NCT03430453

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

February 13, 2018

Status Verified

September 1, 2015

Enrollment Period

3.1 years

First QC Date

September 22, 2015

Last Update Submit

February 5, 2018

Conditions

Orthopedic Surgery

Keywords

Regional AnesthesiaUltrasound guidanceNerve stimulationOrthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • tissure pressure at the target

    estimated between 2 minutes and 20 minutes.

Study Arms (1)

Patient with ultrasound guided peripheral nerve blockade

EXPERIMENTAL

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

Interventions

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

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

Patient with ultrasound guided peripheral nerve blockade

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe coagulopathy
  • allergy to local anesthetics
  • local cutaneous lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital of Annecy

Annecy, France

Location

University hospital of Bordeaux

Bordeaux, France

Location

University hospital of Clermont-Ferrand

Clermont-Ferrand, France

Location

University Hospital of Colmar

Colmar, France

Location

University hospital of limoges

Limoges, France

Location

University hospital of Marseille

Marseille, France

Location

University Hospital of Montpellier

Montpellier, 34295, France

Location

University hospital of Nice

Nice, France

Location

University Hospital of Reims

Reims, France

Location

Related Publications (2)

  • Varobieff M, Choquet O, Swisser F, Coudray A, Menace C, Molinari N, Bringuier S, Capdevila X. Real-Time Injection Pressure Sensing and Minimal Intensity Stimulation Combination During Ultrasound-Guided Peripheral Nerve Blocks: An Exploratory Observational Trial. Anesth Analg. 2021 Feb 1;132(2):556-565. doi: 10.1213/ANE.0000000000005308.

    PMID: 33323786DERIVED

  • Capdevila M, Choquet O, Saporito A, Djanikian F, Swisser F, Marques M, Bringuier S, Capdevila X. Injection pressure monitoring during peripheral nerve blocks: from bench to operating theatre. Anaesth Crit Care Pain Med. 2020 Oct;39(5):603-610. doi: 10.1016/j.accpm.2020.03.022. Epub 2020 Aug 10.

    PMID: 32791158DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2015

First Posted

February 13, 2018

Study Start

May 1, 2012

Primary Completion

June 5, 2015

Study Completion

December 31, 2017

Last Updated

February 13, 2018

Record last verified: 2015-09

Locations

FR(9)