Nerve BlockPhase 4Hydro-EchoNCT01058525
Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency
A Phase 4 study testing median nerve block and median nerve block after hydro-dissection in people with Nerve Block, run by Hopital Foch at 1 site in France.
Trial summary
The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can be challenging. These difficulties may partly explain the systemic complications of local anesthetics under ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- median nerve block and median nerve block after hydro-dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jan 2011
- Phase
- Phase 4
- 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
- Adult patients with an ASA physical status I-II scheduled for elective ambulatory surgery of the hand or wrist involving the median nerve
Who cannot join
- Patients with type 1 or 2 diabetes mellitus,
- History of clinical or laboratory evidence of abnormal bleeding,
- Infection at the injection site,
- Allergy to local anesthetic,
- Preexisting central or peripheral muscular or neurological disease (for example: carpal tunnel syndrome)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study
The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can be challenging. These difficulties may partly explain the systemic complications of local anesthetics under ultrasound. Injection of small amounts of a solution around the anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its borders and also to improve the visualization of the needle tip. The glucose solution 5% solution is interesting because it allows, unlike saline, to maintain the motor response with neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated from the vessels, injection of local anesthetic is performed in the circumferential diffusion space (like a small pocket) without redirecting needle.
The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve block quality can be improved because the entire anesthetic is injected in contact with the nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose solution.
In this randomized study, the investigators test the hypothesis that hydro-dissection does not alter the nerve block onset time.
- Conditions
- Nerve Block
- Being tested
- median nerve block, median nerve block after hydro-dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
median nerve blockProcedure or surgery
median nerve block performed using ultrasound guidance
median nerve block after hydro-dissectionProcedure or surgery
median nerve block performed after hydro-dissection (glucose 5% solution), both using ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| nerve block | Active comparator | median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000) Receives: Procedure: median nerve block |
| median nerve block after hydro-dissection | Experimental | median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000) after hydro-dissection (glucose 5% solution) Receives: Procedure: median nerve block after hydro-dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)
Measured: 30 minutes after injection
Secondary outcomes (8)
Onset time of sensory blockade (cold test at index finger and thenar eminence)
Measured: 30 minutes after injection
Onset time (light touch test at thenar eminence)
Measured: 30 minutes after injection
Onset time for motor blockade
Measured: 30 minutes after injection
Success rate (% of patients with total light touch block at index finger within 30 min evaluation period)
Measured: 30 minutes after injection
Successful surgical anesthesia
Measured: 30 minutes after injection
Duration of nerve blockade
Measured: 12 hours
Nerve block complication
Measured: one month
Duration of the puncture procedure
Measured: 30 minutes after the beginning of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058525
- Sponsor's protocol ID
- 2009/27
- Acronym
- Hydro-Echo
- Status last verified
- Sep 2016
- First submitted
- 27 Jan 2010
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dufour E, Donat N, Jaziri S, Kurdi O, Couturier C, Dreyfus JF, Fischler M. Ultrasound-guided perineural circumferential median nerve block with and without prior dextrose 5% hydrodissection: a prospective randomized double-blinded noninferiority trial. Anesth Analg. 2012 Sep;115(3):728-33. doi: 10.1213/ANE.0b013e31825fa37d. Epub 2012 Jun 28.
PubMed 22745114
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT01058525
- Acronym / sponsor ID
- Hydro-Echo / 2009/27
- Conditions
- Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 28 Jan 2010 (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.
The real-time visualization of a needle and nerve during an ultrasound-guided nerve block can be challenging. These difficulties may partly explain the systemic complications of local anesthetics under ultrasound. Injection of small amounts of a solution around the anesthetized nerve (hydro-dissection) has been proposed to enhance contrast outlining its borders and also to improve the visualization of the needle tip. The glucose solution 5% solution is interesting because it allows, unlike saline, to maintain the motor response with neurostimulation. The hydro-dissection can be particularly useful when one suspect hypoechoic vessels near the nerve to be anesthetized. Thereby, the nerve well demarcated and separated from the vessels, injection of local anesthetic is performed in the circumferential diffusion space (like a small pocket) without redirecting needle.
The influence of this hydro-dissection on the nerve block efficiency is unknown. The nerve block quality can be improved because the entire anesthetic is injected in contact with the nerve, but it can also be reduced due to the dilution of the local anesthetic by the glucose solution.
In this randomized study, the investigators test the hypothesis that hydro-dissection does not alter the nerve block onset time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nerve block | Active comparator | Procedure: median nerve blockmedian nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000) |
| median nerve block after hydro-dissection | Experimental | Procedure: median nerve block after hydro-dissectionmedian nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000) after hydro-dissection (glucose 5% solution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with an ASA physical status I-II scheduled for elective ambulatory surgery of the hand or wrist involving the median nerve
Key exclusion criteria (5 listed)
- Patients with type 1 or 2 diabetes mellitus,
- History of clinical or laboratory evidence of abnormal bleeding,
- Infection at the injection site,
- Allergy to local anesthetic,
- Preexisting central or peripheral muscular or neurological disease (for example: carpal tunnel syndrome)
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 |
|---|---|---|
| median nerve blockmedian nerve block performed using ultrasound guidance | Procedure or surgery | nerve block |
| median nerve block after hydro-dissectionmedian nerve block performed after hydro-dissection (glucose 5% solution), both using ultrasound guidance | Procedure or surgery | median nerve block after hydro-dissection |
Primary outcome
Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)
Time frame: 30 minutes after injection
8 secondary outcomes
Onset time of sensory blockade (cold test at index finger and thenar eminence)
Time frame: 30 minutes after injection
Onset time (light touch test at thenar eminence)
Time frame: 30 minutes after injection
Onset time for motor blockade
Time frame: 30 minutes after injection
Success rate (% of patients with total light touch block at index finger within 30 min evaluation period)
Time frame: 30 minutes after injection
Successful surgical anesthesia
Time frame: 30 minutes after injection
Duration of nerve blockade
Time frame: 12 hours
Nerve block complication
Time frame: one month
Duration of the puncture procedure
Time frame: 30 minutes after the beginning of the procedure
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 23 Sep 2016.
- Derived from this study: PubMed 22745114Dufour E, Donat N, Jaziri S, Kurdi O, Couturier C, Dreyfus JF, Fischler M. Ultrasound-guided perineural circumferential median nerve block with and without prior dextrose 5% hydrodissection: a prospective randomized double-blinded noninferiority trial. Anesth Analg. 2012 Sep;115(3):728-33. doi: 10.1213/ANE.0b013e31825fa37d. Epub 2012 Jun 28.
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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
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing median nerve block and median nerve block after hydro-dissection in people with Nerve Block, run by Hopital Foch 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 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 23 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index) (time frame: 30 minutes after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058525, which also lists 1 linked publication.
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 23 Sep 2016.