The combination of local anaesthetics plus dexamethasone shall increase the duration of regional anaesthetic blocks. It is a volunteers´study. Three different block combination are performed. One block is performed with naropin as a single dose, one block with naropin and dexamethasone perineural and one block with naropin and dexamethason intravenous. Pinprick test and thumb adduction are performed for evaluation block success.
Conditions
Interventions
Trade Name: Dexabene
Product Name: dexamethason
Product Code: 1-20848
Pharmaceutical Form: Solution for injection
INN or Proposed INN: d
Sponsors
Medical University of Vienna, Department of Clinical Pharmacology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Healthy males • Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator • Signed written informed consent prior to inclusion in the study • 18-55 years old inclusive • Clearly detectable ulnar nerve at the non-dominant arm in ultrasound evaluation, according to the main investigators opinion (P.M.) • BMI: 18 to 35 kg/m2 • Ability to understand the full nature and purpose of the study, including possible risks and side effects • Ability to co-operate with the investigator and to comply with the requirements of the entire study • Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any clinically relevant abnormalities at ECG (12 leads) • Any clinically relevant abnormal physical findings • Any clinically relevant abnormal laboratory values indicative of physical illness • Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug • History of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study • If one of the investigated nerves are not clearly visible in ultrasound • Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study • Any psychiatric illnesses • Using other medications during 1 week before the start of IMP application including OTC • Participation in another clinical study investigating another IMP within 1 month prior to screening • Blood donations during 4 weeks prior to this study History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2015) • Other objections to study participation in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the impact of perineural dexamethasone on duration of sensory nerve blockade with clinical testing ;Secondary Objective: To evaluate the impact of perineural dexamethasone on sensory and motor onset times and the duration of motor blockade.; Primary end point(s): After performing the block the volunteers are tested motor and sensory block success at baseline, 2, 4, 6, 8, 10, 15, 20, 30, 60 min after the block, and then every 30 min until complete recovery. Motor blockade will be assessed via adduction of the thumb: - 3 = no difference, adduction against contra-force possible - 2 = slight difference, adduction against slight contra-force hardly possible - 1 = significant difference, adduction without contra-force hardly possible - 0 = no active adduction possible, paralysis Sensory blockade will be assessed via Pinprick testing at the hypothenar area in comparison with the contralateral side. Five areas of sensory supply are defined: - dorsal side hypothenar muscles - ulnar side hypothenar area - palmar side hypothenar muscles - fifth finger - ulnar side fourth finger. "0" means 0% sensory, 100% means complete sensory. Duration of sensory and motor block is defined as Pinprick = 20 in the hypothenar area and motor scale = 1. ;Timepoint(s) of evaluation of this end point: Motor and sensory block success are tested at baseline, 2, 4, 6, 8, 10, 15, 20, 30, 60 min after the block, and then every 30 min until complete recovery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The final visit at the end of the study takes place by a telephone call to evaluate ulnar nerve function and puncture site of the nerve block. ;Timepoint(s) of evaluation of this end point: The phone call will be performed up to 7 days after the last study period. | — |
Countries
Austria
Contacts
Public ContactDaniela Marhofer
Medical University of Vienna, Department of Anaesthesia, Intensive Care and Pain Medicine
Outcome results
None listed