Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2017-08-01
2017-10-18
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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.
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
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.
Lidocaine
Lidocaine injection
Sodium cloride 0.9%
Placebo
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* able to understand and speak German
* able to follow the instructions
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Locations
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University hospital, Department of Dermatology
Zurich, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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LIDOBICARB
Identifier Type: -
Identifier Source: org_study_id