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

Central South University

Status and phase: Unknown; Phase 4

Conditions: Coronary Heart Disease

Treatments: Device: Transesophageal Echocardiography（TEE）; Drug: Anesthesia drugs during the surgery; Procedure: bilateral thoracic paravertebral block; Device: Lung protection measure during the surgery（Dräger Primus）; Procedure: thoracic paravertebral block

Study type: Interventional

Funder types: Other

Identifiers

NCT02727712

20160131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

TPVB T2/3+T5/6+GA

Experimental group

Description:

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

Treatment:

Device: Transesophageal Echocardiography（TEE）

Drug: Anesthesia drugs during the surgery

Device: Lung protection measure during the surgery（Dräger Primus）

Procedure: bilateral thoracic paravertebral block

TPVB T3/4+GA

Experimental group

Description:

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

Treatment:

Device: Transesophageal Echocardiography（TEE）

Drug: Anesthesia drugs during the surgery

Device: Lung protection measure during the surgery（Dräger Primus）

Procedure: thoracic paravertebral block

GA

Placebo Comparator group

Description:

group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery

Treatment:

Device: Transesophageal Echocardiography（TEE）

Drug: Anesthesia drugs during the surgery

Device: Lung protection measure during the surgery（Dräger Primus）