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

Anesthetics, Local Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00523289
• Other study ID #: CRT029
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 29, 2007
• Last updated: February 18, 2009
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: February 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: July 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Anesthesia Conduction
• Anesthetics, Local
• Injuries, Hand

Intervention

Drug:
• Bupivacaine
Dosage: 150mg at once for anesthesia induction
• Ropivacaine
Single dose of ropivacaine, 150mg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Cristália Produtos Químicos Farmacêuticos Ltda.

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular safety		Two days	Yes
Secondary	Anesthesia Analgesia quality		Two days	Yes