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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00956709
First Posted: August 11, 2009
Last Update Posted: October 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
August 10, 2009
August 11, 2009
July 7, 2014
August 1, 2014
October 5, 2016
December 2008
November 2011   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00956709 on ClinicalTrials.gov Archive Site
  • Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve. [ Time Frame: 72 hours ]
  • Duration of Motor Sciatic Block (h) [ Time Frame: 72 hours ]
  • Duration of Sensory Sciatic Block (h) [ Time Frame: 72 hours ]
Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Nerve Block
  • Drug: levobupivacaïne 0,5 %
    20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
  • Drug: ropivacaïne 0,5 %
    20mL de ropivacaïne 0,5 %
  • Active Comparator: Levobupivacaïne 0,5 %
    Intervention: Drug: levobupivacaïne 0,5 %
  • Active Comparator: Ropivacaïne 0,5%
    Intervention: Drug: ropivacaïne 0,5 %
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
November 2011
November 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00956709
BRD/08/05-D
No
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP