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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Patients included in the study (approximately 60 cases) will be randomly divided into PVB(T2/3+T5/6)+GA experimental group (A), PVB(T3/4)+GA experimental group (B)the conventional GA control group (C). All groups received the preoperative preparation, anesthesia and postoperative treatment according to the traditional manner, the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4), group B will received bilateral thoracic paravertebral block (TPVB T3/4)by ropivacaine(0.3%,20ml*2).,while the group C will received the conventional general anesthesia management without block.

Official Title
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Studies of Application of Combined General Anesthesia and Bilateral Thoracic Paravertebral Block by Ropivacaine in Patients Undergoing Off-pump Coronary Artery Bridge Graft - a Random Double Blind Controlled Study

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Procedure: bilateral thoracic paravertebral block
* Device: Transesophageal Echocardiography（TEE）
* Device: Lung protection measure during the surgery（Dräger Primus）
* Drug: Anesthesia drugs during the surgery
* Procedure: thoracic paravertebral block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TPVB T2/3+T5/6+GA<br>the group A of patients has been received bilateral thoracic paravertebral block (TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4), before general anesthesia management | Procedure: bilateral thoracic paravertebral block<br>* group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4)program<br>Device: Transesophageal Echocardiography（TEE）<br>* Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion; Goal-directed fluid management<br>Device: Lung protection measure during the surgery（Dräger Primus）<br>* Protective ventilation strategy(Low tidal volume about 6 7ml/kg, joint use of PEEP)<br>Drug: Anesthesia drugs during the surgery<br>* Bilateral thoracic paravertebral block before induction of anesthesia; Fast channel anesthesia • Induction use Sufentanil 0.5 1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2 0.6mg/kg; ②. Maintain use Sufentanil Hydrochloride for Injection 0.01 0.04ug/kg•min, Sevoflurane 0.5 1.5MAC（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg•h,Vecuronium 0.06 0.12mg/kg•h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.<br>|
| Experimental: TPVB T3/4+GA<br>the group Bof patients has been received bilateral thoracic paravertebral block (TPVB 3/4) by ropivacaine(0.3%,10ml*4), before general anesthesia management Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery | Device: Transesophageal Echocardiography（TEE）<br>* Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion; Goal-directed fluid management<br>Device: Lung protection measure during the surgery（Dräger Primus）<br>* Protective ventilation strategy(Low tidal volume about 6 7ml/kg, joint use of PEEP)<br>Drug: Anesthesia drugs during the surgery<br>* Bilateral thoracic paravertebral block before induction of anesthesia; Fast channel anesthesia • Induction use Sufentanil 0.5 1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2 0.6mg/kg; ②. Maintain use Sufentanil Hydrochloride for Injection 0.01 0.04ug/kg•min, Sevoflurane 0.5 1.5MAC（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg•h,Vecuronium 0.06 0.12mg/kg•h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.<br>Procedure: thoracic paravertebral block<br>* group B under(TPVB T3/4)by ropivacaine(0.3%,20ml*2)program<br>|
| Placebo Comparator: GA<br>group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery | Device: Transesophageal Echocardiography（TEE）<br>* Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion; Goal-directed fluid management<br>Device: Lung protection measure during the surgery（Dräger Primus）<br>* Protective ventilation strategy(Low tidal volume about 6 7ml/kg, joint use of PEEP)<br>Drug: Anesthesia drugs during the surgery<br>* Bilateral thoracic paravertebral block before induction of anesthesia; Fast channel anesthesia • Induction use Sufentanil 0.5 1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2 0.6mg/kg; ②. Maintain use Sufentanil Hydrochloride for Injection 0.01 0.04ug/kg•min, Sevoflurane 0.5 1.5MAC（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg•h,Vecuronium 0.06 0.12mg/kg•h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose | 1day before and 4days after operation | baseline and 4 days | 
| Blood Lactic Acid | 1day before and 4days after operation | baseline and 4 days | 
| Creatine kinase isoenzymes | 1day before and 4days after operation | baseline and 4 days | 
| Myoglobin | 1day before and 4days after operation | baseline and 4 days | 
| Troponin I | 1day before and 4days after operation | baseline and 4 days | 
| White Blood Cell | 1day before and 4days after operation | baseline and 4 days | 
| C-reactive protein | 1day before and 4days after operation | baseline and 4 days | 
| N-terminal B-type natriuretic peptide（NT-proBNP) | 1day before and 4days after operation | baseline and 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative major adverse events |  | From pre-surgery to discharge, up to 4 weeks | 
| Perioperative use of vasoactive drug species |  | From pre-surgery to discharge, up to 4 weeks | 
| Vasoactive drugs Support Hours |  | From the start of drugs to stop them, up to 4 weeks | 
| Time after deactivation of vasoactive drugs |  | From the end of surgery to the deactivation of vasoactive drugs, up to 4 weeks | 
| Postoperative tracheal tube time |  | From the end of surgery to the removal of tracheal tube, up to 4 weeks | 
| Duration of mechanical ventilation after surgery |  | From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks | 
| The time after the ICU until discharge |  | From leaving the ICU to discharge from hospital, up to 4 weeks | 
| Length of ICU stay |  | From ICU admission to discharge from ICU, up to 4 weeks | 
| Recovery time |  | From the end of surgery to recover, up to 4 weeks | 
| Time to first bowel movement |  | From the end of surgery to first bowel movement, up to 2 weeks | 
| Postoperative to normal eating time |  | From the end of surgery to normal eating, up to 2 weeks | 
| The total length of hospital stay |  | From admission to discharge, up to 5 weeks | 
| Visual analog pain score |  | From the end of surgery, up to 48 hours | 
| Ramsay score |  | From the end of surgery, up to 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery bypass graft, thoracic paravertebral block