Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block
Information source: University of Sao Paulo
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Injuries, Hand; Anesthesia Conduction; Anesthetics, Local
Intervention: Bupivacaine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s):
José Otávio C Auler Junior, PhD/Chairman, Study Chair, Affiliation: Hospital da Clínicas - Medicine School of the University of São Paulo
Overall contact:
José Otávio C Auler Junior, PhD/Chairman, Phone: 55-11-3069-5232, Email: auler@hcnet.usp.br
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.
Clinical Details
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Cardiovascular safety
Secondary outcome: Anesthesia Analgesia quality
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Both.
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.
Locations and Contacts
José Otávio C Auler Junior, PhD/Chairman, Phone: 55-11-3069-5232, Email: auler@hcnet.usp.br Additional Information
Related publications: Casati A, Santorsola R, Aldegheri G, Ravasi F, Fanelli G, Berti M, Fraschini G, Torri G. Intraoperative epidural anesthesia and postoperative analgesia with levobupivacaine for major orthopedic surgery: a double-blind, randomized comparison of racemic bupivacaine and ropivacaine. J Clin Anesth. 2003 Mar;15(2):126-31. Casati A, Chelly JE, Cerchierini E, Santorsola R, Nobili F, Grispigni C, Di Benedetto P, Torri G. Clinical properties of levobupivacaine or racemic bupivacaine for sciatic nerve block. J Clin Anesth. 2002 Mar;14(2):111-4. Casati A, Borghi B, Fanelli G, Montone N, Rotini R, Fraschini G, Vinciguerra F, Torri G, Chelly J. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg. 2003 Jan;96(1):253-9, table of contents. Santorsola R, Casati A, Cerchierini E, Moizo E, Fanelli G. [Levobupivacaine for peripheral blocks of the lower limb: a clinical comparison with bupivacaine and ropivacaine] Minerva Anestesiol. 2001 Sep;67(9 Suppl 1):33-6. Italian. Borgeat A, Ekatodramis G, Blumenthal S. Interscalene brachial plexus anesthesia with ropivacaine 5 mg/mL and bupivacaine 5 mg/mL: effects on electrocardiogram. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):557-63.
Starting date: October 2007
Ending date: March 2008
Last updated: August 31, 2007
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