Painless Local Anaesthesia With Bicarbonate Admixture

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.

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