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CompletedNCT01058525Hydro-EchoUpdated Sep 23, 2016

Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency

A Phase 4 interventional study of median nerve block and median nerve block after hydro-dissection in Nerve Block, sponsored by Hopital Foch. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by Hopital Foch · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Nerve Block
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In context

Lead sponsor

Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients with an ASA physical status I-II scheduled for elective ambulatory surgery of the hand or wrist involving the median nerve

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    nerve block

    median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000)

    Procedure: median nerve block

  • Experimental
    median nerve block after hydro-dissection

    median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000) after hydro-dissection (glucose 5% solution)

    Procedure: median nerve block after hydro-dissection

Interventions

  • Proceduremedian nerve block

    median nerve block performed using ultrasound guidance

  • Proceduremedian nerve block after hydro-dissection

    median nerve block performed after hydro-dissection (glucose 5% solution), both using ultrasound guidance

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Onset time of sensory blockade (cold test at index finger and thenar eminence)

    Time frame: 30 minutes after injection

  2. Onset time (light touch test at thenar eminence)

    Time frame: 30 minutes after injection

  3. Onset time for motor blockade

    Time frame: 30 minutes after injection

  4. Success rate (% of patients with total light touch block at index finger within 30 min evaluation period)

    Time frame: 30 minutes after injection

  5. Successful surgical anesthesia

    Time frame: 30 minutes after injection

  6. Duration of nerve blockade

    Time frame: 12 hours

  7. Nerve block complication

    Time frame: one month

  8. Duration of the puncture procedure

    Time frame: 30 minutes after the beginning of the procedure

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Study locations

1 site
  • Hôpital Privé de l'Ouest Parisien
    Trappes, 78190, France
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01058525
Lead sponsor
Hopital Foch
Responsible party
Sponsor
First posted
Jan 28, 2010
Start date
Jan 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Sep 23, 2016

Study contacts

Marc Fischler
study chair · Hôpital Foch

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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