Comparison of Ropivacaine and Levobupivacaine in High Thoracic Epidural Anesthesia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Bypass Epidural Anesthesia |
Drug: Ropivacaine Drug: Levobupivacaine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | High Thoracic Epidural Anesthesia and Postoperative Analgesia With Ropivacaine or Levobupivacaine for Coronary Surgery: A Prospective Randomized Double-Blind Comparison |
- The amount of local anesthetic drug (mg) required to maintain a visual analog scale score for pain (VAS) < 4 when coughing. [ Time Frame: the first 24 postoperative hours ]
- - 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. [ Time Frame: The first 24 postoperative hours ]
| Enrollment: | 61 |
| Study Start Date: | January 2003 |
| Study Completion Date: | June 2005 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: R |
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.
Other Name: Naropina
|
| Active Comparator: L |
Drug: 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.
Other Name: Chirocaina
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Italy | |
| Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino | |
| Milano, Italy, 20138 | |
| Principal Investigator: | Luca Salvi, MD | Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino. |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00552864 History of Changes |
| Other Study ID Numbers: | CCMAneste001 |
| Study First Received: | October 31, 2007 |
| Last Updated: | October 31, 2007 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Anesthetics Ropivacaine Levobupivacaine Bupivacaine Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Local Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013