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| Name | Class |
|---|---|
| Beijing Municipal Health Commission | OTHER_GOV |
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Paravertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass surgery.
Minimally invasive direct coronary artery bypass grafting has recently gained with popularity in treatment of coronary artery disease. Compared with conventional approach, it has advantages of less trauma and rapid recovery, but postoperative pain is severe, which may increase the risk of cardiopulmonary complications and cause chronic pain. Therefore, perioperative analgesia is crucial in minimally invasive direct coronary artery bypass grafting.
Paravertebral block (PVB) has been regarded as effective regimen for pain control after cardiac surgery. As a novel analgesia technique, erector spinae plane block (ESPB) has been reported to provide effective analgesia after thoracic and cardiac surgery. We hypothesized that the ESPB is non-inferior to PVB in treating pain in minimally invasive direct coronary artery bypass surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| erector spinae plane block | Experimental | A needle is inserted until the tip contacted the T5 transverse process under ultrasound guidance. After confirming the needle tip position, 20 ml of 0.5% ropivacaine was injected in the plane between the erector spinae muscles and transverse process. A catheter is inserted through the needle and then connected to a Programmed Electronic Postoperative Analgesia Pump with a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery |
|
| thoracic paravertebral block | Active Comparator | A needle is inserted into the paravertebral space. After confirming the needle tip position, 20 ml of 0.5% ropivacaine is injected in the paravertebral space. A catheter is inserted through the needle and then connected to a Programmed Electronic Postoperative Analgesia Pump with a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 20 ml of 0.5% ropivacaine as bolus and a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| pain at cough after surgery | Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome) | postoperatively 0-3 day |
| postoperative rescue analgesic consumption | morphine equivalents | postoperatively 0-3 day |
| Measure | Description | Time Frame |
|---|---|---|
| pain at rest after surgery | Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome) | postoperatively 0-3 day |
| adverse events of regional block | local bleeding, pleural puncture, local anesthetic toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| pulmonary function | parameters measured by bedside spirometer, FVC, FEV1, FEV1/VC, FEF25%, FEF50%, FEF25-75, PEF | preoperative and postoperative day 1 and 3 |
| postoperative complications: cardiac, pulmonary, cerebral, opioid intake |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Li, MD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology,Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31280100 | Background | Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4. | |
| 33032124 | Background | Saadawi M, Layera S, Aliste J, Bravo D, Leurcharusmee P, Tran Q. Erector spinae plane block: A narrative review with systematic analysis of the evidence pertaining to clinical indications and alternative truncal blocks. J Clin Anesth. 2021 Feb;68:110063. doi: 10.1016/j.jclinane.2020.110063. Epub 2020 Oct 5. |
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| Intraoperative (during and immediately after block performance) |
| dermatome of block | loss of cold sensation (ice cubes), 3-point scale: 0 = loss of cold sensation, 1=decreased cold sensation, 2 = normal sensation. | immediately after extubation |
incidence of severe arrhythmia, cardiac arrest, pneumonia, atelectasis, pulmonary edema, postoperative delirium, nausea, vomiting
| 3 days postoperatively |
| recovery time | Time for extubation, oral intake, chest drain tube removal, discharge from ICU and discharge from hospital | postoperatively, up to 4 weeks |
| plasma cortisol | The investigator will measure the plasma cortisol level at several time points | preoperative, 24 hours and 72 hours after operation. |
| C-reactive protein | The investigator will measure the plasma C-reactive protein level at several time points | preoperative, 24 hours and 72 hours after operation. |
| plasma troponin T level | The investigator will measure the plasma troponin T level at several time points | preoperative, 24 hours and 72 hours after operation. |
| patient's satisfaction with regional analgesia | Patient overall satisfaction with regional analgesia will be assessed on a 11 point scale, 0=not satisfied at all, 10=extremely satisfied | 3 day postoperatively |
| time to perform the block | from identify the landmark using ultrasound to catheter fixation | immediately before surgery |
| CK-MB | The investigator will measure the plasma CK-MB level at several time points | preoperative, 24 hours and 72 hours after operation |
| performance in activities of daily living (ADL) | Post-operative follow-up phone calls will be used to assess performance in activities of daily living (ADL) with the Barthelindex of ADL | 3 month and 6 month postoperatively |
| Peking University Third Hosptial |
| Beijing |
| 100191 |
| China |
| 32502778 | Background | Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2. |
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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