Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale (SCIALERO)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Nerve Block |
Drug: levobupivacaïne 0,5 % Drug: ropivacaïne 0,5 % |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
- Compare the onset of action of ropivacaine 0.5% and 0.5% the levobupivacaïne for sciatic nerve block guided in major surgery of the foot [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Evaluate the relative position of the tibial and contigent fibulaire common in the sciatic nerve. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 35 |
| Study Start Date: | December 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Levobupivacaïne 0,5 % |
Drug: levobupivacaïne 0,5 %
20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
|
| Active Comparator: Ropivacaïne 0,5% |
Drug: ropivacaïne 0,5 %
20mL de ropivacaïne 0,5 %
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Nantes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00956709 History of Changes |
| Other Study ID Numbers: | BRD 08/5-D |
| Study First Received: | August 10, 2009 |
| Last Updated: | December 10, 2012 |
| Health Authority: | France: Ministry of Health |
Additional relevant MeSH terms:
|
Ropivacaine Levobupivacaine Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013