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Completed

NCT Number: NCT01058525

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Privé de l'Ouest Parisien

Trappes, 78190, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Median Nerve Block

Procedure

median nerve block performed using ultrasound guidance

median nerve block after hydro-dissection

Procedure

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

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

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study

Acronym: Hydro-Echo

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 28, 2010
Registry last updated
Sep 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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