Painless Local Anaesthesia With Bicarbonate Admixture

University of Zurich (UZH)

Status and phase: Completed; Phase 2

Conditions: Local Infiltration; Anesthesia

Treatments: Drug: Lidocaine and sodium bicarbonate; Drug: Lidocaine; Drug: Sodium cloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT03238625

LIDOBICARB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Group 1

Active Comparator group

Description:

Consisting of 24 individuals between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine. Intervention: Every individual receives four injections IMP1: Lidocaine and sodium bicarbonate ratio 3:1, IMP 2: Lidocaine and sodium bicarbonate ratio 9:1, IMP 3: Lidocaine, and IMP 4: Sodium cloride 0.9% (=placebo), namely two in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the four areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.

Treatment:

Drug: Sodium cloride 0.9%

Drug: Lidocaine and sodium bicarbonate

Drug: Lidocaine

Drug: Lidocaine and sodium bicarbonate

Group 2

Placebo Comparator group

Description:

Consisting of 24 different individuals than those belonging to Group 1. Between 18 and 75 years, able to understand German, not pregnant, with no intolerance of local anesthetics, with intact skin and no skin diseases, not prone to bleeding or taking anticoagulation or aspirine. Intervention: Every individual receives two injections: IMP 3 Lidocaine, and IMP 4 Sodium cloride 0.9% (=placebo), namely one in every volar forearm, and has to rate the pain associated during the injection of the fluid, not the needle stitch. Afterwards the anesthetic effect on the two areals which got injected will be checked with a palomar laser after 5, 30, 60, 90, 120 and 180 minutes.

Treatment:

Drug: Sodium cloride 0.9%

Drug: Lidocaine