Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384175
• Other study ID #: OPCAB-EA
• Status: Completed
• Phase: N/A
• First received: June 17, 2011
• Last updated: June 28, 2011
• Start date: January 2008
• Est. completion date: September 2009

Study information

• Verified date: June 2011
• Source: Northern State Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• intravenous analgesia
Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h
• epidural infusion
Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL
• patient-controlled epidural analgesia
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.

Locations

Country	Name	City	State
Russian Federation	Dep. of Anesthesiology, Northern SMU	Arkhangelsk

Sponsors (2)

Lead Sponsor	Collaborator
Northern State Medical University	University of Tromso

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes