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

February 5, 2018 updated by: University Hospital, Montpellier

Observational Study : Minimal Intensity of Stimulation During Ultrasound 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • University Hospital of Annecy
      • Bordeaux, France
        • University Hospital of Bordeaux
      • Clermont-Ferrand, France
        • University Hospital of Clermont-Ferrand
      • Colmar, France
        • University Hospital of Colmar
      • Limoges, France
        • University Hospital of Limoges
      • Marseille, France
        • University Hospital of Marseille
      • Montpellier, France, 34295
        • University Hospital of Montpellier
      • Nice, France
        • University Hospital of Nice
      • Reims, France
        • University Hospital of Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
estimated between 2 minutes and 20 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
estimated between 2 minutes and 20 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ACTUAL)

June 5, 2015

Study Completion (ACTUAL)

December 31, 2017

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

February 5, 2018

First Posted (ACTUAL)

February 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 5, 2018

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UF8924

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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