<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/NCT03238625</url>
  </required_header>
  <id_info>
    <org_study_id>LIDOBICARB</org_study_id>
    <nct_id>NCT03238625</nct_id>
  </id_info>
  <brief_title>Painless Local Anaesthesia With Bicarbonate Admixture</brief_title>
  <official_title>Painless Local Anaesthesia With Bicarbonate Admixture: A Phase II, Monocentric, Double-blind, Randomized, Placebo-controlled Crossover Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines whether the injection of local anesthesia mixed with sodium bicarbonate&#xD;
      in the ratio of 3:1 creates a less burning sensation and is as effective regarding the&#xD;
      anesthetic effect as in the ratio of 9:1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therefore the investigators compare two groups with 24 healthy individuals in each group in a&#xD;
      cross-over study. One group receives four injections (two in each forearm) and one group&#xD;
      receives only two injections (one in each forearm)&#xD;
&#xD;
      The four injections of group 1 are:&#xD;
&#xD;
        -  IMP1: Lidocaine and sodium bicarbonate ratio 3:1&#xD;
&#xD;
        -  IMP 2: Lidocaine and sodium bicarbonate ratio 9:1&#xD;
&#xD;
        -  IMP 3: Lidocaine&#xD;
&#xD;
        -  IMP 4: Sodium cloride 0.9% (=placebo)&#xD;
&#xD;
      The two injections of group 2 are IMP1 and IMP2.&#xD;
&#xD;
      After each injection the individual has to rate their pain sensation on a NRS scale and&#xD;
      afterwards the anesthetic effect gets tested by a standardized laser application.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">October 18, 2017</completion_date>
  <primary_completion_date type="Actual">October 18, 2017</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rating of injection pain between IMP1 and IMP2</measure>
    <time_frame>1 minute</time_frame>
    <description>on NRS scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rating of injection pain of IMP3 and IMP4</measure>
    <time_frame>1 minute</time_frame>
    <description>on NRS scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rating of clinical relevance of the difference between pain sensation of the injections</measure>
    <time_frame>5 minutes</time_frame>
    <description>participant can choose between four adjectives regarding injection pain:&#xD;
desirable&#xD;
acceptable&#xD;
less acceptable&#xD;
unacceptable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>assessment of local anesthesia of each injection with a standardized laser</measure>
    <time_frame>90 minutes</time_frame>
    <description>with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of anesthetic effect of each injection</measure>
    <time_frame>maximum 90 minutes</time_frame>
    <description>with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Local Infiltration</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.&#xD;
Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Consisting of 24 different individuals than those belonging to Group 1. Between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.&#xD;
Intervention: Every individual receives two injections:&#xD;
IMP 3 Lidocaine, and IMP 4 Sodium cloride 0.9% (=placebo), namely one in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the two areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine and sodium bicarbonate</intervention_name>
    <description>Lidocaine and sodium bicarbonate ratio 3:1</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine and sodium bicarbonate</intervention_name>
    <description>Lidocaine and sodium bicarbonate ratio 9:1</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lidocaine</intervention_name>
    <description>Lidocaine injection</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium cloride 0.9%</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy male or female individuals between 18 and 75 years&#xD;
&#xD;
          -  able to understand and speak German&#xD;
&#xD;
          -  able to follow the instructions&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  oversensitivity to lidocaine or other local anesthetics of amide type or sulfites&#xD;
&#xD;
          -  prone to bleeding, intake of aspirine or anticoagulation&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  skin on forearms with lesions (i.e. sunburn, wounds, eczema or other skin diseases)&#xD;
&#xD;
               -  previous participation at the same study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University hospital, Department of Dermatology</name>
      <address>
        <city>Zürich</city>
        <state>Zurich</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>June 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>December 19, 2017</last_update_submitted>
  <last_update_submitted_qc>December 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03238625
org study id: LIDOBICARB
nct id: NCT03238625
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study examines whether the injection of local anesthesia mixed with sodium bicarbonate
      in the ratio of 3:1 creates a less burning sensation and is as effective regarding the
      anesthetic effect as in the ratio of 9:1.
Therefore the investigators compare two groups with 24 healthy individuals in each group in a
      cross-over study. One group receives four injections (two in each forearm) and one group
      receives only two injections (one in each forearm)

      The four injections of group 1 are:

        -  IMP1: Lidocaine and sodium bicarbonate ratio 3:1

        -  IMP 2: Lidocaine and sodium bicarbonate ratio 9:1

        -  IMP 3: Lidocaine

        -  IMP 4: Sodium cloride 0.9% (=placebo)

      The two injections of group 2 are IMP1 and IMP2.

      After each injection the individual has to rate their pain sensation on a NRS scale and
      afterwards the anesthetic effect gets tested by a standardized laser application.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Rating of injection pain between IMP1 and IMP2
time frame: 1 minute
description: on NRS scale
measure: rating of injection pain of IMP3 and IMP4
time frame: 1 minute
description: on NRS scale
measure: rating of clinical relevance of the difference between pain sensation of the injections
time frame: 5 minutes
description: participant can choose between four adjectives regarding injection pain:
desirable
acceptable
less acceptable
unacceptable
measure: assessment of local anesthesia of each injection with a standardized laser
time frame: 90 minutes
description: with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
measure: duration of anesthetic effect of each injection
time frame: maximum 90 minutes
description: with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
arm group label: Group 1
arm group type: Active Comparator
description: Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.
arm group label: Group 2
arm group type: Placebo Comparator
description: Consisting of 24 different individuals than those belonging to Group 1. Between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine.
Intervention: Every individual receives two injections:
IMP 3 Lidocaine, and IMP 4 Sodium cloride 0.9% (=placebo), namely one in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the two areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.
intervention type: Drug
intervention name: Lidocaine and sodium bicarbonate
description: Lidocaine and sodium bicarbonate ratio 3:1
arm group label: Group 1
intervention type: Drug
intervention name: Lidocaine and sodium bicarbonate
description: Lidocaine and sodium bicarbonate ratio 9:1
arm group label: Group 1
intervention type: Drug
intervention name: Lidocaine
description: Lidocaine injection
arm group label: Group 1
arm group label: Group 2
intervention type: Drug
intervention name: Sodium cloride 0.9%
description: Placebo
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Lidocaine
sharing ipd: No