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Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

This study has been completed.
Sponsor:
Collaborator:
University of Tromso
Information provided by:
Northern State Medical University
ClinicalTrials.gov Identifier:
NCT01384175
First received: June 17, 2011
Last updated: June 28, 2011
Last verified: June 2011
History of Changes

June 17, 2011
June 28, 2011
January 2008
August 2009   (final data collection date for primary outcome measure)
Duration of postoperative mechanical ventilation [ Time Frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours ] [ Designated as safety issue: No ]
Duration of postoperative mechanical ventilation, hours
Same as current
Complete list of historical versions of study NCT01384175 on ClinicalTrials.gov Archive Site
Hemodynamic stability [ Time Frame: All period of operation and during 24 hours postoperatively ] [ Designated as safety issue: Yes ]
Hemodynamic stability as assessed by mean arterial pressure, heart rate, cardiac index, requirement of inotrops/vasoactives and colloids
Same as current
Not Provided
Not Provided
 
Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl
Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Procedure: intravenous analgesia
    Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h
  • Procedure: epidural infusion
    Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL
  • Procedure: 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.
  • Active Comparator: intravenous analgesia
    Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.
    Intervention: Procedure: intravenous analgesia
  • Active Comparator: epiduaral 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.
    Intervention: Procedure: epidural infusion
  • Active Comparator: 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.
    Intervention: Procedure: patient-controlled epidural analgesia
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01384175
OPCAB-EA
No
Mikhail Kirov, Professor, Northern State Medical University
Northern State Medical University
University of Tromso
Study Director: Mikhail Y Kirov Northern State Medical University
Northern State Medical University
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP