Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block
Recruitment status was: Active, not recruiting
|Injuries, Hand Anesthesia Conduction Anesthetics, Local||Drug: Bupivacaine Drug: Ropivacaine||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
- Cardiovascular safety [ Time Frame: Two days ]
- Anesthesia Analgesia quality [ Time Frame: Two days ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||July 2009|
|Estimated Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00523289
|Study Chair:||José Otávio C Auler Junior, PhD/Chairman||Hospital das Clínicas - Medicine School of the University of São Paulo|