Comparison of Ropivacaine and Levobupivacaine in High Thoracic Epidural Anesthesia

Coronary Artery Bypass Clinical Trial

Official title:

High Thoracic Epidural Anesthesia and Postoperative Analgesia With Ropivacaine or Levobupivacaine for Coronary Surgery: A Prospective Randomized Double-Blind Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552864
• Other study ID #: CCMAneste001
• Status: Completed
• Phase: Phase 4
• First received: October 31, 2007
• Last updated: October 31, 2007
• Start date: January 2003
• Est. completion date: June 2005

Study information

• Verified date: October 2007
• Source: Centro Cardiologico Monzino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

The use of high thoracic epidural, combined with general anesthesia (HTEA) in patients undergoing cardiac surgery has become increasing popular in recent years. In fact, this technique is potentially beneficial because of the attenuation of the stress response to surgery, the sympathetic tone reduction and the excellent postoperative analgesia.Patients submitted to coronary artery bypass graft will be randomly allocated to receive high epidural block with ropivacaine (R) or levobupivacaine (L), supplemented with sufentanil, during and after surgery. Postoperatively, the rate of epidural infusion will be modified to maintain a VAS score less than 4 in the thoracic area when coughing. VAS, total amount and rate of epidural drug infusion, MAP, total amount and rate of norepinephrine infusion and motor block will be recorded on arrival in the ICU, on awakening and after 4, 8, 12, 24 hours. Additionally, the onset time of the epidural sensory block, the time of awakening and the time on ventilator will be recorded as well as episodes of postoperative nausea and vomiting (PONV) and pruritus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass
• Epidural Anesthesia

Intervention

Drug:
• Ropivacaine
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.
• Levobupivacaine
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.

Locations

Country	Name	City	State
Italy	Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Casati A, Putzu M. Bupivacaine, levobupivacaine and ropivacaine: are they clinically different? Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):247-68. Review. — View Citation

Olivier JF, Le N, Choinière 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. Epub 2005 Sep 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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