<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/NCT02185859</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0375</org_study_id>
    <nct_id>NCT02185859</nct_id>
  </id_info>
  <brief_title>Effect of Perioperative Intravenous Lidocaine Infusion and Magnesium Infusion on the Functional Recovery After General Anesthesia in the Patients Undergoing Breast Mastectomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Postsurgical pain is a relevant side effect following surgery which increases the risk of&#xD;
      various complications and delays postoperative patient recovery. Among the many types of&#xD;
      surgeries, mastectomy causes not only acute but also chronic pain in many patients.&#xD;
      Therefore, it is important to control pain and increase patients' recovery satisfaction&#xD;
      following many kinds of operations by using as small an opioid analgesic dose as possible and&#xD;
      adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among&#xD;
      nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be&#xD;
      helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical&#xD;
      stimuli. An intraoperative intravenous injection of lidocaine has been reported to improve&#xD;
      postoperative pain control by reducing postoperative pain and opioid consumption. Another&#xD;
      report showed that an intraoperative intravenous injection of lidocaine improved the quality&#xD;
      of postoperative functional recovery after general anesthesia in a laparoscopic&#xD;
      cholecystectomy patient. In addition, a review article on the effect of intraoperative&#xD;
      intravenous injection of magnesium found it to be an effective analgesic that may be added to&#xD;
      conventional opioid-based therapy because it generally reduces opioid consumption, decreases&#xD;
      pain assessment for 24 hours after surgery, and lacks severe side effects in relation to&#xD;
      magnesium administration. However, there has been insufficient research comparing the&#xD;
      intraoperative intravenous injection of lidocaine or magnesium in terms of which is more&#xD;
      helpful for general functional recovery and decreased postoperative pain. Recently, the scope&#xD;
      of research on anesthesia has come to embrace postanesthetic recovery; to help patients&#xD;
      return to daily life, the research trend is now shifting from the improvement or resolution&#xD;
      of a specific symptom to the measurement of general recovery. A widely used method to measure&#xD;
      postoperative recovery is the Quality of Recovery 40 (QoR-40) survey.&#xD;
&#xD;
      Therefore, in this study, the researchers investigated the intraoperative intravenous&#xD;
      injection of lidocaine and the intravenous injection of magnesium to compare these drugs'&#xD;
      helpfulness in the functional recovery of mastectomy patients after general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of QoR-40 global scores</measure>
    <time_frame>24 hours after mastectomy</time_frame>
    <description>The investigators will evaluate the quality of recovery after general anesthesia by considering the global score (200 points in total) of QoR-40 surveys, which is obtained by summing the subtotal scores for emotional status, physical comfort, psychological support, physical independence, and pain. The QoR-40 administered 24 hours after the operation is the primary endpoint of this research.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Perioperative lidocaine infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Perioperative magnesium infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Noraml saline infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>The lidocaine group (Group L)- 1% lidocaine 40 mL is prepared in a 50 mL syringe; A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room. (Group L subjects are administered lidocaine 2 mg/kg for 15 minutes immediately after the anesthesia induction, and then lidocaine 2 mg/kg/h is continuously injected. The dose of lidocaine and magnesium in this study has been shown in previous studies to be safe and to have an analgesic effect.)</description>
    <arm_group_label>Perioperative lidocaine infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Magnesium Sulfate</intervention_name>
    <description>the magnesium group (Group M)- MgSO4 4g 40 mL is prepared in a 50 mL syringe.) A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room. The dose of magnesium in this study has been shown in previous studies to be safe and to have an analgesic effect.</description>
    <arm_group_label>Perioperative magnesium infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>the control group (Group C) - 0.9% normal saline 40 mL is prepared in a 50 cc syringe. A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room.Group C subjects are administered the same dose of normal saline.</description>
    <arm_group_label>Noraml saline infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients aged between 20 and 65 who have undergone mastectomy due to breast cancer and of&#xD;
        American Society of Anesthesiologists (ASA) Physical Status Class 1 or Class 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients experiencing pain for any cause or taking an analgesic&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients with severe heart, kidney, or liver disease&#xD;
&#xD;
          -  Patients with a psychiatric or neurological disorder&#xD;
&#xD;
          -  Patients with a contraindication or allergic response to lidocaine&#xD;
&#xD;
          -  Patients with a contraindication or allergic response to magnesium&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yonsei University, College of Medicine, Yonsei Health System, Yonsei Cancer Center</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>October 16, 2015</last_update_submitted>
  <last_update_submitted_qc>October 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lidocaine</keyword>
  <keyword>Magnesium</keyword>
  <keyword>Mastectomy</keyword>
  <keyword>Functional Recovery</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Magnesium Sulfate</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/NCT02185859
org study id: 4-2014-0375
nct id: NCT02185859
lead sponsor: 
has dmc: No
Postsurgical pain is a relevant side effect following surgery which increases the risk of
      various complications and delays postoperative patient recovery. Among the many types of
      surgeries, mastectomy causes not only acute but also chronic pain in many patients.
