Anesthesia, Local, Regional Anesthesia, Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGRopivacaine
20 ml of 0.5% ropivacaine as bolus and a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery
Sponsors
Peking University Third Hospital
Beijing Municipal Health Commission
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing elective minimally invasive direct coronary artery bypass grafting
Exclusion criteria
1. Contraindications to regional anesthesia (coagulopathy, infection of the skin at the site of needle puncture area, et al) 2. Morbid obesity (body mass index \> 35 kg/m2) 3. Allergy to any of the study drugs 4. Chronic opioid use or history of opioid abuse. 5. Inability to understand pain score
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain at cough after surgery | postoperatively 0-3 day | Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome) |
| postoperative rescue analgesic consumption | postoperatively 0-3 day | morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain at rest after surgery | postoperatively 0-3 day | Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome) |
| adverse events of regional block | Intraoperative (during and immediately after block performance) | local bleeding, pleural puncture, local anesthetic toxicity |
| dermatome of block | immediately after extubation | loss of cold sensation (ice cubes), 3-point scale: 0 = loss of cold sensation, 1=decreased cold sensation, 2 = normal sensation. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORMin Li, MD
Peking University Third Hospital
Outcome results
None listed