Coronary Artery BypassPhase 4NCT00552864
Comparison of Ropivacaine and Levobupivacaine in High Thoracic Epidural Anesthesia
A Phase 4 study testing Ropivacaine and Levobupivacaine in people with Coronary Artery Bypass and Epidural Anesthesia, run by Centro Cardiologico Monzino at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass, Epidural Anesthesia
- What is being tested?
- Ropivacaine and Levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2003to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino
Milan, 20138
About this study
Official title: High Thoracic Epidural Anesthesia and Postoperative Analgesia With Ropivacaine or Levobupivacaine for Coronary Surgery: A Prospective Randomized Double-Blind Comparison
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.
Read the 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.
- Conditions
- Coronary Artery Bypass, Epidural Anesthesia
- Being tested
- Ropivacaine, Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropina
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.
LevobupivacaineDrug
Also called Chirocaina
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.
| Study group | Role | What they receive |
|---|---|---|
| R | Active comparator | Not described Receives: Drug: Ropivacaine |
| L | Active comparator | Not described Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of local anesthetic drug (mg) required to maintain a visual analog scale score for pain (VAS) < 4 when coughing.
Measured: 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.
Measured: The first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2007 (estimated)
- Study startJan 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiologico Monzino
- Sponsor type
- University, hospital or other
- Investigators
- Luca Salvi, MD, Principal investigator, Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552864
- Sponsor's protocol ID
- CCMAneste001
- Status last verified
- Oct 2007
- First submitted
- 31 Oct 2007
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16183682Casati 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.
PubMed 15966496
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Thoracic Epidural Anesthesia and Postoperative Analgesia With Ropivacaine or Levobupivacaine for Coronary Surgery: A Prospective Randomized Double-Blind Comparison
- ClinicalTrials.gov ID
- NCT00552864
- Acronym / sponsor ID
- CCMAneste001
- Conditions
- Coronary Artery Bypass, Epidural Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centro Cardiologico MonzinoUniversity, hospital or other
- Study start
- Jan 2003
- Study completion
- Jun 2005 (actual)
- First posted
- 2 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R | Active comparator | Drug: Ropivacaine |
| L | Active comparator | Drug: Levobupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled for coronary artery bypass grafting
- with stable angina
- left ventricular ejection fraction > 30%
- age > 18 years
- having signed a written informed consent.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: Naropina0.5% 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. | Drug | R |
| LevobupivacaineAlso: Chirocaina0.5% 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. | Drug | L |
Primary outcome
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
1 secondary outcome
- 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Background: PubMed 16183682Olivier 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.
- Background: PubMed 15966496Casati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Salvi, MD principal investigator
Department of Anesthesia & ICU. IRCCS Centro Cardiologico Monzino.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Levobupivacaine in people with Coronary Artery Bypass and Epidural Anesthesia, run by Centro Cardiologico Monzino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00552864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2007.