Analgesia in Minimally Invasive Direct Coronary Artery Bypass Grafting: Programmed Intermittent Bolus Infusions of Erector Spinae Plane Block Versus Paravertebral Block

Comparison of Programmed Intermittent Bolus Infusions of Spinae Plane Block Versus Paravertebral Block for Analgesia 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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Surgery; Regional Anesthesia
• Intervention / Treatment: Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hosptial
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Department of Anesthesiology,Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: erector spinae plane block; 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	Drug: Ropivacaine; 20 ml of 0.5% ropivacaine as bolus and a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery
Active Comparator: thoracic paravertebral block; 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.	Drug: Ropivacaine; 20 ml of 0.5% ropivacaine as bolus and a programmed intermittent bolus of 10 ml ropivacaine 0.2% every 2 h after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Municipal Health Commission
• Investigators: Principal Investigator: Min Li, MD, Peking University Third Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: ESPB vs PVB for MIDCAB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No