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Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

N

Northern State Medical University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Procedure: epidural infusion
Procedure: intravenous analgesia
Procedure: patient-controlled epidural analgesia

Study type

Interventional

Funder types

Other

Identifiers

NCT01384175
OPCAB-EA

Details and patient eligibility

About

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

Full 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.

Enrollment

93 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

93 participants in 3 patient groups

intravenous analgesia
Active Comparator group
Description:
Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.
Treatment:
Procedure: intravenous analgesia
epiduaral infusion
Active Comparator group
Description:
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.
Treatment:
Procedure: epidural infusion
patient-controlled epidural analgesia
Active Comparator group
Description:
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.
Treatment:
Procedure: patient-controlled epidural analgesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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