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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPVB T2/3+T5/6+GA | Experimental | 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 |
|
| TPVB T3/4+GA | Experimental | 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 |
|
| GA | Placebo Comparator | group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bilateral thoracic paravertebral block | Procedure | group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4)program |
|
| 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 |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| The scores of mini-mental state examination | From the end of surgery, up to 48 hours |
Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| e Wang, phD | Contact | +86 731 84327413 | ewang324@hotmail.com | |
| junjie Zhang, MD | Contact | +86 731 84327411 | proforol2199@163.com |
| Name | Affiliation | Role |
|---|---|---|
| e wang, phD | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central South University | Changsha | Hunan | 410078 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17855198 | Background | Olivier JF, Bracco D, Nguyen P, Le N, Noiseux N, Hemmerling T; Perioperative Cardiac Surgery Research Group (PeriCARG). A novel approach for pain management in cardiac surgery via median sternotomy: bilateral single-shot paravertebral blocks. Heart Surg Forum. 2007;10(5):E357-62. doi: 10.1532/HSF98.20071082. | |
| 10527232 | Result |
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| Transesophageal Echocardiography（TEE） | Device |
|
|
| Lung protection measure during the surgery（Dräger Primus） | Device | Protective ventilation strategy(Low tidal volume about 6~7ml/kg, joint use of PEEP) |
|
| Anesthesia drugs during the surgery | Drug |
|
|
| thoracic paravertebral block | Procedure | group B under(TPVB T3/4)by ropivacaine(0.3%,20ml*2)program |
|
| 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 |
| Ganapathy S, Murkin JM, Boyd DW, Dobkowski W, Morgan J. Continuous percutaneous paravertebral block for minimally invasive cardiac surgery. J Cardiothorac Vasc Anesth. 1999 Oct;13(5):594-6. doi: 10.1016/s1053-0770(99)90015-0. No abstract available. |
| 18603748 | Result | Mehta Y, Arora D, Sharma KK, Mishra Y, Wasir H, Trehan N. Comparison of continuous thoracic epidural and paravertebral block for postoperative analgesia after robotic-assisted coronary artery bypass surgery. Ann Card Anaesth. 2008 Jul-Dec;11(2):91-6. doi: 10.4103/0971-9784.41576. |
| 11426357 | Result | Dhole S, Mehta Y, Saxena H, Juneja R, Trehan N. Comparison of continuous thoracic epidural and paravertebral blocks for postoperative analgesia after minimally invasive direct coronary artery bypass surgery. J Cardiothorac Vasc Anesth. 2001 Jun;15(3):288-92. doi: 10.1053/jcan.2001.23271. |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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