Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG (NCT02727712) | Clinical Trial Compass
UnknownPhase 4
Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG
China60 participantsStarted 2016-04
Plain-language summary
This study intends to compare the combination of general anesthesia (GA) and single-shot bilateral thoracic paravertebral block (TPVB) by ropivacaine in the patients undergoing off-pump coronary artery bypass surgery ( OPCAB) with traditional general anesthesia (GA) perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an more effective perioperative management during off-pump coronary artery bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.
Who can participate
Age range
35 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute)
* The in - hospital was treated with off pump coronary artery bypass grafting(CABG) operation and general anesthesia.
* Had a good cognition, and signed the informed consent.
* Aged between 35 and 80.
* The age, clinical examination and other generally situation of the two groups of patients had no statistical significance.
no merger of valvular disease left ventricular ejection fraction \> 40%, do not need intraaortic balloon counterpulsation support, without spinal deformity, no vertebral side clearance space-occupying lesions
Exclusion Criteria:
* Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease.
* Patients with severe mental disorders cannot cooperate with the treatment.
* Emergency operation
* Have taboo of Echocardiography and pulmonary catheterization by echocardiography.
* Allergic to Local anesthetics drug.
* Suspected or had alcohol, drug abuse history.
* Spinal or paravertebral lesions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fasting blood glucose
Timeframe: baseline and 4 days
2
Blood Lactic Acid
Timeframe: baseline and 4 days
3
Creatine kinase isoenzymes
Timeframe: baseline and 4 days
4
Myoglobin
Timeframe: baseline and 4 days
5
Troponin I
Timeframe: baseline and 4 days
6
White Blood Cell
Timeframe: baseline and 4 days
7
C-reactive protein
Timeframe: baseline and 4 days
8
N-terminal B-type natriuretic peptide(NT-proBNP)
Timeframe: baseline and 4 days
Trial details
NCT IDNCT02727712
SponsorXiangya Hospital of Central South University