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Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block

This study is not yet open for participant recruitment.
Verified by University of Sao Paulo, August 2007

Sponsors and Collaborators: University of Sao Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by: University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00523289
  Purpose

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
Injuries, Hand
Anesthesia Conduction
Anesthetics, Local
Drug: Bupivacaine
Phase IV

MedlinePlus related topics:   Anesthesia   

ChemIDplus related topics:   Ropivacaine    Ropivacaine Hydrochloride    Ropivacaine monohydrochloride    Bupivacaine    Bupivacaine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Cardiovascular safety [ Time Frame: Two days ]

Secondary Outcome Measures:
  • Anesthesia Analgesia quality [ Time Frame: Two days ]

Estimated Enrollment:   48
Study Start Date:   October 2007
Estimated Study Completion Date:   March 2008

Intervention Details:
    Drug: Bupivacaine
    Dosage: 150mg at once for anesthesia induction
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.

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Patients involved: 48; ASA I and II;
  • Surgery: elective upper extremity orthopedic surgery.

Exclusion Criteria:

  • Contraindications to anesthesia technique and/or to local anesthetic;
  • Participation in different trials in the last two months
  • Antiretroviral users;
  • Obesity.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523289

Contacts
Contact: José Otávio C Auler Junior, PhD/Chairman     55-11-3069-5232     auler@hcnet.usp.br    

Sponsors and Collaborators
University of Sao Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.

Investigators
Study Chair:     José Otávio C Auler Junior, PhD/Chairman     Hospital da Clínicas - Medicine School of the University of São Paulo    
  More Information

Publications:

Study ID Numbers:   CRT029
First Received:   August 29, 2007
Last Updated:   August 31, 2007
ClinicalTrials.gov Identifier:   NCT00523289
Health Authority:   Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Ropivacaine  
Bupivacaine  
Upper Extremity  
Local anesthetic  

Study placed in the following topic categories:
Ropivacaine
Wounds and Injuries
Disorders of Environmental Origin
Bupivacaine
Hand Injuries

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on August 29, 2008




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