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| Tracking Information | |||||
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| First Received Date ICMJE | August 29, 2007 | ||||
| Last Updated Date | February 18, 2009 | ||||
| Start Date ICMJE | October 2007 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Cardiovascular safety [ Time Frame: Two days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Cardiovascular safety [ Time Frame: Two days ] | ||||
| Change History | Complete list of historical versions of study NCT00523289 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Anesthesia Analgesia quality [ Time Frame: Two days ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Anesthesia Analgesia quality [ Time Frame: Two days ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block | ||||
| Official Title ICMJE | |||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Other, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 40 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00523289 | ||||
| Responsible Party | José O.Costa Auler Jr - Full prof.Anesthesiology USP, University Sao Paulo | ||||
| Study ID Numbers ICMJE | CRT029 | ||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||
| Collaborators ICMJE | Cristália Produtos Químicos Farmacêuticos Ltda. | ||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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