Clinical Trials Directory

Trials / Terminated

TerminatedNCT00956709

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

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Nantes University Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGlevobupivacaïne 0,5 %20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
DRUGropivacaïne 0,5 %20mL de ropivacaïne 0,5 %

Timeline

Start date
2008-12-01
Primary completion
2011-11-01
Completion
2011-11-01
First posted
2009-08-11
Last updated
2016-10-05
Results posted
2014-08-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00956709. Inclusion in this directory is not an endorsement.

Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Thr (NCT00956709) · Clinical Trials Directory