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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00956709
Other study ID # BRD/08/05-D
Secondary ID
Status Terminated
Phase Phase 4
First received August 10, 2009
Last updated October 3, 2016
Start date December 2008
Est. completion date November 2011

Study information

Verified date October 2016
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 35
Est. completion date November 2011
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
levobupivacaïne 0,5 %
20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
ropivacaïne 0,5 %
20mL de ropivacaïne 0,5 %

Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot 72 hours No
Secondary Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve. 72 hours No
Secondary Duration of Motor Sciatic Block (h) 72 hours No
Secondary Duration of Sensory Sciatic Block (h) 72 hours No
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