Local anesthetics for minor or more major procedures such as suturing lacerations, removing skin lesions, operating ingrown toenails, drilling and removing teeth etc. MedDRA version: 20.0 Level: LLT Classification code 10024760 Term: Local anesthetic System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Xylocain 10 mg/ml
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: LIDOCAINE HYDROCHLORIDE
Other descriptive name: Lidokainhydroklorid
Concentration unit: mg/ml mi
Sponsors
Institute for Public Health and Caring Sciences, Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-65 • Patient report of a decreased effect of local anesthetics, • Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous adverse reaction to local anesthetics (not including decreased effect) • Injury, infection or peripheral nerve injury in the experimental sites • Diabetes or medical conditions not suitable for participation in the study • Use of anticoagulants • Difficulty to understand written and spoken Swedish.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The first sensory testing will be done before injection and will then be repeated six times, i.e. every 10 minutes during one hour. Quantitative Sensory Testing (QST): With a thermode connected to a computer that cycles warm or cold temperatures to a skin region, these can be tested. From a baseline of 32oC, temperatures are increased or decreased by 1oC/sec. to a maximum of 50oC for warmth and a minimum of 10oC for cold. The subjects indicate with a handheld switch. ;Main Objective: To identify if a decreased or absent effect of local anesthetics in producing skin anesthesia is present in a group of patients by measuring sensitivity for light stroking, pinprick, warm, cold and possible warm and cold pain using objective sensoric tests. ;Secondary Objective: To evaluate the safety profile of Lidocain by reporting of Adverse Events with a possible/probable relationship to the study medication.;Primary end point(s): Measuring changes in sensitivity for • light stroking • pinprick • warm, cold and possible warm and cold pain: Quantitative sensory testing (QST). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of Adverse Events / Serious Adverse Events with possible or probable relationship to the study medication.;Timepoint(s) of evaluation of this end point: From administration of lidocaine until end of study, or until the patient reports an event occurring after study visit. | — |
Countries
Sweden
Contacts
Public ContactSponsor
Institute for Public Health and Caring Sciences, Uppsala University
Outcome results
None listed