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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Injuries, Hand Anesthesia Conduction Anesthetics, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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B

Arm number B corresponds to the Bupivacaine group.

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Dosage: 150mg at once for anesthesia induction

R

Arm number R corresponds to the Ropivacaine group.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Single dose of ropivacaine, 150mg

Interventions

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Bupivacaine

Dosage: 150mg at once for anesthesia induction

Intervention Type DRUG

Ropivacaine

Single dose of ropivacaine, 150mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes