Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency (Hydro-Echo)
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2010 | ||||
| Last Updated Date | January 22, 2011 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01058525 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Influence of Ultrasonographic Hydro-dissection With Glucose 5% on Nerve Block Efficiency | ||||
| Official Title ICMJE | Influence of Ultrasonographic Hydro-dissection With Glucose 5% Solution on Median Nerve Block Efficiency: a Prospective and Randomized Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Nerve Block | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Completion Date | January 2011 | ||||
| Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01058525 | ||||
| Other Study ID Numbers ICMJE | 2009/27 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Marc Fischler, Professor, Hôpital Foch | ||||
| Study Sponsor ICMJE | Hopital Foch | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hopital Foch | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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