Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: intravenous analgesia; Procedure: epidural infusion; Procedure: patient-controlled epidural analgesia

• Registration Number: NCT01384175
• Lead Sponsor: Northern State Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Status Verified: 2011-06
• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Last Update Submitted: 2011-06-28
• Last Update Posted: 2011-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous analgesia	intravenous analgesia	Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.
epiduaral infusion	epidural infusion	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.
patient-controlled epidural analgesia	patient-controlled epidural analgesia	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.

Primary Outcome Measures

Name	Time	Method
Duration of postoperative mechanical ventilation	Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours	Duration of postoperative mechanical ventilation, hours

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stability	All period of operation and during 24 hours postoperatively	Hemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids

Trial Locations

Locations (1)

Dep. of Anesthesiology, Northern SMU; 🇷🇺 Arkhangelsk, Russian Federation