ocal anaesthetic injections of the nerves of the upper arm and changes in blood circulation. Comparing effects of lidocain with epinephrine versus withoutepinephrine.
- Conditions
- human microcirculation and haemodynamic changes (macrosirculation) in healthy volunteers.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2012-005651-17-NO
- Lead Sponsor
- Oslo Universitetssykehus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
We will include 12 healthy volunteers in each study, age 18 – 60, ASA 1-2. Non-smokers. No intake of coffee, black tea or garlic last 12 hours. No regular medication. BMI 18-35.
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 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
Known allergy against lidocain. Volunteers with neurological decease, diabetes, nerve- or vascular impairment at the upper limb are not included.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To establish the effect of epinephrine when added to lidocain in brachial plexus block on human skin microcirculation and haemodynamic changes (macrosirculation) in men.;Secondary Objective: Not applicable;Primary end point(s): Comparing effects on microcirculation and macrocirculation of lidocain brachial plexus block with epinephrine versus without epinephrine.;Timepoint(s) of evaluation of this end point: 40 minutes
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Comparation of different methods for circulation monitoring (laser doppler, temperature, capillary microscopy and spectroscopy, beat-to-beat Finometer measurements).;Timepoint(s) of evaluation of this end point: 40 min