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

University of Sao Paulo

Status and phase: Unknown; Phase 4

Conditions: Anesthetics, Local; Anesthesia Conduction; Injuries, Hand

Treatments: Drug: Bupivacaine; Drug: Ropivacaine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00523289

CRT029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

48 participants in 2 patient groups

B

Active Comparator group

Description:

Arm number B corresponds to the Bupivacaine group.

Treatment:

Drug: Bupivacaine

R

Active Comparator group

Description:

Arm number R corresponds to the Ropivacaine group.

Treatment:

Drug: Ropivacaine