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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

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.

Detailed Summary:

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.

Sponsor: University of Sao Paulo

Current Primary Outcome: Cardiovascular safety [ Time Frame: Two days ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: August 29, 2007
Date Started: October 2007
Date Completion: July 2009
Last Updated: February 18, 2009
Last Verified: February 2009