Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block

Study Overview
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Brief Summary
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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.

Official Title
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Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study

Conditions
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Subgluteal Sciatic Block

Intervention / Treatment
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* Drug: ropivacaine
* Drug: ropivacaine plus mepivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% | Drug: ropivacaine plus mepivacaine<br>* 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%<br>|
| Experimental: A<br>30 ml of ropivacaine 0.75% | Drug: ropivacaine<br>* 30ml of a mixture of ropivacaïne 0.75%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve |  | 4h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 48h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sciatic block, ropivacaine, mepivacaine, locoregional anesthesia