Monitoring of Intensity of Stimulation and Injection Pressure in US Guided Peripheral Nerve Block According to Anatomic Needle Type Position

Orthopedic Surgery Clinical Trial

Official title:

Observational Study : Minimal Intensity of Stimulation During Ultrasound Guided Peripheral Nerve Block According to Anatomic Needle Type Position

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03430453
• Other study ID #: UF8924
• Status: Completed
• Phase: N/A
• First received: September 22, 2015
• Last updated: February 5, 2018
• Start date: May 1, 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2015
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 31, 2017
• Est. primary completion date: June 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthopedic Surgery

Intervention

Procedure:
• Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade
A 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 Minimal Intensity of Stimulation is recorded before injection of local anesthetic

Locations

Country	Name	City	State
France	University Hospital of Annecy	Annecy
France	University hospital of Bordeaux	Bordeaux
France	University hospital of Clermont-Ferrand	Clermont-Ferrand
France	University Hospital of Colmar	Colmar
France	University hospital of limoges	Limoges
France	University hospital of Marseille	Marseille
France	University Hospital of Montpellier	Montpellier
France	University hospital of Nice	Nice
France	University Hospital of Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Minimum Intensity Stimulation	Minimal Intensity Stimulation (MIS) was measured Using a specific nerve stimulator (modified HNS 12 B. BRAUN, Melsungen, Germany) ; the value are noted in mA. [0- 1.5].; The time frame is only related to procedure of PNB. In other term, the period of assessment should be estimated between 2 minutes and 20 minutes.	estimated between 2 minutes and 20 minutes.
Secondary	tissure pressure at the target	Tissue pressure at the target was measured Using a specific pressure sensor (compuflow pump Milestone Scientific, Livingston, NJ, USA) ; the value are noted in mm Hg. [0- 900].; from beginning to end of ultrasound guided peripheral nerve blockade	estimated between 2 minutes and 20 minutes.