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NCT Number: NCT01384175

Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Anesthesiology, Northern SMU

Arkhangelsk, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous analgesia

Procedure

Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h

epidural infusion

Procedure

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

Procedure

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.

Primary outcomes

  1. Duration of postoperative mechanical ventilation

    Time frame: Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours

    Duration of postoperative mechanical ventilation, hours

Secondary outcomes

  1. Hemodynamic stability

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Northern State Medical University

Other

Collaborators

  • University of Tromso

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 28, 2011
Registry last updated
Jun 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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