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

October 3, 2016 updated by: Nantes University Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44093
        • Nantes university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Levobupivacaïne 0,5 %
Drug: levobupivacaïne 0,5 %
20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
Active Comparator: Ropivacaïne 0,5%
Drug: ropivacaïne 0,5 %
20mL de ropivacaïne 0,5 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.
Time Frame: 72 hours
72 hours
Duration of Motor Sciatic Block (h)
Time Frame: 72 hours
72 hours
Duration of Sensory Sciatic Block (h)
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 3, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/08/05-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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