To evaluate the pharmacodynamic effects of perineural administered liposomal bupivacaine on nerve block characteristics
Conditions
Interventions
Trade Name: Exparel
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: Bupivacaine
CAS Number: 2180-92-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Con
Sponsors
Medical University Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Healthy males and females • 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 • 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 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
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 • Pregnancy and breastfeeding • Any psychiatric illnesses • Any anticoagulatory or pain-therapy-related drugs (e.g. NSAIDs, opioids) from one week before until the end of the study • 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 (more than 2 glasses of either a small beer, 1/8 L wine or 2 cL spirits per day) • Other objections to study participation in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: Duration of sensory nerve blockade ;Secondary Objective: Secondary Objective: Duration of motor blockade Onset time of sensory nerve blockade Onset time of motor blockade;Primary end point(s): To assess the nerve block the following tests will be performed: Sensory blockade will be evaluated via Pinprick testing (0 = no sensory feeling, 100 = no difference in sensory feeling to the corresponding non-blocked side) at the hypothenar area compared with the corresponding non-blocked side. Motor blockade will be evaluated 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 Onset of sensory and motor block is defined as Pinprick = 0 in the hypothenar area (4 from 5 above-described areas to consider anatomical variations) and motor scale = 0. Duration of sensory and motor block is defined as Pinprick testing = back to 80 in the hypothenar area and motor scale = back to 1. The primary endpoint is the duration of sensory block and it is defined as Pinprick testing = 80 in the hypothenar area. ;Timepoint(s) of evaluation of this end point: Sensory testing will be performed at the following time points (min): Baseline, 2, 4, 6, 8, 10, 15, 20, 30, 60 min after the block, and then every 60 min until Pinprick testing = 80. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of motor block Onset time of sensory nerve blockade Onset time of motor blockade;Timepoint(s) of evaluation of this end point: Sensory and motor testing will be performed at the following time points (min): Baseline, 2, 4, 6, 8, 10, 15, 20, 30, 60 min after the block, and then every 60 min until Pinprick testing = 80 and motor-scale = 1. Onset of sensory and motor block is defined as Pinprick = 0 in the hypothenar area (4 from 5 above-described areas to consider anatomical variations) and motor scale = 0. Duration of motor block is defined as motor scale = back to 1. | — |
Countries
Austria
Contacts
Public ContactDepartment of Clinical Pharmcology
Medical University Vienna
Outcome results
None listed