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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410078
      • Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TPVB T2/3+T5/6+GA; 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; group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4)program; Device: Transesophageal Echocardiography（TEE）; Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion;; Goal-directed fluid management; Device: Lung protection measure during the surgery（Dräger Primus）; Protective ventilation strategy(Low tidal volume about 6~7ml/kg, joint use of PEEP); Drug: Anesthesia drugs during the surgery; 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.
Experimental: TPVB T3/4+GA; 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）; Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion;; Goal-directed fluid management; Device: Lung protection measure during the surgery（Dräger Primus）; Protective ventilation strategy(Low tidal volume about 6~7ml/kg, joint use of PEEP); Drug: Anesthesia drugs during the surgery; 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.; Procedure: thoracic paravertebral block; group B under(TPVB T3/4)by ropivacaine(0.3%,20ml*2)program
Placebo Comparator: GA; 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）; Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion;; Goal-directed fluid management; Device: Lung protection measure during the surgery（Dräger Primus）; Protective ventilation strategy(Low tidal volume about 6~7ml/kg, joint use of PEEP); Drug: Anesthesia drugs during the surgery; 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.

What is the study measuring?

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	Time Frame
Perioperative major adverse events	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
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
Perioperative use of vasoactive drug species	From pre-surgery to discharge, 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
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

Other Outcome Measures

Outcome Measure	Time Frame
The scores of mini-mental state examination	From the end of surgery, up to 48 hours

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Principal Investigator: e wang, phD, Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: coronary artery bypass graft; thoracic paravertebral block
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 20160131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES