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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03238625
Other study ID # LIDOBICARB
Secondary ID
Status Completed
Phase Phase 2
First received June 21, 2017
Last updated December 19, 2017
Start date August 1, 2017
Est. completion date October 18, 2017

Study information

Verified date December 2017
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 18, 2017
Est. primary completion date October 18, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Switzerland University hospital, Department of Dermatology Zürich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rating of injection pain between IMP1 and IMP2 on NRS scale 1 minute
Secondary rating of injection pain of IMP3 and IMP4 on NRS scale 1 minute
Secondary rating of clinical relevance of the difference between pain sensation of the injections participant can choose between four adjectives regarding injection pain:
desirable
acceptable
less acceptable
unacceptable
5 minutes
Secondary assessment of local anesthesia of each injection with a standardized laser with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms 90 minutes
Secondary duration of anesthetic effect of each injection with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms maximum 90 minutes
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