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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
  Purpose

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


Condition Intervention
Coronary Artery Disease
 Procedure: intravenous analgesia
Procedure: epidural infusion
Procedure: patient-controlled epidural analgesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northern State Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 93
Study Start Date: January 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intravenous analgesia
Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.
 Procedure: intravenous analgesia
Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h
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.
 Procedure: epidural infusion
Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL
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.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384175

Locations
Russian Federation
Dep. of Anesthesiology, Northern SMU
Arkhangelsk, Russian Federation
Sponsors and Collaborators
Northern State Medical University
University of Tromso
Investigators
Study Director: Mikhail Y Kirov Northern State Medical University
  More Information

No publications provided

Responsible Party: Mikhail Kirov, Professor, Northern State Medical University
ClinicalTrials.gov Identifier: NCT01384175     History of Changes
Other Study ID Numbers: OPCAB-EA
Study First Received: June 17, 2011
Last Updated: June 28, 2011
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Northern State Medical University:
Epidural Analgesia
OPCAB
PCEA

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anesthetics
Fentanyl
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Anesthetics, Local

ClinicalTrials.gov processed this record on June 18, 2013