Skip to main content
Clinical Trials/NCT00956709
NCT00956709
Terminated
Phase 4

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

Nantes University Hospital1 site in 1 country35 target enrollmentDecember 2008

Overview

Phase
Phase 4
Intervention
ropivacaïne 0,5 %
Conditions
Nerve Block
Sponsor
Nantes University Hospital
Enrollment
35
Locations
1
Primary Endpoint
Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
November 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

  • Intoxication-alcoholic chronic
  • Allergy to local anesthetics
  • Hemostasis disorders
  • Hepatic failure
  • Chronic pain syndrome

Arms & Interventions

Ropivacaïne 0,5%

Intervention: ropivacaïne 0,5 %

Levobupivacaïne 0,5 %

Intervention: levobupivacaïne 0,5 %

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials