Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale

Nerve Block Clinical Trial

— SCIALERO  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00956709
• Other study ID #: BRD/08/05-D
• Status: Terminated
• Phase: Phase 4
• First received: August 10, 2009
• Last updated: October 3, 2016
• Start date: December 2008
• Est. completion date: November 2011

Study information

• Verified date: October 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Block

Intervention

Drug:
• levobupivacaïne 0,5 %
20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
• ropivacaïne 0,5 %
20mL de ropivacaïne 0,5 %

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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		72 hours	No
Secondary	Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.		72 hours	No
Secondary	Duration of Motor Sciatic Block (h)		72 hours	No
Secondary	Duration of Sensory Sciatic Block (h)		72 hours	No