Clinical trial NCT05320718: Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting: Programmed Intermittent Bolus Infusions of Erector Spinae Plane Block Versus Paravertebral Block
Official title: Comparison of Programmed Intermittent Bolus Infusions of Spinae Plane Block Versus Paravertebral Block for Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia
Anesthesia, Local
Surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Health Commission
First posted: 2022-04-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain at cough after surgery
timeFrame: postoperatively 0-3 day
measure: postoperative rescue analgesic consumption
timeFrame: postoperatively 0-3 day
Secondary outcomes:
measure: pain at rest after surgery
timeFrame: postoperatively 0-3 day
measure: adverse events of regional block
timeFrame: Intraoperative (during and immediately after block performance)
measure: dermatome of block
timeFrame: immediately after extubation
Other outcomes:
measure: pulmonary function
timeFrame: preoperative and postoperative day 1 and 3
measure: postoperative complications: cardiac, pulmonary, cerebral, opioid intake
timeFrame: 3 days postoperatively
measure: recovery time
timeFrame: postoperatively, up to 4 weeks
measure: plasma cortisol
timeFrame: preoperative, 24 hours and 72 hours after operation.
measure: C-reactive protein
timeFrame: preoperative, 24 hours and 72 hours after operation.
measure: plasma troponin T level
timeFrame: preoperative, 24 hours and 72 hours after operation.
measure: patient's satisfaction with regional analgesia
timeFrame: 3 day postoperatively
measure: time to perform the block
timeFrame: immediately before surgery
measure: CK-MB
timeFrame: preoperative, 24 hours and 72 hours after operation
measure: performance in activities of daily living (ADL)
timeFrame: 3 month and 6 month postoperatively
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology,Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hosptial
Study officials:
affiliation: Peking University Third Hospital
name: Min Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.