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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|