A Phase 4 interventional study of levobupivacaïne 0,5 % and ropivacaïne 0,5 % in Nerve Block, sponsored by Nantes University Hospital. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by Nantes University Hospital · Phase 4, Interventional, and Treatment
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.
Nantes University Hospital is the lead sponsor of 837 studies on the registry; 196 are open to participants now.
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Drug: levobupivacaïne 0,5 %
Drug: ropivacaïne 0,5 %
20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
20mL de ropivacaïne 0,5 %
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
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
| Milestone | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% |
|---|---|---|
| Started | 16 | 19 |
| Completed | 16 | 19 |
| Not completed | 0 | 0 |
| minutes | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% |
|---|---|---|
| Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot | 40 (15 to 60) | 35 (10 to 60) |
Results for this outcome have not been posted.
| hours | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% |
|---|---|---|
| Duration of Motor Sciatic Block (h) | 15.54 (5.25 to 37.50) | 15.17 (4.42 to 20.50) |
| hours | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% |
|---|---|---|
| Duration of Sensory Sciatic Block (h) | 17.25 (6.25 to 53.50) | 15.00 (8.52 to 23.67) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levobupivacaïne 0,5 % | — | 0/16 (0%) | 0/16 (0%) |
| Ropivacaïne 0,5% | — | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% | Total |
|---|---|---|---|
| Median | 62 (36 to 83) | 62 (35 to 75) | 62 (35 to 83) |
| Age, Categorical(Participants) | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 15 | 25 |
| >=65 years | 6 | 4 | 10 |
| Sex: Female, Male(Participants) | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% | Total |
|---|---|---|---|
| Female | 12 | 15 | 27 |
| Male | 4 | 4 | 8 |
| Region of Enrollment(participants) | Levobupivacaïne 0,5 % | Ropivacaïne 0,5% | Total |
|---|---|---|---|
| France | 16 | 19 | 35 |
The record gives a start of Dec 2008, a primary completion of Nov 2011 and a completion of Nov 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 2 years 9 months after primary completion.
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This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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