Regional Anesthesia for Major Surgery of the Foot. Levobupivaca�ne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through m�diof�morale
Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nerve Block
Intervention: levobupivacaïne 0,5 % (Drug); ropivacaïne 0,5 % (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Nantes University Hospital
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot
Secondary outcome: Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.Duration of Motor Sciatic Block (h) Duration of Sensory Sciatic Block (h)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Nantes University Hospital, Nantes 44093, France
Additional Information
Starting date: December 2008
Last updated: August 1, 2014
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