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Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block
This study has been completed.
Study NCT00567450   Information provided by Centre Hospitalier Universitaire, Amiens
First Received: December 4, 2007   Last Updated: January 27, 2009   History of Changes

December 4, 2007
January 27, 2009
September 2007
September 2008   (final data collection date for primary outcome measure)
Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve [ Time Frame: 4h ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00567450 on ClinicalTrials.gov Archive Site
intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, and its side effects. [ Time Frame: 48h ] [ Designated as safety issue: Yes ]
Same as current
 
Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block
Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study

In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.

This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Efficacy Study
Subgluteal Sciatic Block
  • Drug: ropivacaine
  • Drug: ropivacaine plus mepivacaine
  • Active Comparator: 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
  • Experimental: 30 ml of ropivacaine 0.75%
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age > 18 years
  • surgery of the foot under sciatic block

Exclusion Criteria:

  • no indication of locoregional anesthesia
  • polyneuropathy or any neurological disease
  • know hypersensitivity to local anesthetics
  • porphyria
  • atrio-ventricular block
  • not controlled epilepsia
  • hypovolemia
  • pregnancy
  • anticoagulant treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00567450
Prof Herve Dupont, Anesthesiology and Critical Care Department
2007-002254-31, EudraCT: 2007-002254-31, AFFSAPS: A70388-33
Centre Hospitalier Universitaire, Amiens
 
Principal Investigator: Campana Philippe, MD Anesthesiology department
Centre Hospitalier Universitaire, Amiens
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP