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

Nerve Block Clinical Trial

— Hydro-Echo  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058525
• Other study ID #: 2009/27
• Status: Completed
• Phase: Phase 4
• First received: January 27, 2010
• Last updated: September 22, 2016
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Block

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Privé de l'Ouest Parisien	Trappes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)		30 minutes after injection	No
Secondary	Onset time of sensory blockade (cold test at index finger and thenar eminence)		30 minutes after injection	No
Secondary	Onset time (light touch test at thenar eminence)		30 minutes after injection	No
Secondary	Onset time for motor blockade		30 minutes after injection	No
Secondary	Success rate (% of patients with total light touch block at index finger within 30 min evaluation period)		30 minutes after injection	No
Secondary	Successful surgical anesthesia		30 minutes after injection	No
Secondary	Duration of nerve blockade		12 hours	No
Secondary	Nerve block complication		one month	Yes
Secondary	Duration of the puncture procedure		30 minutes after the beginning of the procedure	No