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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by:
University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Injuries, Hand Anesthesia Conduction Anesthetics, Local Drug: Bupivacaine Drug: Ropivacaine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: B
Arm number B corresponds to the Bupivacaine group.
Drug: Bupivacaine
Dosage: 150mg at once for anesthesia induction
Active Comparator: R
Arm number R corresponds to the Ropivacaine group.
Drug: Ropivacaine
Single dose of ropivacaine, 150mg

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00523289

Sponsors and Collaborators
University of Sao Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
Study Chair: José Otávio C Auler Junior, PhD/Chairman Hospital das Clínicas - Medicine School of the University of São Paulo

Responsible Party: José O.Costa Auler Jr - Full prof.Anesthesiology USP, University Sao Paulo Identifier: NCT00523289     History of Changes
Other Study ID Numbers: CRT029
First Posted: August 31, 2007    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009

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

Additional relevant MeSH terms:
Hand Injuries
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents