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

Not Applicable

Completed

• Conditions: Orthopedic Surgery
• Interventions: Procedure: Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade

• Registration Number: NCT03430453
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study Start: 2012-05-01
• Primary Completion: 2015-06-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-22
• Study Completion: 2017-12-31
• Study First Submitted QC: 2018-02-05
• Last Update Submitted: 2018-02-05
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with ultrasound guided peripheral nerve blockade	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.

Primary Outcome Measures

Name	Time	Method
Measurement of Minimum Intensity Stimulation	estimated between 2 minutes and 20 minutes.	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.

Secondary Outcome Measures

Name	Time	Method
tissure pressure at the target	estimated between 2 minutes and 20 minutes.	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

Trial Locations

Locations (9)

University hospital of Bordeaux; 🇫🇷 Bordeaux, France

University hospital of Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

University Hospital of Colmar; 🇫🇷 Colmar, France

University hospital of Nice; 🇫🇷 Nice, France

University Hospital of Reims; 🇫🇷 Reims, France

University Hospital of Annecy; 🇫🇷 Annecy, France

University hospital of limoges; 🇫🇷 Limoges, France

University hospital of Marseille; 🇫🇷 Marseille, France

University Hospital of Montpellier; 🇫🇷 Montpellier, France