NCT03238625

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2017

Completed
Last Updated

December 21, 2017

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

June 21, 2017

Last Update Submit

December 19, 2017

Conditions

Local InfiltrationAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Rating of injection pain between IMP1 and IMP2

    on NRS scale

    1 minute

Secondary Outcomes (4)

  • rating of injection pain of IMP3 and IMP4

    1 minute

  • rating of clinical relevance of the difference between pain sensation of the injections

    5 minutes

  • assessment of local anesthesia of each injection with a standardized laser

    90 minutes

  • duration of anesthetic effect of each injection

    maximum 90 minutes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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 bicarbonateDrug: LidocaineDrug: Sodium cloride 0.9%

Group 2

PLACEBO COMPARATOR

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: LidocaineDrug: Sodium cloride 0.9%

Interventions

Lidocaine and sodium bicarbonateDRUG

Lidocaine and sodium bicarbonate ratio 3:1

Group 1
LidocaineDRUG

Lidocaine injection

Group 1Group 2
Sodium cloride 0.9%DRUG

Placebo

Group 1Group 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy male or female individuals between 18 and 75 years
  • able to understand and speak German
  • able to follow the instructions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital, Department of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

LidocaineSodium Bicarbonate

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesBicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

August 3, 2017

Study Start

August 1, 2017

Primary Completion

October 18, 2017

Study Completion

October 18, 2017

Last Updated

December 21, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)