Anesthesia Clinical Trial
Official title:
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.
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.
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