Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block
|ClinicalTrials.gov Identifier: NCT00523289|
Recruitment Status : Unknown
Verified February 2009 by University of Sao Paulo.
Recruitment status was: Active, not recruiting
First Posted : August 31, 2007
Last Update Posted : February 19, 2009
|Condition or disease||Intervention/treatment||Phase|
|Injuries, Hand Anesthesia Conduction Anesthetics, Local||Drug: Bupivacaine Drug: Ropivacaine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||March 2009|
|Estimated Study Completion Date :||July 2009|
Active Comparator: B
Arm number B corresponds to the Bupivacaine group.
Dosage: 150mg at once for anesthesia induction
Active Comparator: R
Arm number R corresponds to the Ropivacaine group.
Single dose of ropivacaine, 150mg
- Cardiovascular safety [ Time Frame: Two days ]
- Anesthesia Analgesia quality [ Time Frame: Two days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00523289
|Study Chair:||José Otávio C Auler Junior, PhD/Chairman||Hospital das Clínicas - Medicine School of the University of São Paulo|