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Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block
This study is ongoing, but not recruiting participants.
Study NCT00523289   Information provided by University of Sao Paulo
First Received: August 29, 2007   Last Updated: February 18, 2009   History of Changes

August 29, 2007
February 18, 2009
October 2007
March 2009   (final data collection date for primary outcome measure)
Cardiovascular safety [ Time Frame: Two days ] [ Designated as safety issue: Yes ]
Cardiovascular safety [ Time Frame: Two days ]
Complete list of historical versions of study NCT00523289 on ClinicalTrials.gov Archive Site
Anesthesia Analgesia quality [ Time Frame: Two days ] [ Designated as safety issue: Yes ]
Anesthesia Analgesia quality [ Time Frame: Two days ]
 
Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block
 

The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25% racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial plexus block for orthopedic surgery.

The intoxication by Bupivacaine is considered life threatening. Currently the most safety local anesthetic in substitution to bupivacaine is ropivacaine, however in Brasil there is a bupivacaine mixture of 75% levobupivacaine plus 25% racemic bupivacaine. The research design is:

Patients involved: 48; age: 18 to 40 years old; both sex; ASA I and II. Surgery: elective upper extremity orthopedic surgery. Anesthesia technique: brachial plexus block. Primary endpoint: cardiovascular safety; analysis by continuous Holter. Secondary endpoint: anesthetic and analgesic efficacy.

Phase IV
Interventional
Other, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
  • Injuries, Hand
  • Anesthesia Conduction
  • Anesthetics, Local
  • Drug: Bupivacaine
  • Drug: Ropivacaine
  • Active Comparator: Arm number B corresponds to the Bupivacaine group.
  • Active Comparator: Arm number R corresponds to the Ropivacaine group.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
48
July 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients involved: 48; ASA I and II;
  • Surgery: elective upper extremity orthopedic surgery.

Exclusion Criteria:

  • Contraindications to anesthesia technique and/or to local anesthetic;
  • Participation in different trials in the last two months;
  • Antiretroviral users;
  • Obesity.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00523289
José O.Costa Auler Jr - Full prof.Anesthesiology USP, University Sao Paulo
CRT029
University of Sao Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
Study Chair: José Otávio C Auler Junior, PhD/Chairman Hospital das Clínicas - Medicine School of the University of São Paulo
University of Sao Paulo
February 2009

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