<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/NCT02198547</url>
  </required_header>
  <id_info>
    <org_study_id>CarGalMg</org_study_id>
    <nct_id>NCT02198547</nct_id>
  </id_info>
  <brief_title>Magnesium as Adjuvant for Sciatic Block</brief_title>
  <acronym>Mg</acronym>
  <official_title>Evaluation of Magnesium as Adjuvant to Ropivacaine for Sciatic Block at Popliteal Level.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Campus Bio-Medico University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Campus Bio-Medico University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time&#xD;
      and can enhance offset time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are randomly divided into two groups: group &quot;M&quot; (Ropivacaina 7,5 mg/ml with Mg 4&#xD;
      mg/Kg)and group&quot;C&quot; (without Mg).&#xD;
&#xD;
      Standard monitoring is applied to each patient in perioperative period. An indipendent&#xD;
      observer collect data: time to perform block, sensitivity onset,motor onset, pain during&#xD;
      surgery and complication.&#xD;
&#xD;
      In the post-operative period till 24 hours for each patient is evaluated off-set time, pain&#xD;
      and analgesic consumption.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">September 2022</completion_date>
  <primary_completion_date type="Actual">July 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Mg as adjuvant to local anesthetic</measure>
    <time_frame>Till 24 hours</time_frame>
    <description>We evaluate if Mg affects onset and offset time of ropivacaine 7,5 mg/ml in sciatic block at popliteal level</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>3 hours</time_frame>
    <description>We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative analgesic consumption</measure>
    <time_frame>till 24 hours</time_frame>
    <description>We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>6 hours</time_frame>
    <description>Evaluation of pain with NRS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>post-operative pain</measure>
    <time_frame>12 hours</time_frame>
    <description>Evaluation of pain with NRS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative pain</measure>
    <time_frame>24 hours</time_frame>
    <description>Evaluation of pain with NRS scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patients' approval</measure>
    <time_frame>At 24 hours</time_frame>
    <description>We evaluate the grade of approval of patients with a questionnaire</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hallux Valgus</condition>
  <arm_group>
    <arm_group_label>Ropivacaine Magnesium sulfate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg.&#xD;
Sciatic block at popliteal level.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>Mg used with ropivacaine for sciatic nerve blick</description>
    <arm_group_label>Ropivacaine Magnesium sulfate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Ropivacaine 7,5 mg/ml used for sciatic nerve block</description>
    <arm_group_label>Ropivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  given consent&#xD;
&#xD;
          -  allux valgus correction surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to local anesthetic&#xD;
&#xD;
          -  infection in the site of puncture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimiliano Carassiti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Campus Bio Medico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Campus Bio-Medico</name>
      <address>
        <city>Rome</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.</citation>
    <PMID>22012543</PMID>
  </reference>
  <reference>
    <citation>Ekmekci P, Bengisun ZK, Akan B, Kazbek BK, Ozkan KS, Suer AH. The effect of magnesium added to levobupivacaine for femoral nerve block on postoperative analgesia in patients undergoing ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1119-24. doi: 10.1007/s00167-012-2093-4. Epub 2012 Jun 14.</citation>
    <PMID>22696144</PMID>
  </reference>
  <reference>
    <citation>Dogru K, Yildirim D, Ulgey A, Aksu R, Bicer C, Boyaci A. Adding magnesium to levobupivacaine for axillary brachial plexus block in arteriovenous fistule surgery. Bratisl Lek Listy. 2012;113(10):607-9. doi: 10.4149/bll_2012_136.</citation>
    <PMID>23094900</PMID>
  </reference>
  <reference>
    <citation>Vastani N, Seifert B, Spahn DR, Maurer K. Sensitivities of rat primary sensory afferent nerves to magnesium: implications for differential nerve blocks. Eur J Anaesthesiol. 2013 Jan;30(1):21-8. doi: 10.1097/EJA.0b013e32835949ab.</citation>
    <PMID>23138572</PMID>
  </reference>
  <reference>
    <citation>Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.</citation>
    <PMID>24534592</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>March 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>January 28, 2021</last_update_submitted>
  <last_update_submitted_qc>January 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Campus Bio-Medico University</investigator_affiliation>
    <investigator_full_name>Massimiliano Carassiti</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Local anesthetic adjuvant,</keyword>
  <keyword>Magnesium solfatus,</keyword>
  <keyword>Sciatic block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium Sulfate</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/NCT02198547
org study id: CarGalMg
nct id: NCT02198547
lead sponsor: 
has dmc: No
The aim of the study is to evaluate if Magnesium added to ropivacaine can reduce onset time
      and can enhance offset time.
