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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Lidocaine and sodium bicarbonate ratio 3:1
Lidocaine and sodium bicarbonate ratio 9:1
Lidocaine injection
University hospital, Department of Dermatology
Zurich, Canton of Zurich, Switzerland
Rating of injection pain between IMP1 and IMP2
on NRS scale
Time frame: 1 minute
rating of injection pain of IMP3 and IMP4
on NRS scale
Time frame: 1 minute
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
Time frame: 5 minutes
assessment of local anesthesia of each injection with a standardized laser
with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
Time frame: 90 minutes
duration of anesthetic effect of each injection
with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms
Time frame: maximum 90 minutes
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Placebo