Anesthesia, Local Infiltration
Conditions
Brief 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.
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.
Interventions
DRUGLidocaine and sodium bicarbonate
Lidocaine and sodium bicarbonate ratio 3:1
DRUGLidocaine
Lidocaine injection
DRUGSodium cloride 0.9%
Placebo
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rating of injection pain between IMP1 and IMP2 | 1 minute | on NRS scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rating of injection pain of IMP3 and IMP4 | 1 minute | on NRS scale |
| rating of clinical relevance of the difference between pain sensation of the injections | 5 minutes | participant can choose between four adjectives regarding injection pain: * desirable * acceptable * less acceptable * unacceptable |
| assessment of local anesthesia of each injection with a standardized laser | 90 minutes | with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms |
| duration of anesthetic effect of each injection | maximum 90 minutes | with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms |
Countries
Switzerland
Outcome results
None listed