Patients are randomly divided into two groups: group "M" (Ropivacaina 7,5 mg/ml with Mg 4
      mg/Kg)and group"C" (without Mg).

      Standard monitoring is applied to each patient in perioperative period. An indipendent
      observer collect data: time to perform block, sensitivity onset,motor onset, pain during
      surgery and complication.

      In the post-operative period till 24 hours for each patient is evaluated off-set time, pain
      and analgesic consumption.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Evaluation of Mg as adjuvant to local anesthetic
time frame: Till 24 hours
description: We evaluate if Mg affects onset and offset time of ropivacaine 7,5 mg/ml in sciatic block at popliteal level
measure: Post-operative pain
time frame: 3 hours
description: We evaluate post-operative pain at rest and in movement at 3-6-12-24 hours with NRS scale
measure: Post-operative analgesic consumption
time frame: till 24 hours
description: We evaluate consumption of opioid and non-opioid analgesic used in the post-operative period.
measure: Post-operative pain
time frame: 6 hours
description: Evaluation of pain with NRS scale
measure: post-operative pain
time frame: 12 hours
description: Evaluation of pain with NRS scale
measure: Post-operative pain
time frame: 24 hours
description: Evaluation of pain with NRS scale
measure: Patients' approval
time frame: At 24 hours
description: We evaluate the grade of approval of patients with a questionnaire
arm group label: Ropivacaine Magnesium sulfate
arm group type: Experimental
description: Locoregional anesthesia for valgus allux correction with ropivacaine 7,5 mg/ml and Mg 4 mg/Kg.
Sciatic block at popliteal level.
arm group label: Ropivacaine
arm group type: Active Comparator
description: Patients undergoing allux valgus correction with locoregional anesthesia with ropivacaine 7,5 mg/ml, without MG
intervention type: Drug
intervention name: Magnesium Sulfate
description: Mg used with ropivacaine for sciatic nerve blick
arm group label: Ropivacaine Magnesium sulfate
intervention type: Drug
intervention name: Ropivacaine
description: Ropivacaine 7,5 mg/ml used for sciatic nerve block
arm group label: Ropivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Massimiliano Carassiti, MD
role: Principal Investigator
affiliation: Campus Bio Medico
facility: 
country: Italy
citation: Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.
PMID: 22012543
citation: Ekmekci P, Bengisun ZK, Akan B, Kazbek BK, Ozkan KS, Suer AH. The effect of magnesium added to levobupivacaine for femoral nerve block on postoperative analgesia in patients undergoing ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2013 May;21(5):1119-24. doi: 10.1007/s00167-012-2093-4. Epub 2012 Jun 14.
PMID: 22696144
citation: Dogru K, Yildirim D, Ulgey A, Aksu R, Bicer C, Boyaci A. Adding magnesium to levobupivacaine for axillary brachial plexus block in arteriovenous fistule surgery. Bratisl Lek Listy. 2012;113(10):607-9. doi: 10.4149/bll_2012_136.
PMID: 23094900
citation: Vastani N, Seifert B, Spahn DR, Maurer K. Sensitivities of rat primary sensory afferent nerves to magnesium: implications for differential nerve blocks. Eur J Anaesthesiol. 2013 Jan;30(1):21-8. doi: 10.1097/EJA.0b013e32835949ab.
PMID: 23138572
citation: Bailard NS, Ortiz J, Flores RA. Additives to local anesthetics for peripheral nerve blocks: Evidence, limitations, and recommendations. Am J Health Syst Pharm. 2014 Mar 1;71(5):373-85. doi: 10.2146/ajhp130336.
PMID: 24534592
responsible party type: Principal Investigator
investigator affiliation: Campus Bio-Medico University
investigator full name: Massimiliano Carassiti
investigator title: MD
mesh term: Hallux Valgus
mesh term: Magnesium Sulfate
mesh term: Ropivacaine