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

Not Applicable

Completed

• Conditions: Regional Anesthesia; Surgery; Anesthesia, Local
• Interventions: Drug: Ropivacaine

• Registration Number: NCT05320718
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2022-03-01
• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-04-02
• Study First Posted: 2022-04-11
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erector spinae plane block	Ropivacaine	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	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
postoperative rescue analgesic consumption	postoperatively 0-3 day	morphine equivalents
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)

Secondary Outcome Measures

Name	Time	Method
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.
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

Trial Locations

Locations (2)

Department of Anesthesiology,Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hosptial; 🇨🇳 Beijing, China