Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study |
- Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve [ Time Frame: 4h ] [ Designated as safety issue: Yes ]
- 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, and its side effects. [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Active Comparator: B
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%
|
|
Experimental: A
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:
- age > 18 years
- surgery of the foot under sciatic block
Exclusion Criteria:
- no indication of locoregional anesthesia
- polyneuropathy or any neurological disease
- know hypersensitivity to local anesthetics
- porphyria
- atrio-ventricular block
- not controlled epilepsia
- hypovolemia
- pregnancy
- anticoagulant treatment
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
No publications provided
| Responsible Party: | Prof Herve Dupont, Anesthesiology and Critical Care Department |
| ClinicalTrials.gov Identifier: | NCT00567450 History of Changes |
| Other Study ID Numbers: | 2007-002254-31, EudraCT: 2007-002254-31, AFFSAPS: A70388-33 |
| Study First Received: | December 4, 2007 |
| Last Updated: | January 27, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire, Amiens:
|
sciatic block ropivacaine mepivacaine locoregional anesthesia |
Additional relevant MeSH terms:
|
Mepivacaine Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013