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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Local Infiltration
• Intervention / Treatment: Drug: Lidocaine and sodium bicarbonate; Drug: Lidocaine and sodium bicarbonate; Drug: Lidocaine; Drug: Sodium cloride 0.9%

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8091
      • University Hospital, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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.	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
Placebo Comparator: Group 2; 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.	Drug: Lidocaine; Lidocaine injection; Drug: Sodium cloride 0.9%; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating of injection pain between IMP1 and IMP2	on NRS scale	1 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rating of injection pain of IMP3 and IMP4	on NRS scale	1 minute
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
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
duration of anesthetic effect of each injection	with Palomoar Synosure non-ablative Fractional CO2-Laser with 30 mJ, 15 ms	maximum 90 minutes

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): October 18, 2017
• Study Completion (Actual): October 18, 2017

Study Registration Dates

• First Submitted: June 21, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: LIDOBICARB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No