AnesthesiaNCT00213954
Ultrasound Guidance in Nerve Block Anaesthesia
A study testing ultrasound-guidance with echography in people with Anesthesia, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- ultrasound-guidance with echography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 1 siteFrance
- Study dates
- May 2005to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Block's contraindications, treatment by verapamil or flecainide
Trial locations and contacts
1 site in 1 country.
France1 site
Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
Strasbourg, 67098
About this study
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
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.
- Conditions
- Anesthesia
- Being tested
- ultrasound-guidance with echography
- Keywords
- Nerve block anaesthesia, ultrasound-guidance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guidance with echographyProcedure or surgery
Locoregional anesthesia with or without ultrasound guidance practice
| Study group | Role | What they receive |
|---|---|---|
| interscalene block | Other | Locoregional anesthesia selection Receives: Procedure: ultrasound-guidance with echography |
| axillary block | Other | Locoregional anesthesia selection Receives: Procedure: ultrasound-guidance with echography |
| lumbar block | Other | Locoregional anesthesia selection Receives: Procedure: ultrasound-guidance with echography |
| parasacral plexus block | Other | Locoregional anesthesia selection Receives: Procedure: ultrasound-guidance with echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory and motor block quality
Measured: 15, 30 and 60 min after the block is performed
Secondary outcomes (1)
Complications
Measured: during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,002 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Laurence LE GOURRIER, MD, Principal investigator, Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213954
- Sponsor's protocol ID
- 3446
- Other IDs
- 20050101
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00213954
- Acronym / sponsor ID
- 3446
- Conditions
- Anesthesia
- Keywords
- Nerve block anaesthesia, ultrasound-guidance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,002 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Mar 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| interscalene block | Other | Procedure: ultrasound-guidance with echographyLocoregional anesthesia selection |
| axillary block | Other | Procedure: ultrasound-guidance with echographyLocoregional anesthesia selection |
| lumbar block | Other | Procedure: ultrasound-guidance with echographyLocoregional anesthesia selection |
| parasacral plexus block | Other | Procedure: ultrasound-guidance with echographyLocoregional anesthesia selection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Block's contraindications, treatment by verapamil or flecainide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guidance with echographyLocoregional anesthesia with or without ultrasound guidance practice | Procedure or surgery | axillary block, interscalene block, lumbar block, parasacral plexus block |
Primary outcome
Sensory and motor block quality
Time frame: 15, 30 and 60 min after the block is performed
1 secondary outcome
Complications
Time frame: during the hospitalisation and by phone 1, 3, 6 and 9 months after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence LE GOURRIER, MD principal investigator
Unité d'Anesthésiologie et de Réanimation Chirurgicale, Hôpital de Hautepierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guidance with echography in people with Anesthesia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory and motor block quality (time frame: 15, 30 and 60 min after the block is performed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2009.