NCT03238625

Painless Local Anaesthesia With Bicarbonate Admixture

Painless Local Anaesthesia With Bicarbonate Admixture: A Phase II, Monocentric, Double-blind, Randomized, Placebo-controlled Crossover Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Local Infiltration
• Anesthesia

Interventions

Type	Name	Description
DRUG	Lidocaine and sodium bicarbonate	Lidocaine and sodium bicarbonate ratio 3:1
DRUG	Lidocaine and sodium bicarbonate	Lidocaine and sodium bicarbonate ratio 9:1
DRUG	Lidocaine	Lidocaine injection
DRUG	Sodium cloride 0.9%	Placebo

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-10-18
• Completion: 2017-10-18
• First posted: 2017-08-03
• Last updated: 2017-12-21

Locations

1 site across 1 country: Switzerland