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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivacaïne 0,5 % | Active Comparator |
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| Ropivacaïne 0,5% | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levobupivacaïne 0,5 % | Drug | 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 % |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve. | 72 hours | |
| Duration of Motor Sciatic Block (h) | 72 hours | |
| Duration of Sensory Sciatic Block (h) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | 44093 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levobupivacaïne 0,5 % | levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 % |
| FG001 | Ropivacaïne 0,5% | ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 % |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ropivacaïne 0,5 % | Drug | 20mL de ropivacaïne 0,5 % |
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| 72 hours |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levobupivacaïne 0,5 % | levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 % |
| BG001 | Ropivacaïne 0,5% | ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 % |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot | Two patients in each group had incomplete block before surgery. | Posted | Median | Full Range | minutes | 72 hours |
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| Secondary | Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve. | Not Posted | 72 hours | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Motor Sciatic Block (h) | Posted | Median | Full Range | hours | 72 hours |
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| Secondary | Duration of Sensory Sciatic Block (h) | Posted | Median | Full Range | hours | 72 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levobupivacaïne 0,5 % | levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 % | 0 | 16 | 0 | 16 | ||
| EG001 | Ropivacaïne 0,5% | ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 % | 0 | 19 | 0 | 19 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pham Dang | CHU de Nantes | 33 2 53 48 24 15 | charles.phamdang@chu-nantes.fr |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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