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Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT00567450
First received: December 4, 2007
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Subgluteal Sciatic Block
Drug: ropivacaine
Drug: ropivacaine plus mepivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve [ Time Frame: 4h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: B
30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
Drug: ropivacaine plus mepivacaine
30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%
Experimental: A
30 ml of ropivacaine 0.75%
Drug: ropivacaine
30ml of a mixture of ropivacaïne 0.75%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567450

Locations
France
CHU d'Amiens, Pole Anesthesie Réanimation, Place Victor Pauchet
Amiens cedex, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Campana Philippe, MD Anesthesiology department
  More Information

No publications provided

Responsible Party: Prof Herve Dupont, Anesthesiology and Critical Care Department
ClinicalTrials.gov Identifier: NCT00567450     History of Changes
Other Study ID Numbers: 2007-002254-31, EudraCT: 2007-002254-31, AFFSAPS: A70388-33
Study First Received: December 4, 2007
Last Updated: January 27, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
sciatic block
ropivacaine
mepivacaine
locoregional anesthesia

Additional relevant MeSH terms:
Mepivacaine
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014