Coronary Heart DiseasePhase 4NCT02727712

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

A Phase 4 study testing bilateral thoracic paravertebral block, Transesophageal Echocardiography（TEE） and Lung protection measure during the surgery（Dräger Primus） in people with Coronary Heart Disease, run by Xiangya Hospital of Central South University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Coronary Heart Disease
What is being tested?: bilateral thoracic paravertebral block, Transesophageal Echocardiography（TEE） and Lung protection measure during the surgery（Dräger Primus）
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteChina
Study dates: Apr 2016to Dec 2016
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

e Wang, phD contact

+86 731 84327413

ewang324@hotmail.com

junjie Zhang, MD contact

+86 731 84327411

proforol2199@163.com

China1 site

Xiangya Hospital of Central South University
Changsha, Hunan, 410078

Other trials in China

About this study

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

Read the 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.

Conditions: Coronary Heart Disease
Being tested: bilateral thoracic paravertebral block, Transesophageal Echocardiography（TEE）, Lung protection measure during the surgery（Dräger Primus）, Anesthesia drugs during the surgery, thoracic paravertebral block
Keywords: coronary artery bypass graft, thoracic paravertebral block
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bilateral thoracic paravertebral blockProcedure or surgery
group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4)program
Transesophageal Echocardiography（TEE）Device
1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion;
2. Goal-directed fluid management
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 surgeryDrug
1. Bilateral thoracic paravertebral block before induction of anesthesia;
2. 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.
thoracic paravertebral blockProcedure or surgery
group B under(TPVB T3/4)by ropivacaine(0.3%,20ml*2)program

Study groups in NCT02727712
Study group	Role	What they receive
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 Receives: Procedure: bilateral thoracic paravertebral block; Device: Transesophageal Echocardiography（TEE）; Device: Lung protection measure during the surgery（Dräger Primus）; Drug: Anesthesia drugs during the surgery
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 Receives: Device: Transesophageal Echocardiography（TEE）; Device: Lung protection measure during the surgery（Dräger Primus）; Drug: Anesthesia drugs during the surgery; Procedure: thoracic paravertebral block
GA	Placebo comparator	group C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery Receives: Device: Transesophageal Echocardiography（TEE）; Device: Lung protection measure during the surgery（Dräger Primus）; Drug: Anesthesia drugs during the surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Dec 2016

First posted5 Apr 2016 (estimated)
Study startApr 2016
Primary completionSep 2016 (estimated)
Study completionDec 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02727712
Sponsor's protocol ID: 20160131
Status last verified: Mar 2016
First submitted: 22 Feb 2016
Last updated: 5 Apr 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Yes

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.
PubMed 17855198
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.
PubMed 10527232
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.
PubMed 18603748
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.
PubMed 11426357

Want to know more?

e Wang, phD

+86 731 84327413

ewang324@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02727712
Acronym / sponsor ID: 20160131
Conditions: Coronary Heart Disease
Keywords: coronary artery bypass graft, thoracic paravertebral block
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (estimated)
Lead sponsor: Xiangya Hospital of Central South UniversityUniversity, hospital or other
Study start: Apr 2016
Primary completion: Sep 2016 (estimated)
Study completion: Dec 2016 (estimated)
First posted: 5 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TPVB T2/3+T5/6+GA	Experimental	Procedure: bilateral thoracic paravertebral block, Device: Transesophageal Echocardiography（TEE）, Device: Lung protection measure during the surgery（Dräger Primus）, Drug: Anesthesia drugs during the surgerythe 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	Device: Transesophageal Echocardiography（TEE）, Device: Lung protection measure during the surgery（Dräger Primus）, Drug: Anesthesia drugs during the surgery, Procedure: thoracic paravertebral blockthe 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	Device: Transesophageal Echocardiography（TEE）, Device: Lung protection measure during the surgery（Dräger Primus）, Drug: Anesthesia drugs during the surgerygroup C under control (without TPVB)program Device: The use of Transesophageal Echocardiography（TEE）、STAT PROFILE® and Haemonetics® during the surgery

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bilateral thoracic paravertebral blockgroup A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4)program	Procedure or surgery	TPVB T2/3+T5/6+GA
Transesophageal Echocardiography（TEE）1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion; 2. Goal-directed fluid management	Device	GA, TPVB T2/3+T5/6+GA, TPVB T3/4+GA
Lung protection measure during the surgery（Dräger Primus）Protective ventilation strategy(Low tidal volume about 6~7ml/kg, joint use of PEEP)	Device	GA, TPVB T2/3+T5/6+GA, TPVB T3/4+GA
Anesthesia drugs during the surgery1. Bilateral thoracic paravertebral block before induction of anesthesia; 2. 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.	Drug	GA, TPVB T2/3+T5/6+GA, TPVB T3/4+GA
thoracic paravertebral blockgroup B under(TPVB T3/4)by ropivacaine(0.3%,20ml*2)program	Procedure or surgery	TPVB T3/4+GA

Primary outcome

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

14 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
Background: PubMed 17855198Olivier 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.
Results publication: PubMed 10527232Ganapathy 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.
Results publication: PubMed 18603748Mehta 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.
Results publication: PubMed 11426357Dhole 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.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

e Wang, phD contact

+86 731 84327413

ewang324@hotmail.com

junjie Zhang, MD contact

+86 731 84327411

proforol2199@163.com

e wang, phD principal investigator

Xiangya Hospital of Central South University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact e Wang, phD (+86 731 84327413, ewang324@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting blood glucose (time frame: baseline and 4 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02727712, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.