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

September 22, 2016 updated by: Hopital Foch

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Trappes, France, 78190
        • Hôpital Privé de l'Ouest Parisien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 2009/27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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