Clinical trial NCT02727712: Studies of Application of Combined General Anesthesia and Bilateral TPVB in OPCABG
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Heart Disease
Keywords: coronary artery bypass graft
thoracic paravertebral block
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fasting blood glucose
timeFrame: baseline and 4 days
measure: Blood Lactic Acid
timeFrame: baseline and 4 days
measure: Creatine kinase isoenzymes
timeFrame: baseline and 4 days
measure: Myoglobin
timeFrame: baseline and 4 days
measure: Troponin I
timeFrame: baseline and 4 days
measure: White Blood Cell
timeFrame: baseline and 4 days
measure: C-reactive protein
timeFrame: baseline and 4 days
measure: N-terminal B-type natriuretic peptide（NT-proBNP)
timeFrame: baseline and 4 days
Secondary outcomes:
measure: Perioperative major adverse events
timeFrame: From pre-surgery to discharge, up to 4 weeks
measure: Perioperative use of vasoactive drug species
timeFrame: From pre-surgery to discharge, up to 4 weeks
measure: Vasoactive drugs Support Hours
timeFrame: From the start of drugs to stop them, up to 4 weeks
measure: Time after deactivation of vasoactive drugs
timeFrame: From the end of surgery to the deactivation of vasoactive drugs, up to 4 weeks
measure: Postoperative tracheal tube time
timeFrame: From the end of surgery to the removal of tracheal tube, up to 4 weeks
measure: Duration of mechanical ventilation after surgery
timeFrame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
measure: The time after the ICU until discharge
timeFrame: From leaving the ICU to discharge from hospital, up to 4 weeks
measure: Length of ICU stay
timeFrame: From ICU admission to discharge from ICU, up to 4 weeks
measure: Recovery time
timeFrame: From the end of surgery to recover, up to 4 weeks
measure: Time to first bowel movement
timeFrame: From the end of surgery to first bowel movement, up to 2 weeks
measure: Postoperative to normal eating time
timeFrame: From the end of surgery to normal eating, up to 2 weeks
measure: The total length of hospital stay
timeFrame: From admission to discharge, up to 5 weeks
measure: Visual analog pain score
timeFrame: From the end of surgery, up to 48 hours
measure: Ramsay score
timeFrame: From the end of surgery, up to 48 hours
Other outcomes:
measure: The scores of mini-mental state examination
timeFrame: From the end of surgery, up to 48 hours
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: e wang, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.