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

Sponsor:	University of Sao Paulo
Collaborator:	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 Drug: Ropivacaine	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia

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

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

Cardiovascular safety [ Time Frame: Two days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Anesthesia Analgesia quality [ Time Frame: Two days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	October 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator Arm number B corresponds to the Bupivacaine group.	Drug: Bupivacaine Dosage: 150mg at once for anesthesia induction
R: Active Comparator Arm number R corresponds to the Ropivacaine group.	Drug: Ropivacaine Single dose of ropivacaine, 150mg

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

Sponsors and Collaborators

University of Sao Paulo

Cristália Produtos Químicos Farmacêuticos Ltda.

Investigators

Study Chair:

José Otávio C Auler Junior, PhD/Chairman

Hospital das 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.

Responsible Party:	University Sao Paulo ( José O.Costa Auler Jr - Full prof.Anesthesiology USP )
Study ID Numbers:	CRT029
Study First Received:	August 29, 2007
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00523289 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:

Ropivacaine
Bupivacaine
Upper Extremity
Local anesthetic

Additional relevant MeSH terms:

Ropivacaine
Physiological Effects of Drugs
Wounds and Injuries
Disorders of Environmental Origin
Anesthetics
Central Nervous System Depressants
Hand Injuries

Anesthetics, Local
Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
Bupivacaine
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009