Overview

This trial is active, not recruiting.

Conditions injuries, hand, anesthesia conduction, anesthetics, local
Treatments bupivacaine, ropivacaine
Phase phase 4
Sponsor University of Sao Paulo
Collaborator Cristália Produtos Químicos Farmacêuticos Ltda.
Start date October 2007
End date March 2009
Trial size 48 participants
Trial identifier NCT00523289, CRT029

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Arm
(Active Comparator)
Arm number B corresponds to the Bupivacaine group.
bupivacaine
Dosage: 150mg at once for anesthesia induction
(Active Comparator)
Arm number R corresponds to the Ropivacaine group.
ropivacaine
Single dose of ropivacaine, 150mg

Primary Outcomes

Measure
Cardiovascular safety
time frame: Two days

Secondary Outcomes

Measure
Anesthesia Analgesia quality
time frame: Two days

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo.