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

• ClinicalTrials.gov Identifier: NCT00956709
• Recruitment Status: Terminated
• First Posted: August 11, 2009
• Results First Posted: August 1, 2014
• Last Update Posted: October 5, 2016
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Nantes University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Nerve Block	Drug: levobupivacaïne 0,5 %; Drug: ropivacaïne 0,5 %	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: December 2008
• Actual Primary Completion Date: November 2011
• Actual Study Completion Date: November 2011

Arms and Interventions

Arm	Intervention/treatment
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 %

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve. [ Time Frame: 72 hours ]
2. Duration of Motor Sciatic Block (h) [ Time Frame: 72 hours ]
3. Duration of Sensory Sciatic Block (h) [ Time Frame: 72 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Nantes University Hospital

Nantes, France, 44093

Sponsors and Collaborators

Nantes University Hospital

More Information

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT00956709
• Other Study ID Numbers: BRD/08/05-D
• First Posted: August 11, 2009
• Results First Posted: August 1, 2014
• Last Update Posted: October 5, 2016
• Last Verified: October 2016

Additional relevant MeSH terms:

Ropivacaine; Levobupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents