Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block - Full Text View

Sponsors and Collaborators:	University of Sao Paulo Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00523289

Purpose

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.

Condition	Intervention	Phase
Injuries, Hand Anesthesia Conduction Anesthetics, Local	Drug: Bupivacaine	Phase IV

MedlinePlus related topics: Anesthesia

Drug Information available for: Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Cardiovascular safety [ Time Frame: Two days ]

Secondary Outcome Measures:

Anesthesia Analgesia quality [ Time Frame: Two days ]

Estimated Enrollment:	48
Study Start Date:	October 2007
Estimated Study Completion Date:	March 2008

Intervention Details:

Dosage: 150mg at once for anesthesia induction

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523289

Contacts

Contact: José Otávio C Auler Junior, PhD/Chairman

55-11-3069-5232

auler@hcnet.usp.br

Sponsors and Collaborators

University of Sao Paulo

Cristália Produtos Químicos Farmacêuticos Ltda.

Investigators

Study Chair:

José Otávio C Auler Junior, PhD/Chairman

Hospital da Clínicas - Medicine School of the University of São Paulo

More Information

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.

Study ID Numbers:	CRT029
Study First Received:	August 29, 2007
Last Updated:	August 31, 2007
ClinicalTrials.gov Identifier:	NCT00523289
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:

Ropivacaine
Bupivacaine
Upper Extremity
Local anesthetic

Study placed in the following topic categories:

Ropivacaine
Wounds and Injuries
Disorders of Environmental Origin
Bupivacaine
Hand Injuries

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009