Clinical trial NCT01058525: Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency
Official title: Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nerve Block
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)
timeFrame: 30 minutes after injection
Secondary outcomes:
measure: Onset time of sensory blockade (cold test at index finger and thenar eminence)
timeFrame: 30 minutes after injection
measure: Onset time (light touch test at thenar eminence)
timeFrame: 30 minutes after injection
measure: Onset time for motor blockade
timeFrame: 30 minutes after injection
measure: Success rate (% of patients with total light touch block at index finger within 30 min evaluation period)
timeFrame: 30 minutes after injection
measure: Successful surgical anesthesia
timeFrame: 30 minutes after injection
measure: Duration of nerve blockade
timeFrame: 12 hours
measure: Nerve block complication
timeFrame: one month
measure: Duration of the puncture procedure
timeFrame: 30 minutes after the beginning of the procedure
Other outcomes:
Locations:
city: Trappes
country: France
facility: Hôpital Privé de l'Ouest Parisien
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler
role: STUDY_CHAIR
References:
citation: 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.