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This is a Biomedical Research, prospective, randomized, double blind, controlled monocentric, phase IV comparison of the effects of two local anesthetics intrathecally: 0.5% levobupivacaine and ropivacaine 0.5%.
Progress in the practice of anesthesia led to a safety requirement of growing in daily practice. Spinal anesthesia commonly used technique for surgery of the lower limbs, provides a triple neurological lock (sensory, motor and autonomic) of roots of the spinal cord by intrathecal injection of a local anesthetic agent, following the rules of and strict aseptic conditions.
Levobupivacaine and ropivacaine local anesthetic agents are considered less toxic and tend to replace the use of bupivacaine, reference molecule, but the plasma transition is extremely toxic to patients. However, there is currently no study comparing the benefits of levobupivacaine and ropivacaine in isobaric form injected intrathecally for trauma surgery of the lower limbs. We propose to conduct a prospective, randomized double-blind comparison of the use of these two molecules in spinal isobaric form by evaluating the time and duration of action (sensory and motor block), hemodynamic and ventilatory changes (sympathetic block), and the occurrence of any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaïne 0,5%, | Active Comparator | intrathecal administration of 15mg of ropivacaine 0.5%. |
|
| lévobupivacaïne 0,5% | Active Comparator | intrathecal administration of 15mg of levobupivacaine 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ropivacaïne | Drug | spinal anesthesia. |
| |
| lévobupivacaïne |
| Measure | Description | Time Frame |
|---|---|---|
| duration of anesthesia on sensitivity | Thermo-algesic exploration of sensitivity through the application of an ice cube | during 6h after induction |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of anesthesia on motor block | during 6h after induction |
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Inclusion Criteria:
Exclusion Criteria:
Refusal of patients to participate in the study,
Patient with cons-indication to spinal anesthesia:
Patient trust,
Patients whose coagulation is abnormal.
Patients with cognitive impairment or incapacitated adult,
Multiple trauma,
Porphyria,
Central preexisting neuropathy,
A history of spinal surgery,
Epilepsy uncontrolled by treatment,
Hypovolemia,
Pregnant or lactating women,
Participation in another ongoing clinical trial,
Patient on anticoagulant therapy,
Patient not affiliated with a social security system.
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| Name | Affiliation | Role |
|---|---|---|
| Hervé DUPONT, Professor | CHU Amiens France | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hervé DUPONT | Amiens | Picardie | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | https://www.em-consulte.com/article/998410/comparaison-de-l-efficacite-de-la-levobupivacaine- |
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| Drug |
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