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Sponsors and Collaborators: |
University of Sao Paulo Cristália Produtos Químicos Farmacêuticos Ltda. |
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Information provided by: | University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT00523289 |
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.
Condition | Intervention | Phase |
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Injuries, Hand Anesthesia Conduction Anesthetics, Local |
Drug: Bupivacaine |
Phase IV |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 48 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | March 2008 |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: José Otávio C Auler Junior, PhD/Chairman | 55-11-3069-5232 | auler@hcnet.usp.br |
Study Chair: | José Otávio C Auler Junior, PhD/Chairman | Hospital da Clínicas - Medicine School of the University of São Paulo |
Study ID Numbers: | CRT029 |
Study First Received: | August 29, 2007 |
Last Updated: | August 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00523289 |
Health Authority: | Brazil: National Health Surveillance Agency |
Ropivacaine Bupivacaine Upper Extremity Local anesthetic |
Ropivacaine Wounds and Injuries Disorders of Environmental Origin Bupivacaine Hand Injuries |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Depressants Anesthetics |
Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |