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

This study has been completed.
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01058525
First received: January 27, 2010
Last updated: January 22, 2011
Last verified: January 2011

January 27, 2010
January 22, 2011
January 2010
January 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058525 on ClinicalTrials.gov Archive Site
  • Onset time of sensory blockade (cold test at index finger and thenar eminence) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Onset time (light touch test at thenar eminence) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Onset time for motor blockade [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Success rate (% of patients with total light touch block at index finger within 30 min evaluation period) [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Successful surgical anesthesia [ Time Frame: 30 minutes after injection ] [ Designated as safety issue: No ]
  • Duration of nerve blockade [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
  • Nerve block complication [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Duration of the puncture procedure [ Time Frame: 30 minutes after the beginning of the procedure ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nerve Block
  • Procedure: median nerve block
    median nerve block performed using ultrasound guidance
  • Procedure: median nerve block after hydro-dissection
    median nerve block performed after hydro-dissection (glucose 5% solution), both using ultrasound guidance
  • Active Comparator: nerve block
    median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000)
    Intervention: 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)
    Intervention: Procedure: median nerve block after hydro-dissection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2011
January 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01058525
2009/27
No
Marc Fischler, Professor, Hôpital Foch
Hopital Foch
Not Provided
Study Chair: Marc Fischler Hôpital Foch
Hopital Foch
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP