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

NCT ID: NCT01058525

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

nerve block

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

Group Type: ACTIVE_COMPARATOR

median nerve block

Intervention Type: PROCEDURE

median nerve block performed using ultrasound guidance

median nerve block after hydro-dissection

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

Group Type: EXPERIMENTAL

median nerve block after hydro-dissection

Intervention Type: PROCEDURE

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

Interventions

median nerve block

median nerve block performed using ultrasound guidance

Intervention Type: PROCEDURE

median nerve block after hydro-dissection

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital Foch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Fischler

Role: STUDY_CHAIR

Hôpital Foch

Locations

Hôpital Privé de l'Ouest Parisien

Trappes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 22745114 (View on PubMed)

Other Identifiers

2009/27

Identifier Type: -

Identifier Source: org_study_id