Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

Study Overview
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Brief Summary
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The aim of the present study was to assess the efficacy of thoracic epidural anesthesia followed by postoperative epidural infusion and patient-controlled epidural analgesia with ropivacaine/fentanyl in off-pump coronary artery bypass grafting

Detailed Description
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Ninety-three patients were scheduled for off-pump coronary artery bypass (OPCAB) under propofol/fentanyl anesthesia. Day before surgery patients were asked for informed consent and randomized into three postoperative analgesia regimens aiming at a visual analog scale (VAS) score <30 mm at rest. The control group (n=31) received intravenous fentanyl 10 µg/ml postoperatively 3-8 mL/h. After placement of an epidural catheter at the level of Th2-Th4 before OPCAB, a thoracic epidural infusion (EI) group (n=31) received epidural anesthesia (EA) intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous EI of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively. The patient-controlled epidural analgesia (PCEA) group (n=31), in addition to EA and EI, received PCEA (ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min) postoperatively. Hemodynamics and blood gases were measured throughout 24 h after OPCAB.

Official Title
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Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: intravenous analgesia
* Procedure: epidural infusion
* Procedure: patient-controlled epidural analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presence of coronary artery disease ASA II-III elective off-pump coronary artery bypass Exclusion Criteria: age < 18 years severe valve dysfunction or peripheral vascular disease simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.) transfer to CPB during surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous analgesia<br>Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h. | Procedure: intravenous analgesia<br>* Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h<br>|
| Active Comparator: epiduaral infusion<br>Patients received epidural analgesia intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively. | Procedure: epidural infusion<br>* Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL<br>|
| Active Comparator: patient-controlled epidural analgesia<br>In addition to epidural anesthesia and epidural infusion, postoperatively patients received patient-controlled epidural analgesia with ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min. | Procedure: patient-controlled epidural analgesia<br>* Postoperative analgesia was performed by continuous epidural infusion of ropivacaine/fentanyl mixture combined with patient-controlled epidural analgesia with ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative mechanical ventilation | Duration of postoperative mechanical ventilation, hours | Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic stability | Hemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids | All period of operation and during 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Analgesia, OPCAB, PCEA