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

Phase 4

Completed

• Conditions: Nerve Block
• Interventions: Procedure: median nerve block after hydro-dissection; Procedure: median nerve block

• Registration Number: NCT01058525
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Onset time of sensory blockade (light touch test: total loss of sensation at the two distal phalanges of index)	30 minutes after injection

Secondary Outcome Measures

Name	Time	Method
Nerve block complication	one month
Duration of the puncture procedure	30 minutes after the beginning of the procedure
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
Duration of nerve blockade	12 hours
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

Trial Locations

Locations (1)

Hôpital Privé de l'Ouest Parisien; 🇫🇷 Trappes, France