Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-09-30

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.

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Detailed Description

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Conditions

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Subgluteal Sciatic Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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B

30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%

Group Type ACTIVE_COMPARATOR

ropivacaine plus mepivacaine

Intervention Type DRUG

30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%

A

30 ml of ropivacaine 0.75%

Group Type EXPERIMENTAL

ropivacaine

Intervention Type DRUG

30ml of a mixture of ropivacaïne 0.75%

Interventions

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ropivacaine

30ml of a mixture of ropivacaïne 0.75%

Intervention Type DRUG

ropivacaine plus mepivacaine

30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No