Nerve Block
Conditions
Brief summary
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.
Interventions
DRUGlevobupivacaïne 0,5 %
20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
DRUGropivacaïne 0,5 %
20mL de ropivacaïne 0,5 %
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Exclusion criteria
* Diabetes * Intoxication-alcoholic chronic * Allergy to local anesthetics * Hemostasis disorders * Hepatic failure * Chronic pain syndrome
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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) | 72 hours |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Levobupivacaïne 0,5 % levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 % | 16 |
| Ropivacaïne 0,5% ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 % | 19 |
| Total | 35 |
Baseline characteristics
| Characteristic | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 15 Participants | 25 Participants |
| Age, Continuous | 62 years | 62 years | 62 years |
| Region of Enrollment France | 16 participants | 19 participants | 35 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 19 |
| serious Total, serious adverse events | 0 / 16 | 0 / 19 |
Outcome results
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
Time frame: 72 hours
Population: Two patients in each group had incomplete block before surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levobupivacaïne 0,5 % | Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot | 40 minutes |
| Ropivacaïne 0,5% | Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot | 35 minutes |
p-value: 0.56Wilcoxon (Mann-Whitney)
Secondary
Duration of Motor Sciatic Block (h)
Time frame: 72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levobupivacaïne 0,5 % | Duration of Motor Sciatic Block (h) | 15.54 hours |
| Ropivacaïne 0,5% | Duration of Motor Sciatic Block (h) | 15.17 hours |
p-value: 0.3354Wilcoxon (Mann-Whitney)
Secondary
Duration of Sensory Sciatic Block (h)
Time frame: 72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Levobupivacaïne 0,5 % | Duration of Sensory Sciatic Block (h) | 17.25 hours |
| Ropivacaïne 0,5% | Duration of Sensory Sciatic Block (h) | 15.00 hours |
p-value: 0.0445Wilcoxon (Mann-Whitney)
Secondary
Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.
Time frame: 72 hours