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

Phase 4

• Conditions: Injuries, Hand; Anesthesia Conduction; Anesthetics, Local
• Interventions: Drug: Bupivacaine; Drug: Ropivacaine

• Registration Number: NCT00523289
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-29
• Study First Posted: 2007-08-31
• Study Start: 2007-10
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-18
• Last Update Posted: 2009-02-19
• Primary Completion: 2009-03
• Study Completion: 2009-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Bupivacaine	Arm number B corresponds to the Bupivacaine group.
R	Ropivacaine	Arm number R corresponds to the Ropivacaine group.

Primary Outcome Measures

Name	Time	Method
Cardiovascular safety	Two days

Secondary Outcome Measures

Name	Time	Method
Anesthesia Analgesia quality	Two days