      Therefore, it is important to control pain and increase patients' recovery satisfaction
      following many kinds of operations by using as small an opioid analgesic dose as possible and
      adding a nonopioid analgesic to reduce the side effects of narcotic analgesics. Among
      nonopioid analgesics, lidocaine and magnesium are drawing attention, having been shown to be
      helpful in controlling postoperative pain by lowering pain hypersensitivity to surgical
      stimuli. An intraoperative intravenous injection of lidocaine has been reported to improve
      postoperative pain control by reducing postoperative pain and opioid consumption. Another
      report showed that an intraoperative intravenous injection of lidocaine improved the quality
      of postoperative functional recovery after general anesthesia in a laparoscopic
      cholecystectomy patient. In addition, a review article on the effect of intraoperative
      intravenous injection of magnesium found it to be an effective analgesic that may be added to
      conventional opioid-based therapy because it generally reduces opioid consumption, decreases
      pain assessment for 24 hours after surgery, and lacks severe side effects in relation to
      magnesium administration. However, there has been insufficient research comparing the
      intraoperative intravenous injection of lidocaine or magnesium in terms of which is more
      helpful for general functional recovery and decreased postoperative pain. Recently, the scope
      of research on anesthesia has come to embrace postanesthetic recovery; to help patients
      return to daily life, the research trend is now shifting from the improvement or resolution
      of a specific symptom to the measurement of general recovery. A widely used method to measure
      postoperative recovery is the Quality of Recovery 40 (QoR-40) survey.

      Therefore, in this study, the researchers investigated the intraoperative intravenous
      injection of lidocaine and the intravenous injection of magnesium to compare these drugs'
      helpfulness in the functional recovery of mastectomy patients after general anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: The difference of QoR-40 global scores
time frame: 24 hours after mastectomy
description: The investigators will evaluate the quality of recovery after general anesthesia by considering the global score (200 points in total) of QoR-40 surveys, which is obtained by summing the subtotal scores for emotional status, physical comfort, psychological support, physical independence, and pain. The QoR-40 administered 24 hours after the operation is the primary endpoint of this research.
arm group label: Perioperative lidocaine infusion
arm group type: Experimental
arm group label: Perioperative magnesium infusion
arm group type: Experimental
arm group label: Noraml saline infusion
arm group type: Active Comparator
intervention type: Drug
intervention name: Lidocaine
description: The lidocaine group (Group L)- 1% lidocaine 40 mL is prepared in a 50 mL syringe; A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room. (Group L subjects are administered lidocaine 2 mg/kg for 15 minutes immediately after the anesthesia induction, and then lidocaine 2 mg/kg/h is continuously injected. The dose of lidocaine and magnesium in this study has been shown in previous studies to be safe and to have an analgesic effect.)
arm group label: Perioperative lidocaine infusion
intervention type: Drug
intervention name: Magnesium Sulfate
description: the magnesium group (Group M)- MgSO4 4g 40 mL is prepared in a 50 mL syringe.) A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room. The dose of magnesium in this study has been shown in previous studies to be safe and to have an analgesic effect.
arm group label: Perioperative magnesium infusion
intervention type: Drug
intervention name: Saline
description: the control group (Group C) - 0.9% normal saline 40 mL is prepared in a 50 cc syringe. A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room.Group C subjects are administered the same dose of normal saline.
arm group label: Noraml saline infusion
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Lidocaine
mesh term: Magnesium Sulfate