Painless Local Anaesthesia With Bicarbonate Admixture

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238625
• Other study ID #: LIDOBICARB
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2017
• Last updated: December 19, 2017
• Start date: August 1, 2017
• Est. completion date: October 18, 2017

Study information

• Verified date: December 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 18, 2017
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Local Infiltration

Intervention

Drug:
• Lidocaine and sodium bicarbonate
Lidocaine and sodium bicarbonate ratio 3:1
• Lidocaine and sodium bicarbonate
Lidocaine and sodium bicarbonate ratio 9:1
• Lidocaine
Lidocaine injection
• Sodium cloride 0.9%
Placebo

Locations

Country	Name	City	State
Switzerland	University hospital, Department of Dermatology	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of injection pain between IMP1 and IMP2	on NRS scale	1 minute
Secondary	rating of injection pain of IMP3 and IMP4	on NRS scale	1 minute
Secondary	rating of clinical relevance of the difference between pain sensation of the injections	participant can choose between four adjectives regarding injection pain: desirable; acceptable; less acceptable; unacceptable	5 minutes
Secondary	assessment of local anesthesia of each injection with a standardized laser	with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms	90 minutes
Secondary	duration of anesthetic effect of each injection	with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms	maximum 90 minutes