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

Phase 4

Terminated

• Conditions: Nerve Block
• Interventions: Drug: levobupivacaïne 0,5 %; Drug: ropivacaïne 0,5 %

• Registration Number: NCT00956709
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2014-07-07
• Results First Submitted QC: 2014-07-07
• Results First Posted: 2014-08-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaïne 0,5 %	levobupivacaïne 0,5 %	-
Ropivacaïne 0,5%	ropivacaïne 0,5 %	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France