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NCT Number: NCT05320718

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

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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Key information

Conditions

Regional Anesthesia Anesthesia, Local Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology,Peking University Third Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergoing elective minimally invasive direct coronary artery bypass grafting

Exclusion criteria

  • Contraindications to regional anesthesia (coagulopathy, infection of the skin at the site of needle puncture area, et al)
  • Morbid obesity (body mass index > 35 kg/m2)
  • Allergy to any of the study drugs
  • Chronic opioid use or history of opioid abuse.
  • Inability to understand pain score

Treatment and study plan

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

Primary outcomes

  1. pain at cough after surgery

    Time frame: postoperatively 0-3 day

    Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)

  2. postoperative rescue analgesic consumption

    Time frame: postoperatively 0-3 day

    morphine equivalents

Secondary outcomes

  1. pain at rest after surgery

    Time frame: postoperatively 0-3 day

    Numerical Rating Pain Scale, where 0=No Pain (better outcome) and 10=Intractable Pain (worse outcome)

  2. adverse events of regional block

    Time frame: Intraoperative (during and immediately after block performance)

    local bleeding, pleural puncture, local anesthetic toxicity

  3. dermatome of block

    Time frame: immediately after extubation

    loss of cold sensation (ice cubes), 3-point scale: 0 = loss of cold sensation, 1=decreased cold sensation, 2 = normal sensation.

Other outcomes

  1. pulmonary function

    Time frame: preoperative and postoperative day 1 and 3

    parameters measured by bedside spirometer, FVC, FEV1, FEV1/VC, FEF25%, FEF50%, FEF25-75, PEF

  2. postoperative complications: cardiac, pulmonary, cerebral, opioid intake

    Time frame: 3 days postoperatively

    incidence of severe arrhythmia, cardiac arrest, pneumonia, atelectasis, pulmonary edema, postoperative delirium, nausea, vomiting

  3. recovery time

    Time frame: postoperatively, up to 4 weeks

    Time for extubation, oral intake, chest drain tube removal, discharge from ICU and discharge from hospital

  4. plasma cortisol

    Time frame: preoperative, 24 hours and 72 hours after operation.

    The investigator will measure the plasma cortisol level at several time points

  5. C-reactive protein

    Time frame: preoperative, 24 hours and 72 hours after operation.

    The investigator will measure the plasma C-reactive protein level at several time points

  6. plasma troponin T level

    Time frame: preoperative, 24 hours and 72 hours after operation.

    The investigator will measure the plasma troponin T level at several time points

  7. patient's satisfaction with regional analgesia

    Time frame: 3 day postoperatively

    Patient overall satisfaction with regional analgesia will be assessed on a 11 point scale, 0=not satisfied at all, 10=extremely satisfied

  8. time to perform the block

    Time frame: immediately before surgery

    from identify the landmark using ultrasound to catheter fixation

  9. CK-MB

    Time frame: preoperative, 24 hours and 72 hours after operation

    The investigator will measure the plasma CK-MB level at several time points

  10. performance in activities of daily living (ADL)

    Time frame: 3 month and 6 month postoperatively

    Post-operative follow-up phone calls will be used to assess performance in activities of daily living (ADL) with the Barthelindex of ADL

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Beijing Municipal Health Commission

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2022
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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