Ultrasound Guidance in Nerve Block Anaesthesia

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00213954
• Other study ID #: 3446
• Secondary ID: 20050101
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: February 24, 2009
• Start date: May 2005
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1002
• Est. completion date: September 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia

Intervention

Procedure:
• ultrasound-guidance with echography
Locoregional anesthesia with or without ultrasound guidance practice

Locations

Country	Name	City	State
France	Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory and motor block quality		15, 30 and 60 min after the block is performed	Yes
Secondary	Complications		during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery	Yes