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

NCT01058525 | Completed Phase 4

• 1 other identifier: 2009/27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nerve Block

Outcome Measures

Primary Outcomes (1)

• Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)

  30 minutes after injection

Secondary Outcomes (8)

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

  30 minutes after injection

• Onset time (light touch test at thenar eminence)

  30 minutes after injection

• Onset time for motor blockade

  30 minutes after injection

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

  30 minutes after injection

• Successful surgical anesthesia

  30 minutes after injection

Study Arms (2)

nerve block

ACTIVE COMPARATOR

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

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)

Procedure: median nerve block after hydro-dissection

Interventions

median nerve block PROCEDURE

median nerve block performed using ultrasound guidance

nerve block

median nerve block after hydro-dissection PROCEDURE

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

median nerve block after hydro-dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hôpital Privé de l'Ouest Parisien

Trappes, 78190, France

Location

Related Publications (1)

• 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.

  PMID: 22745114 DERIVED

Study Officials

• Marc Fischler

  Hôpital Foch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)