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Completed

NCT Number: NCT03430453

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

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

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Key information

Conditions

Orthopedic Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Annecy, Annecy, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade

Procedure

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

Primary outcomes

  1. Measurement of Minimum Intensity Stimulation

    Time frame: 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 outcomes

  1. tissure pressure at the target

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Feb 13, 2018
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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