe pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic visual analog scale</measure>
    <time_frame>5 minutes, 30 minutes, 24 hours postoperative</time_frame>
    <description>Pain rating ranging from zero to ten with the movement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraneural injection</measure>
    <time_frame>At the time of injection and execution of the block</time_frame>
    <description>Increased diameter nerve or visualized by ultrasound visualization of the needle into the nerve at the time of injection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vascular puncture</measure>
    <time_frame>During the execution of the block</time_frame>
    <description>Puncture of one or more blood vessels to visualize the needle within the vessel or to aspirate blood during block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paresthesia during the procedure</measure>
    <time_frame>At the time of the execution of the block</time_frame>
    <description>Paresthesia during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic toxicity of local anesthetics</measure>
    <time_frame>During the execution of the block and 30 minutes after it</time_frame>
    <description>Systemic toxicity of local anesthetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematoma</measure>
    <time_frame>During and inmmediately after the execution of the block</time_frame>
    <description>Hematoma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle weakness</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>Subjective reduction in muscle strength at 24 hours postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Altered sensitivity</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>Subjective decreased sensitivity at 24 hours postoperative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cramps postoperative</measure>
    <time_frame>24 hours postoperative of the block</time_frame>
    <description>Feeling cramps within 24 hours of the block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Punctures</measure>
    <time_frame>During the block</time_frame>
    <description>Number of skin punctures during the block</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for the execution of nerve block</measure>
    <time_frame>In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle</time_frame>
    <description>Time from placement of the transducer for the initial scan to final withdrawal of the needle</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided block at the bifurcation of the sciatic nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sciatic nerve anesthesia blockade at bifurcation.</intervention_name>
    <description>A proximal and distal initial scan and define the site to block the bifurcation. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% and a total volume of 20 mL.</description>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
    <other_name>Sciatic Nerve Block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sciatic nerve blockade 2 cm beyond the bifurcation</intervention_name>
    <description>A proximal and distal initial scan and define the sites to block: tibial and peroneal nerves separate distal 2 cm from the bifurcation site. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% 10 mL tibial nerve and 10 mL to the peroneal nerve.</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <other_name>Sciatic nerve block</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levobupivacaine 0.5%: 20 ml</intervention_name>
    <description>Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
    <other_name>Local Anesthetic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA</intervention_name>
    <description>An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
    <other_name>Ultrasound</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)</intervention_name>
    <description>This is a specific kind of needle that is widely used for anesthesia nerve blockade.</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
    <other_name>Nerve blockade needle short bevel.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>supplemental oxygen</intervention_name>
    <description>supplemental oxygen during the block and/or during surgery</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
    <other_name>oxygen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midazolam</intervention_name>
    <description>Intravenous midazolam for sedation during the block and/or during surgery</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous analgesics</intervention_name>
    <description>Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Saphenous nerve block</intervention_name>
    <description>Depending on sensitive territory committed by the type of surgery suprapatellar saphenous nerve block guided by ultrasound with 100 mm Stimuplex needle and injection of levobupivacaine 0.5% (total volume: 5 ml).</description>
    <arm_group_label>Sciatic block 2 cm beyond bifurcation</arm_group_label>
    <arm_group_label>Sciatic nerve blockade at bifurcation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for ankle or foot surgery at Hospital Pablo Tobón Uribe and Clínica&#xD;
             CES.&#xD;
&#xD;
          -  Physical status classification of the American Society of Anesthesiologists (ASA) 1-3.&#xD;
&#xD;
          -  Age: 18-70 years.&#xD;
&#xD;
          -  Weight: 40-100 kg&#xD;
&#xD;
          -  Taller than 140 cm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No patient acceptance.&#xD;
&#xD;
          -  Contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis,&#xD;
             infection at the site of puncture).&#xD;
&#xD;
          -  Neuropathy or myopathy affecting the lower limb.&#xD;
