Clinical trial NCT03797235: The Impact of Nerve Cross Section Area on Sensory Block Onset
Official title: The Impact of Nerve Cross Section Area on Sensory Block Onset. A Prospective, Monocentric Crossover Study on Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia
Keywords: Ultrasound-guided regional anesthesia
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study aims to describe a correlation between the nerve cross section and the sensory or motor block onset time. Therefore, different nerve cross sections with their Motor and sensory onset times are compared in order to find a correlation.

In the case of discovering a correlation, this could be translated into clinical practice, where a more tailored and individualized approach to performing peripheral nerve blocks would be possible, thus lowering the risks of adverse events occurring.


Eligibility criteria: Inclusion Criteria:

* ASA I - II, both sexes
* ≥ 18 years old
* \< 65 years old
* Written informed consent as documented by signature

Exclusion Criteria:

* Known allergy or hypersensitivity to a study drug or class of drug.
* Severe coagulopathy.
* History of alcohol abuse or the intake of psychotropic drugs.
* Pregnancy.
* Infection at the injection site or a systemic infection.
* Fever of unknown origin.
* Motor or sensory abnormalities in the arm.
* Previous enrollment into the current study

Primary outcomes:
measure: Correlation between nerve cross-section and time to complete sensory block of a nerve
timeFrame: Sensory evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete sensory loss to both cold and pinprick. Expected time frame: 10-60 minutes
Secondary outcomes:
measure: Correlation between nerve cross-section and time to complete motor block of a nerve
timeFrame: Motor evaluation will be carried out before the block and every 2 minutes after the start of the injection of LA until complete motor block. Expected time frame: 10-100 minutes
measure: Correlation between nerve cross-section and the duration of sensory nerve block
timeFrame: The evaluation of the duration of block will start one hour after the determined complete sensory loss and will be tested every 10 minutes until complete resolution of the sensory block. Expected time frame: 10-300 minutes
measure: Correlation between the nerve cross-section and duration of motor nerve block
timeFrame: The evaluation of the duration of sensory block will start one hour after the determined complete motor loss and will be tested every 10 minutes until complete resolution of the motor block. Expected time frame: 10-300min
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Der Balgrist
Study officials:
affiliation: Der Balgrist
name: José Aguirre, PD Dr Med
role: PRINCIPAL_INVESTIGATOR
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