Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Desflurane Versus Propofol Anesthesia for Off-Pump CABG

NCT00528515

Coronary Artery Disease

COMPLETED PHASE4

Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG

NCT02727712

Coronary Heart Disease

UNKNOWN PHASE4

LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

NCT05136794

Opioid Free Anaesthesia Opioid Anaesthesia

COMPLETED

Anesthesia and Lymphocytes Apoptosis

NCT01461551

Anesthesia

COMPLETED NA

Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery

NCT04137991

Nociceptive Pain Goal-directed Therapy Hemodynamic Instability +5 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intravenous analgesia

Patients received postoperative analgesia by intravenous fentanyl 10 µg/ml 3-8 mL/h.

Group Type ACTIVE_COMPARATOR

intravenous analgesia

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

epidural infusion

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

patient-controlled epidural analgesia

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

intravenous analgesia

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

Intervention Type PROCEDURE

epidural infusion

Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No