<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/NCT02246517</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-14-SB-0318-CTIL</org_study_id>
    <nct_id>NCT02246517</nct_id>
  </id_info>
  <brief_title>The Effect of N2O on Chronic Neuropathic Pain Patients</brief_title>
  <acronym>N2O</acronym>
  <official_title>The Effect of N2O on Chronic Neuropathic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine&#xD;
      block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also&#xD;
      have antagonist property of NMDA receptors. The investigators hypothesize that prolonged&#xD;
      treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic&#xD;
      neuropathy, post herpetic neuralgia etc.).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine&#xD;
      block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also&#xD;
      have antagonist property of NMDA receptors. The investigators hypothesize that prolonged&#xD;
      treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic&#xD;
      neuropathy, post herpetic neuralgia etc.). In order to examine our theory we Will recruit 40&#xD;
      patients aged 18-65 that suffer from chronic neuropathic pain. The patients will be divided&#xD;
      to two groups of which half will receive treatment with N2O and half with placebo (pure O2)&#xD;
      as a repeated weekly treatment for 4 weeks. At the beginning of the each session the patient&#xD;
      will be asked to fill questionnaires regarding their pain quality and severity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)</measure>
    <time_frame>baseline and average of week for 4 weeks</time_frame>
    <description>Assessment of pain in the last 24 hours before the visit by VAS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)</measure>
    <time_frame>baseline and average of week for 4 weeks</time_frame>
    <description>Assessment of pain in the last 24 hours before the visit by SF-MPQ</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>N2O&amp;Oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>70% N2O &amp; 30% Oxygen by Aspiration for 5 min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxygen</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100% Oxygen by Aspiration for 5 min</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>N2O</intervention_name>
    <arm_group_label>N2O&amp;Oxygen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <arm_group_label>Oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men and women at the age 18-65&#xD;
&#xD;
          -  patient that suffer from chronic neuropathic pain&#xD;
&#xD;
          -  VAS&gt;40&#xD;
&#xD;
          -  DN4 score &gt;4&#xD;
&#xD;
          -  takes pain medication on a regular basis&#xD;
&#xD;
          -  Didn't get epidural injection for the pas month&#xD;
&#xD;
          -  signed an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients that suffer from chronic lung disease.&#xD;
&#xD;
          -  patients with cancer&#xD;
&#xD;
          -  patients with heart disease&#xD;
&#xD;
          -  pregnant and lactate woman&#xD;
&#xD;
          -  patients that suffer from depression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pain Medicine Unit</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Lior Dayan, M.D</last_name>
      <phone>972-50-4051014</phone>
    </contact>
    <investigator>
      <last_name>Silviu Brill, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>September 18, 2014</last_update_submitted>
  <last_update_submitted_qc>September 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tel-Aviv Sourasky Medical Center</investigator_affiliation>
    <investigator_full_name>michal roll</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</mesh_term>
  </condition_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/NCT02246517
org study id: TASMC-14-SB-0318-CTIL
nct id: NCT02246517
lead sponsor: 
has dmc: No
Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine
      block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also
      have antagonist property of NMDA receptors. The investigators hypothesize that prolonged
      treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic
      neuropathy, post herpetic neuralgia etc.).
Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine
      block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also
      have antagonist property of NMDA receptors. The investigators hypothesize that prolonged
      treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic
      neuropathy, post herpetic neuralgia etc.). In order to examine our theory we Will recruit 40
      patients aged 18-65 that suffer from chronic neuropathic pain. The patients will be divided
      to two groups of which half will receive treatment with N2O and half with placebo (pure O2)
      as a repeated weekly treatment for 4 weeks. At the beginning of the each session the patient
      will be asked to fill questionnaires regarding their pain quality and severity
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)
time frame: baseline and average of week for 4 weeks
description: Assessment of pain in the last 24 hours before the visit by VAS
measure: change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)
time frame: baseline and average of week for 4 weeks
description: Assessment of pain in the last 24 hours before the visit by SF-MPQ
arm group label: N2O&Oxygen
arm group type: Experimental
description: 70% N2O & 30% Oxygen by Aspiration for 5 min
arm group label: Oxygen
arm group type: Placebo Comparator
description: 100% Oxygen by Aspiration for 5 min
intervention type: Drug
intervention name: N2O
arm group label: N2O&Oxygen
intervention type: Drug
intervention name: Oxygen
arm group label: Oxygen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Tel-Aviv Sourasky Medical Center
investigator full name: michal roll
investigator title: Dr
mesh term: Neuralgia