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| Sponsor: | Centre Hospitalier Universitaire, Amiens |
|---|---|
| Information provided by: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT00567450 |
Purpose
In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.
This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Subgluteal Sciatic Block |
Drug: ropivacaine Drug: ropivacaine plus mepivacaine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
B: Active Comparator
30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
|
Drug: ropivacaine plus mepivacaine
30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
|
|
A: Experimental
30 ml of ropivacaine 0.75%
|
Drug: ropivacaine
30ml of a mixture of ropivacaïne 0.75%
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| CHU d'Amiens, Pole Anesthesie Réanimation, Place Victor Pauchet | |
| Amiens cedex, France, 80054 | |
| Principal Investigator: | Campana Philippe, MD | Anesthesiology department |
More Information
| Responsible Party: | Anesthesiology and Critical Care Department ( Prof Herve Dupont ) |
| Study ID Numbers: | 2007-002254-31, EudraCT: 2007-002254-31, AFFSAPS: A70388-33 |
| Study First Received: | December 4, 2007 |
| Last Updated: | January 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00567450 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
sciatic block ropivacaine mepivacaine locoregional anesthesia |
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Mepivacaine Sensory System Agents Ropivacaine Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants |
Anesthetics Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |