Clinical trial NCT03430453: Monitoring of Intensity of Stimulation and Injection Pressure in US Guided Peripheral Nerve Block According to Anatomic Needle Type Position
Official title: Observational Study : Minimal Intensity of Stimulation During Ultrasound Guided Peripheral Nerve Block According to Anatomic Needle Type Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Surgery
Keywords: Regional Anesthesia
Ultrasound guidance
Nerve stimulation
Orthopedic surgery
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is define the minimal intensity of stimulation range at which the needle is closed to the nerve without penetrating its surface (epineurium layer) in ultrasound guided peripheral nerve blockade

Detailed description: The needle is placed at the target under ultrasound guidance the nerve stimulator is turned on and the intensity increased until motor response is observed the Minimum Intensity Observation (MIS) is recorded before injection of local anesthetic

Eligibility criteria: Inclusion Criteria:

* Patient who need a Orthopedic surgery
* Peripheral nerve block
* More or equal to 18 years old
* I to III ASA classification status
* Benefit from an insurance regimen

Exclusion Criteria:

* severe coagulopathy
* allergy to local anesthetics
* local cutaneous lesion

Primary outcomes:
measure: Measurement of Minimum Intensity Stimulation
timeFrame: estimated between 2 minutes and 20 minutes.
Secondary outcomes:
measure: tissure pressure at the target
timeFrame: estimated between 2 minutes and 20 minutes.
Other outcomes:
Locations:
city: Annecy
country: France
facility: University Hospital of Annecy
city: Bordeaux
country: France
facility: University hospital of Bordeaux
city: Clermont-Ferrand
country: France
facility: University hospital of Clermont-Ferrand
city: Colmar
country: France
facility: University Hospital of Colmar
city: Limoges
country: France
facility: University hospital of limoges
city: Marseille
country: France
facility: University hospital of Marseille
city: Montpellier
country: France
facility: University Hospital of Montpellier
city: Nice
country: France
facility: University hospital of Nice
city: Reims
country: France
facility: University Hospital of Reims
Study officials:
References:
citation: Varobieff M, Choquet O, Swisser F, Coudray A, Menace C, Molinari N, Bringuier S, Capdevila X. Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial. Anesth Analg. 2021 Feb 1;132(2):556-565. doi: 10.1213/ANE.0000000000005308.
citation: Capdevila M, Choquet O, Saporito A, Djanikian F, Swisser F, Marques M, Bringuier S, Capdevila X. Injection pressure monitoring during peripheral nerve blocks: from bench to operating theatre. Anaesth Crit Care Pain Med. 2020 Oct;39(5):603-610. doi: 10.1016/j.accpm.2020.03.022. Epub 2020 Aug 10.