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

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ClinicalTrials.gov Identifier: NCT03430453
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Orthopedic Surgery Procedure: Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Observational Study : Minimal Intensity of Stimulation During Ultrasound Guided Peripheral Nerve Block According to Anatomic Needle Type Position
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : June 5, 2015
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Patient with 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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430453


Locations
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, 34295
University hospital of Nice
Nice, France
University Hospital of Reims
Reims, France
Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03430453     History of Changes
Other Study ID Numbers: UF8924
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: September 2015

Keywords provided by University Hospital, Montpellier:
Regional Anesthesia
Ultrasound guidance
Nerve stimulation
Orthopedic surgery