&#xD;
          -  Psychiatric or neurological diseases that alter the evaluation of patient.&#xD;
&#xD;
          -  Arrhythmias.&#xD;
&#xD;
          -  Heart failure.&#xD;
&#xD;
          -  Diabetes Mellitus.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Language barriers.&#xD;
&#xD;
          -  Anticoagulation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marta I Berrio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CES University, Medellín, Antioquia, Colombia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marta I Berrio, MD</last_name>
    <phone>+57 301 4839308</phone>
    <email>martaberrio@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juan-Felipe Vargas, MD</last_name>
    <phone>+57 311 6306919</phone>
    <email>vargasj@une.net.co</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Pablo Tobón Uribe</name>
      <address>
        <city>Medellín</city>
        <state>Antioquia</state>
        <zip>050034</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <contact>
      <last_name>Marta I Berrio, MD</last_name>
      <phone>+57 3014839308</phone>
      <email>martaberrio@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Marta I Berrio, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Juan-Felipe Vargas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clínica CES</name>
      <address>
        <city>Medellín</city>
        <state>Antioquia</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>November 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>April 17, 2013</last_update_submitted>
  <last_update_submitted_qc>April 17, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 19, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CES University</investigator_affiliation>
    <investigator_full_name>Marta Inés Berrío Valencia</investigator_full_name>
    <investigator_title>Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Nerve block</keyword>
  <keyword>Sciatic nerve</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Orthopedics</keyword>
  <keyword>Hallux Valgus</keyword>
  <keyword>Amputation</keyword>
  <keyword>Arthrodesis</keyword>
  <keyword>Arthroscopy</keyword>
  <keyword>Fracture fixation</keyword>
  <keyword>Osteotomy</keyword>
  <keyword>Tendon transfer</keyword>
  <keyword>Tenodesis</keyword>
  <keyword>Tenotomy</keyword>
  <keyword>Orthopedic procedure</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Analgesics</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Levobupivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</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/NCT01734954
org study id: IACES
nct id: NCT01734954
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the latency period (timing between the injection of
      the local anesthetic and the onset of complete sensory nerve block) of two approaches for
      ultrasound-guided popliteal sciatic nerve block: One of the approaches is the injection of
      the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is
      injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned
      nerve. Our main hypothesis is that the first approach will decrease the latency period, and
      probably, will increase the success rate of the nerve block as well as patient satisfaction.
Compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve
      versus distal (tibial and peroneal) using only levobupivacaine 0.5%. The primary outcome is
      the latency period of the nerve blockade; the secondary outcomes are rate of success of the
      procedure as well as patient satisfaction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Latency period of sciatic nerve block.
time frame: 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes and 30 minutes after nerve block.
description: Once the nerve blockade is done, a sensory evaluation will be performed in the surgical area every five minutes to determine the onset of the sensory nerve blockade in minutes.
measure: Success of sciatic nerve block
time frame: Every 5 minutes until 30 minutes until the end of the procedure for the nerve block; an additional measure will be performed at the end of of the surgery.
description: The time to achieve a complete sensory nerve block, reached maximum at 30 minutes, in full distribution of tibial nerve and common fibular nerve for anesthesia.
measure: Patient satisfaction
time frame: Postoperative 24 hours
description: Using a categorical score we will measure satisfaction of nerve-block-procedure satisfaction and analgesia quality one day after surgery: patients will choose one of three options: no satisfied, satisfied or very satisfied.
measure: Sensory block
time frame: 5, 10, 15, 20, 25 and 30 minutes after the block is finished
description: Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves
0: Complete sensory block
Almost complete sensory block: Decreased sensation to pinprick with a 24 gauge hypodermic needle
Feeling normal (for each component: tibial and common peroneal) compared with the contralateral leg
measure: Motor block
time frame: 5, 10, 15, 20, 25 and 30 minutes of completion after the block is finished
description: Evaluation in 5, 10, 15, 20, 25 and 30 minutes after the procedure in the distribution of the common peroneal and tibial nerves 0: Complete motor blockade
Motor block almost complete
No motor block (for the tibial component for plantarflexion and dorsiflexion with the common peroneal) compared with the contralateral leg
measure: First analgesic
time frame: 5 minutes, 30 minutes, 24 hours postoperative
description: Time of first analgesic requirement in postoperative
measure: Visual analog scale at rest
time frame: 5 minutes, 30 minutes, 24 hours postoperative
