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Ultrasound Guidance in Nerve Block Anaesthesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by University Hospital, Strasbourg, France.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00213954
First received: September 13, 2005
Last updated: February 24, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention
Anesthesia
 Procedure: ultrasound-guidance with echography

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Ultrasound Guidance in Nerve Block Anaesthesia: Classic Nerve Stimulation Technique Versus Ultrasound-Neurostimulation Combination in Four Blocks: Interscalene, Humeral, Parasacral and Lumbar Blocks

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Sensory and motor block quality [ Time Frame: 15, 30 and 60 min after the block is performed ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complications [ Time Frame: during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1002
Study Start Date: May 2005
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
interscalene block
Locoregional anesthesia selection
 Procedure: ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice
axillary block
Locoregional anesthesia selection
 Procedure: ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice
lumbar block
Locoregional anesthesia selection
 Procedure: ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice
parasacral plexus block
Locoregional anesthesia selection
 Procedure: ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Block's contraindications, treatment by verapamil or flecainide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213954

Locations
France
Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Laurence LE GOURRIER, MD Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
  More Information

No publications provided

Responsible Party: Christine GEILLER, Direction de la Recherche Clinique et de l'Innovation - Hôpitaux Universitaires de Strasbourg
ClinicalTrials.gov Identifier: NCT00213954     History of Changes
Other Study ID Numbers: 3446, 20050101
Study First Received: September 13, 2005
Last Updated: February 24, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Strasbourg, France:
Nerve block anaesthesia
ultrasound-guidance

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013