- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01058525
Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency (Hydro-Echo)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Trappes, France, 78190
- Hôpital Privé de l'Ouest Parisien
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: nerve block
median nerve block (6 ml lidocaine 1.5 % with adrenalin 1:200000)
|
median nerve block performed using ultrasound guidance
|
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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)
|
median nerve block performed after hydro-dissection (glucose 5% solution), both using ultrasound guidance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
30 minutes after injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Onset time of sensory blockade (cold test at index finger and thenar eminence)
Time Frame: 30 minutes after injection
|
30 minutes after injection
|
|
Onset time (light touch test at thenar eminence)
Time Frame: 30 minutes after injection
|
30 minutes after injection
|
|
Onset time for motor blockade
Time Frame: 30 minutes after injection
|
30 minutes after injection
|
|
Success rate (% of patients with total light touch block at index finger within 30 min evaluation period)
Time Frame: 30 minutes after injection
|
30 minutes after injection
|
|
Successful surgical anesthesia
Time Frame: 30 minutes after injection
|
30 minutes after injection
|
|
Duration of nerve blockade
Time Frame: 12 hours
|
12 hours
|
|
Nerve block complication
Time Frame: one month
|
one month
|
|
Duration of the puncture procedure
Time Frame: 30 minutes after the beginning of the procedure
|
30 minutes after the beginning of the procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2009/27
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