description: Pain rating ranging from zero to ten VAS 0: no pain VAS 1-3: Mild pain VAS 4-6: Moderate Pain VAS 7-10: Severe pain
measure: Dynamic visual analog scale
time frame: 5 minutes, 30 minutes, 24 hours postoperative
description: Pain rating ranging from zero to ten with the movement
measure: Intraneural injection
time frame: At the time of injection and execution of the block
description: Increased diameter nerve or visualized by ultrasound visualization of the needle into the nerve at the time of injection
measure: Vascular puncture
time frame: During the execution of the block
description: Puncture of one or more blood vessels to visualize the needle within the vessel or to aspirate blood during block
measure: Paresthesia during the procedure
time frame: At the time of the execution of the block
description: Paresthesia during the procedure
measure: Systemic toxicity of local anesthetics
time frame: During the execution of the block and 30 minutes after it
description: Systemic toxicity of local anesthetics
measure: Hematoma
time frame: During and inmmediately after the execution of the block
description: Hematoma
measure: Muscle weakness
time frame: 24 hours postoperative
description: Subjective reduction in muscle strength at 24 hours postoperative
measure: Altered sensitivity
time frame: 24 hours postoperative
description: Subjective decreased sensitivity at 24 hours postoperative
measure: Cramps postoperative
time frame: 24 hours postoperative of the block
description: Feeling cramps within 24 hours of the block
measure: Punctures
time frame: During the block
description: Number of skin punctures during the block
measure: Time for the execution of nerve block
time frame: In minutes: Time from placement of the transducer for the initial scan to final withdrawal of the needle
description: Time from placement of the transducer for the initial scan to final withdrawal of the needle
arm group label: Sciatic nerve blockade at bifurcation
arm group type: Experimental
description: Ultrasound-guided block at the bifurcation of the sciatic nerve
arm group label: Sciatic block 2 cm beyond bifurcation
arm group type: Experimental
description: Ultrasound-guided block of the sciatic nerve 2 cm beyond of the bifurcation
intervention type: Procedure
intervention name: Sciatic nerve anesthesia blockade at bifurcation.
description: A proximal and distal initial scan and define the site to block the bifurcation. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% and a total volume of 20 mL.
arm group label: Sciatic nerve blockade at bifurcation
other name: Sciatic Nerve Block
intervention type: Procedure
intervention name: Sciatic nerve blockade 2 cm beyond the bifurcation
description: A proximal and distal initial scan and define the sites to block: tibial and peroneal nerves separate distal 2 cm from the bifurcation site. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% 10 mL tibial nerve and 10 mL to the peroneal nerve.
arm group label: Sciatic block 2 cm beyond bifurcation
other name: Sciatic nerve block
intervention type: Drug
intervention name: Levobupivacaine 0.5%: 20 ml
description: Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
arm group label: Sciatic block 2 cm beyond bifurcation
arm group label: Sciatic nerve blockade at bifurcation
other name: Local Anesthetic
intervention type: Device
intervention name: Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA
description: An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
arm group label: Sciatic block 2 cm beyond bifurcation
arm group label: Sciatic nerve blockade at bifurcation
other name: Ultrasound
intervention type: Device
intervention name: Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)
description: This is a specific kind of needle that is widely used for anesthesia nerve blockade.
arm group label: Sciatic block 2 cm beyond bifurcation
arm group label: Sciatic nerve blockade at bifurcation
other name: Nerve blockade needle short bevel.
intervention type: Drug
intervention name: supplemental oxygen
description: supplemental oxygen during the block and/or during surgery
arm group label: Sciatic block 2 cm beyond bifurcation
arm group label: Sciatic nerve blockade at bifurcation
other name: oxygen
intervention type: Drug
intervention name: Midazolam
description: Intravenous midazolam for sedation during the block and/or during surgery
arm group label: Sciatic block 2 cm beyond bifurcation
arm group label: Sciatic nerve blockade at bifurcation
intervention type: Drug
intervention name: Intravenous analgesics
description: Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg
arm group label: Sciatic block 2 cm beyond bifurcation
arm group label: Sciatic nerve blockade at bifurcation
intervention type: Procedure
intervention name: Saphenous nerve block
description: Depending on sensitive territory committed by the type of surgery suprapatellar saphenous nerve block guided by ultrasound with 100 mm Stimuplex needle and injection of levobupivacaine 0.5% (total volume: 5 ml).
arm group label: Sciatic block 2 cm beyond bifurcation
arm group label: Sciatic nerve blockade at bifurcation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Marta I Berrio, MD
role: Principal Investigator
affiliation: CES University, Medellín, Antioquia, Colombia
last name: Marta I Berrio, MD
phone: +57 301 4839308
email: martaberrio@gmail.com
last name: Juan-Felipe Vargas, MD
phone: +57 311 6306919
email: vargasj@une.net.co
facility: 
contact: 
investigator: 
investigator: 
facility: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: CES University
investigator full name: Marta Inés Berrío Valencia
investigator title: Anesthesiologist
mesh term: Midazolam
mesh term: Analgesics
mesh term: Anesthetics
mesh term: Levobupivacaine
mesh term: Anesthetics, Local