- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00213954
Ultrasound Guidance in Nerve Block Anaesthesia
February 24, 2009 updated by: University Hospital, Strasbourg, France
Ultrasound Guidance in Nerve Block Anaesthesia: Classic Nerve Stimulation Technique Versus Ultrasound-Neurostimulation Combination in Four Blocks: Interscalene, Humeral, Parasacral and Lumbar Blocks
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1002
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
-
-
-
Strasbourg, France, 67098
- Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
-
-
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:
- 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 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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: interscalene block
Locoregional anesthesia selection
|
Locoregional anesthesia with or without ultrasound guidance practice
|
Other: axillary block
Locoregional anesthesia selection
|
Locoregional anesthesia with or without ultrasound guidance practice
|
Other: lumbar block
Locoregional anesthesia selection
|
Locoregional anesthesia with or without ultrasound guidance practice
|
Other: parasacral plexus block
Locoregional anesthesia selection
|
Locoregional anesthesia with or without ultrasound guidance practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensory and motor block quality
Time Frame: 15, 30 and 60 min after the block is performed
|
15, 30 and 60 min after the block is performed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications
Time Frame: during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery
|
during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laurence LE GOURRIER, MD, Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
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
May 1, 2005
Primary Completion (Anticipated)
March 1, 2009
Study Completion (Anticipated)
September 1, 2009
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
February 25, 2009
Last Update Submitted That Met QC Criteria
February 24, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Other Study ID Numbers
- 3446
- 20050101
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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