Painless Local Anaesthesia With Bicarbonate Admixture

December 19, 2017 updated by: University of Zurich

Painless Local Anaesthesia With Bicarbonate Admixture: A Phase II, Monocentric, Double-blind, Randomized, Placebo-controlled Crossover Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zurich
      • Zürich, Zurich, Switzerland, 8091
        • University Hospital, Department of Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy male or female individuals between 18 and 75 years
  • able to understand and speak German
  • able to follow the instructions

Exclusion criteria:

  • oversensitivity to lidocaine or other local anesthetics of amide type or sulfites
  • prone to bleeding, intake of aspirine or anticoagulation
  • pregnancy

  • skin on forearms with lesions (i.e. sunburn, wounds, eczema or other skin diseases)

    • previous participation at the same study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group 1

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.
Drug: Lidocaine and sodium bicarbonate
Lidocaine and sodium bicarbonate ratio 3:1
Drug: Lidocaine and sodium bicarbonate
Lidocaine and sodium bicarbonate ratio 9:1
Drug: Lidocaine
Lidocaine injection
Drug: Sodium cloride 0.9%
Placebo
Placebo Comparator: Group 2

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.
Drug: Lidocaine
Lidocaine injection
Drug: Sodium cloride 0.9%
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rating of injection pain between IMP1 and IMP2
Time Frame: 1 minute
on NRS scale
1 minute

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
rating of injection pain of IMP3 and IMP4
Time Frame: 1 minute
on NRS scale
1 minute
rating of clinical relevance of the difference between pain sensation of the injections
Time Frame: 5 minutes

participant can choose between four adjectives regarding injection pain:

  • desirable
  • acceptable
  • less acceptable
  • unacceptable
5 minutes
assessment of local anesthesia of each injection with a standardized laser
Time Frame: 90 minutes
with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
90 minutes
duration of anesthetic effect of each injection
Time Frame: maximum 90 minutes
with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
maximum 90 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LIDOBICARB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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