<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/NCT03030560</url>
  </required_header>
  <id_info>
    <org_study_id>IRB0000871239</org_study_id>
    <nct_id>NCT03030560</nct_id>
  </id_info>
  <brief_title>Longterm Postoperative Analgesia, Intravenous Lidocaine Infusion</brief_title>
  <acronym>Lidocaine</acronym>
  <official_title>Effect of Intravenous Lidocaine Infusion on Long Term Postoperative Pain After Spinal Fusion Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abdelrady S Ibrahim, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several&#xD;
      studies have indicated that appropriate pain treatment protocols reduce postoperative&#xD;
      morbidity, improve the results of the surgery, and decrease hospital costs&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Forty four patients were randomly allocated into two groups of equal size to receive either&#xD;
      lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).&#xD;
&#xD;
      Randomization: was performed using Lidocaine group and Control group registers, which was&#xD;
      placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a&#xD;
      physician who prepared the intravenous solution and identified it with the patient number,&#xD;
      according to the envelope drawn. The solution was handed to another physician, blind to the&#xD;
      prepared solutions' content, who was responsible for the anesthesia. The solution volume was&#xD;
      equal. The responsible investigator was remained blind to the chosen group until the end of&#xD;
      the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>Phase 2</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 (Care Provider, Investigator)</masking>
    <masking_description>Double Blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>numerical rating scale (NRS), pain score.</measure>
    <time_frame>Postoperative 3 months</time_frame>
    <description>Postoperative numerical rating scale (NRS), pain score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>opioid consumption.</measure>
    <time_frame>Postoperative 24 h</time_frame>
    <description>Postoperative opioid consumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum cortisol.</measure>
    <time_frame>Postoperative 24 h</time_frame>
    <description>Serum cortisol level.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Lidocaine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive lidocaine infusion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will receive 0.9% Sodium-chloride infusion infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.</description>
    <arm_group_label>Lidocaine group</arm_group_label>
    <other_name>Xylocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>0.9% Sodium-chloride</intervention_name>
    <description>patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age &gt; 18 years American Society of Anesthesiologists 1-3 status Patients undergoing spinal&#xD;
        fusion or fixation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous spinal fusion surgery.&#xD;
&#xD;
          2. Morbid obesity (BMI &gt; 40)&#xD;
&#xD;
          3. Diagnosis of spinal metastatic cancer&#xD;
&#xD;
          4. Allergy to an amide local anesthetic or morphine sulfate&#xD;
&#xD;
          5. History of renal dysfunction, liver dysfunction or congestive heart failure&#xD;
&#xD;
          6. History of substance abuse disorder.&#xD;
&#xD;
          7. Chronic opioid use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed G Abdelraheem, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut university faculty of medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Rev Bras Anestesiol. 2010 May-Jun;60(3):325-33. doi: 10.1016/S0034-7094(10)70041-6.</citation>
    <PMID>20682165</PMID>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>November 23, 2017</last_update_submitted>
  <last_update_submitted_qc>November 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Abdelrady S Ibrahim, MD</investigator_full_name>
    <investigator_title>Assistant professor of anesthesia and ICU</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03030560
org study id: IRB0000871239
nct id: NCT03030560
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Spinal fusion is a painful surgery, and control of postoperative pain is difficult. Several
      studies have indicated that appropriate pain treatment protocols reduce postoperative
      morbidity, improve the results of the surgery, and decrease hospital costs
Forty four patients were randomly allocated into two groups of equal size to receive either
      lidocaine infusion (Lidocaine group) or 0.9% sodium chloride infusion (Control group).

      Randomization: was performed using Lidocaine group and Control group registers, which was
      placed in sealed envelopes prior to study initiation and opened prior to anesthesia by a
      physician who prepared the intravenous solution and identified it with the patient number,
      according to the envelope drawn. The solution was handed to another physician, blind to the
      prepared solutions' content, who was responsible for the anesthesia. The solution volume was
      equal. The responsible investigator was remained blind to the chosen group until the end of
      the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
masking description: Double Blind
measure: numerical rating scale (NRS), pain score.
time frame: Postoperative 3 months
description: Postoperative numerical rating scale (NRS), pain score.
measure: opioid consumption.
time frame: Postoperative 24 h
description: Postoperative opioid consumption.
measure: Serum cortisol.
time frame: Postoperative 24 h
description: Serum cortisol level.
arm group label: Lidocaine group
arm group type: Active Comparator
description: Patients will receive lidocaine infusion.
arm group label: Control group
arm group type: Placebo Comparator
description: Patients will receive 0.9% Sodium-chloride infusion infusion
intervention type: Drug
intervention name: Lidocaine
description: patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.
arm group label: Lidocaine group
other name: Xylocaine
intervention type: Drug
intervention name: 0.9% Sodium-chloride
description: patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.
arm group label: Control group
other name: Normal saline
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamed G Abdelraheem, MD
role: Principal Investigator
affiliation: Assiut University
facility: 
country: Egypt
citation: de Oliveira CM, Issy AM, Sakata RK. Intraoperative intravenous lidocaine. Rev Bras Anestesiol. 2010 May-Jun;60(3):325-33. doi: 10.1016/S0034-7094(10)70041-6.
PMID: 20682165
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Abdelrady S Ibrahim, MD
investigator title: Assistant professor of anesthesia and ICU
mesh term: Pain, Postoperative
mesh term: Lidocaine
sharing ipd: No