NCT00213954

Brief Summary

Nerve block anaesthesia is wildly practised in France, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in trauma and orthopaedic surgeries. Even realised by experimented anaesthetists, 5-15% of failures and rare complications (such as vascular puncture, paresthesia, systemic local anaesthetic toxicity, epidural and spinal anaesthesia, neuropathy) are noticed. The aim of the study is the evaluation of an ultrasound-guidance technique in the four predetermined blocks and the incidence of their complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,002

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 25, 2009

Status Verified

February 1, 2009

Enrollment Period

3.8 years

First QC Date

September 13, 2005

Last Update Submit

February 24, 2009

Conditions

Keywords

Nerve block anaesthesiaultrasound-guidance

Outcome Measures

Primary Outcomes (1)

  • Sensory and motor block quality

    15, 30 and 60 min after the block is performed

Secondary Outcomes (1)

  • Complications

    during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery

Study Arms (4)

interscalene block

OTHER

Locoregional anesthesia selection

Procedure: ultrasound-guidance with echography

axillary block

OTHER

Locoregional anesthesia selection

Procedure: ultrasound-guidance with echography

lumbar block

OTHER

Locoregional anesthesia selection

Procedure: ultrasound-guidance with echography

parasacral plexus block

OTHER

Locoregional anesthesia selection

Procedure: ultrasound-guidance with echography

Interventions

Locoregional anesthesia with or without ultrasound guidance practice

axillary blockinterscalene blocklumbar blockparasacral plexus block

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 years and greater, scheduled for one of these blocks: interscalene, humeral, parasacral or lumbar blocks, for trauma or orthopaedic surgeries, who have consented to the study and are with social insurance registration

You may not qualify if:

  • Block's contraindications, treatment by verapamil or flecainide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre

Strasbourg, 67098, France

Location

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Laurence LE GOURRIER, MD

    Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2005

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

February 25, 2009

Record last verified: 2009-02

Locations