Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2011-11-30

Brief Summary

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Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve \[4\]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound \[58\] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic \[46, 47\].

The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.

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Detailed Description

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Conditions

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Nerve Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Levobupivacaïne 0,5 %

Group Type ACTIVE_COMPARATOR

levobupivacaïne 0,5 %

Intervention Type DRUG

20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %

Ropivacaïne 0,5%

Group Type ACTIVE_COMPARATOR

ropivacaïne 0,5 %

Intervention Type DRUG

20mL de ropivacaïne 0,5 %

Interventions

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levobupivacaïne 0,5 %

20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %

Intervention Type DRUG

ropivacaïne 0,5 %

20mL de ropivacaïne 0,5 %

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with unilateral major surgery of the foot: hallux valgus (not ambulatory), claw toes, fusion-Astragalo calcaneum, complex syntheses of tarsus-aged over 18 years .
* Male and female
* ASA 1 or 2
* Insured Social
* Informed Consent