Ropivacaine Versus Ropivacaine Plus Mepivacaine for Sciatic Block

January 27, 2009 updated by: Centre Hospitalier Universitaire, Amiens

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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
      • Amiens cedex, France, 80054
        • CHU d'Amiens, Pole Anesthesie Réanimation, Place Victor Pauchet

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve
Time Frame: 4h
4h

Secondary Outcome Measures

Outcome Measure
Time Frame
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
48h

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Campana Philippe, MD, Anesthesiology Department

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

September 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-002254-31
  • EudraCT: 2007-002254-31
  • AFFSAPS: A70388-33

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.

Clinical Trials on Subgluteal Sciatic Block

Clinical Trials on ropivacaine plus mepivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe