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

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.

Study Overview

• Status: Unknown
• Conditions: Anesthetics, Local; Anesthesia Conduction; Injuries, Hand
• Intervention / Treatment: Drug: Bupivacaine; Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B; Arm number B corresponds to the Bupivacaine group.	Drug: Bupivacaine; Dosage: 150mg at once for anesthesia induction
Active Comparator: R; Arm number R corresponds to the Ropivacaine group.	Drug: Ropivacaine; Single dose of ropivacaine, 150mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular safety	Two days

Secondary Outcome Measures

Outcome Measure	Time Frame
Anesthesia Analgesia quality	Two days

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: 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

Publications and helpful links

General Publications

• 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. doi: 10.1097/00000539-200301000-00051.
• 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. doi: 10.1016/s0952-8180(02)00513-5.
• 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. doi: 10.1016/s0952-8180(01)00364-6.
• 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. doi: 10.1016/j.rapm.2004.09.005.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): March 1, 2009
• Study Completion (Anticipated): July 1, 2009

Study Registration Dates

• First Submitted: August 29, 2007
• First Submitted That Met QC Criteria: August 29, 2007
• First Posted (Estimate): August 31, 2007

Study Record Updates

• Last Update Posted (Estimate): February 19, 2009
• Last Update Submitted That Met QC Criteria: February 18, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Upper Extremity; Local anesthetic; Bupivacaine; Ropivacaine
• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: CRT029