Median NerveEchoalrNCT00651170
Diffusion of Local Anesthetic After Median Nerve Block
An observational study of Median Nerve, run by Hopital Foch at 2 sites in France.
Trial summary
Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in orthopedic surgery. Even realised by experienced anaesthetists,a failure rate of 5-15% is noticed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Median Nerve
- How many people
- 103 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2008to Mar 2009
- Phase
- Observational
- 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
Study population: primary care clinic
Who may be able to join
- Patients undergoing elective hand surgery requiring a median block nerve.
Who cannot join
- age lower than 18 years
- pregnancy
- contraindication to nerve block
- inability to read, write or speak French
- mental illness.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Foch
Suresnes, 92151
Hôpital privé de l'Ouest Parisien
Trappes, 78195
About this study
Official title: Can Ultrasound Predict Success of Median Nerve Block? Relationship Between Diffusion of Local Anesthetic and Effectiveness of a Nerve Block
Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in orthopedic surgery. Even realised by experienced anaesthetists,a failure rate of 5-15% is noticed. The principal aim of the study is to observe the local anesthetic solution diffusion after a conventional median nerve block technique using neurostimulation. The secondary objective is to compare diffusion and of block efficacy..
- Conditions
- Median Nerve
- Keywords
- Median block nerve, Ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesic diffusion degree
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Median NerveStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, Study chair, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651170
- Sponsor's protocol ID
- 2008/01
- Acronym
- Echoalr
- Status last verified
- Sep 2016
- First submitted
- 28 Mar 2008
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Ultrasound Predict Success of Median Nerve Block? Relationship Between Diffusion of Local Anesthetic and Effectiveness of a Nerve Block
- ClinicalTrials.gov ID
- NCT00651170
- Acronym / sponsor ID
- Echoalr / 2008/01
- Conditions
- Median Nerve
- Keywords
- Median block nerve, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Apr 2008 (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.
Median nerve block is widely practised, avoiding general anaesthesia in a number of cases and producing excellent post-operative analgesia in orthopedic surgery. Even realised by experienced anaesthetists,a failure rate of 5-15% is noticed. The principal aim of the study is to observe the local anesthetic solution diffusion after a conventional median nerve block technique using neurostimulation. The secondary objective is to compare diffusion and of block efficacy..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- Patients undergoing elective hand surgery requiring a median block nerve.
Key exclusion criteria (5 listed)
- age lower than 18 years
- pregnancy
- contraindication to nerve block
- inability to read, write or speak French
- mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anesthesic diffusion degree
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Individual participant dataSharing planned: No
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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.
Marc Fischler study chair
Hopital Foch
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Median Nerve, run by Hopital Foch at 2 sites 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 5 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: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anesthesic diffusion degree (time frame: 1 hour). 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 26 Sep 2016.