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Completed

NCT Number: NCT03238625

Painless Local Anaesthesia With Bicarbonate Admixture

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.

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Key information

Conditions

Local Infiltration Anesthesia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University hospital, Department of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine and sodium bicarbonate

Drug

Lidocaine and sodium bicarbonate ratio 3:1

Lidocaine

Drug

Lidocaine injection

Sodium cloride 0.9%

Drug

Placebo

Primary outcomes

  1. Rating of injection pain between IMP1 and IMP2

    Time frame: 1 minute

    on NRS scale

Secondary outcomes

  1. rating of injection pain of IMP3 and IMP4

    Time frame: 1 minute

    on NRS scale

  2. rating of clinical relevance of the difference between pain sensation of the injections

    Time frame: 5 minutes

    participant can choose between four adjectives regarding injection pain:

    • desirable
    • acceptable
    • less acceptable
    • unacceptable

  3. assessment of local anesthesia of each injection with a standardized laser

    Time frame: 90 minutes

    with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms

  4. duration of anesthetic effect of each injection

    Time frame: maximum 90 minutes

    with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2017
Registry last updated
Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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