Comparison of Ropivacaine and Levobupivacaine in High Thoracic Epidural Anesthesia

NCT00552864 | Completed Phase 4

• 1 other identifier: CCMAneste001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

In High Thoracic Epidural Anesthesia (HTEA) the use of a local anesthetic (LA) with low cardiac toxicity is crucial as myocardial contractility is often already seriously impaired. The aim of this study is to compare the efficacy, doses and side effects of ropivacaine and levobupivacaine in patients submitted to coronary artery bypass graft with HTEA and general anesthesia. The primary end point is the amount of LA drug required to maintain a VAS \< 4 when coughing in the first 24 postoperative hours.

Conditions

Coronary Artery Bypass; Epidural Anesthesia

Outcome Measures

Primary Outcomes (1)

• The amount of local anesthetic drug (mg) required to maintain a visual analog scale score for pain (VAS) < 4 when coughing.

  the first 24 postoperative hours

Secondary Outcomes (1)

• - The onset time of a T1-T6 block after the bolus. - the amount of norepinephrine needed to maintain MAP > 70. - differences in motor block. - side effects.

  The first 24 postoperative hours

Study Arms (2)

R

ACTIVE COMPARATOR

Drug: Ropivacaine

L

ACTIVE COMPARATOR

Drug: Levobupivacaine

Interventions

Ropivacaine DRUG

0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.

Also known as: Naropina

R

Levobupivacaine DRUG

0.5% epidural bolus injection (0.1 mL kg-1) with sufentanil 2.5 µg mL-1 before general anesthesia induction, followed by 0.2% infusion (0.1 mL kg-1 h-1) with sufentanil 1 µg mL-1 throughout surgery; in ICU, 0.1% epidural infusion with sufentanil 1µg mL-1 at 0.1 mL kg-1 h-1 and the rate is modified following this protocol: on awakening (Ramsay 2) VAS on coughing is evaluated: if it is 4 the infusion rate is not changed, if the VAS is ≥ 4 the rate is increased by 2 mL h-1 after giving a 2 mL bolus and VAS is checked again 30 minutes later, if it is ≤ 4 the infusion rate is decreased by 2 mL h-1.

Also known as: Chirocaina

L

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for coronary artery bypass grafting
• with stable angina
• left ventricular ejection fraction \> 30%
• age \> 18 years
• having signed a written informed consent.
• Prothrombin Time (PT) \> 80% and Partial Thromboplastin Time (PTT) within the normal range, and platelet counts (PLT) \> 100.000 /mL

You may not qualify if:

• emergency operation
• known coagulation disorders or recent thrombolytic therapy
• angina on arrival in the operating room
• acute myocardial infarction within the previous seven days
• clinically significant associated valvular disease
• known neuraxial pathology
• patients participating in other clinical research protocols.

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead

Study Sites (1)

Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Related Publications (2)

• Olivier JF, Le N, Choiniere JL, Prieto I, Basile F, Hemmerling T. Comparison of three different epidural solutions in off-pump cardiac surgery: pilot study. Br J Anaesth. 2005 Nov;95(5):685-91. doi: 10.1093/bja/aei238. Epub 2005 Sep 23.

  PMID: 16183682 BACKGROUND

• Casati A, Putzu M. Bupivacaine, levobupivacaine and ropivacaine: are they clinically different? Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):247-68. doi: 10.1016/j.bpa.2004.12.003.

  PMID: 15966496 BACKGROUND

MeSH Terms

Interventions

Ropivacaine; Levobupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bupivacaine

Study Officials

• Luca Salvi, MD

  Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 31, 2007
• First Posted: November 2, 2007
• Study Start: January 1, 2003
• Study Completion: June 1, 2005
• Last Updated: November 2, 2007

Record last verified: 2007-10

Locations

IT (1)