Trial | NCT00523289  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    48
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.
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 Started
Oct 31
2007
Primary Completion
Mar 31
2009
Anticipated
Study Completion
Jul 31
2009
Anticipated
Last Update
Feb 19
2009
Estimate

Drug Bupivacaine

Dosage: 150mg at once for anesthesia induction

Drug Ropivacaine

Single dose of ropivacaine, 150mg

B Active Comparator

Arm number B corresponds to the Bupivacaine group.

R Active Comparator

Arm number R corresponds to the Ropivacaine group.

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.
No Results Posted