Patients Undergoing Lower Limb Surgery
Conditions
Keywords
Anesthesia, Randomized study, Lower limbs surgery
Brief summary
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%.
Detailed description
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.
Interventions
DRUGropivacaïne
spinal anesthesia.
DRUGlévobupivacaïne
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patient admitted to the emergency for lower limb trauma, * age over 18 years and below 65 years * lower limb trauma surgery can be performed under spinal anesthesia.
Exclusion criteria
* Refusal of patients to participate in the study, * Patient with cons-indication to spinal anesthesia: * Local anesthetic allergy agents (1/13000) * bleeding disorders, including pharmacological origin * infection at the puncture site, * refusal of spinal anesthesia by the patient, * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of anesthesia on sensitivity | during 6h after induction | Thermo-algesic exploration of sensitivity through the application of an ice cube |
Secondary
| Measure | Time frame |
|---|---|
| Duration of anesthesia on motor block | during 6h after induction |
Countries
France
Outcome results
None listed