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

NCT05320718 | Completed DMC

• 1 other identifier: ESPB vs PVB for MIDCAB
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

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.

Conditions

Regional Anesthesia; Anesthesia, Local; Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• pain at rest after surgery

  postoperatively 0-3 day

• adverse events of regional block

  Intraoperative (during and immediately after block performance)

• dermatome of block

  immediately after extubation

Other Outcomes (10)

• pulmonary function

  preoperative and postoperative day 1 and 3

• postoperative complications: cardiac, pulmonary, cerebral, opioid intake

  3 days postoperatively

• recovery time

  postoperatively, up to 4 weeks

Study Arms (2)

erector spinae plane block

EXPERIMENTAL

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

thoracic paravertebral block

ACTIVE COMPARATOR

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

Interventions

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

erector spinae plane block; thoracic paravertebral block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective minimally invasive direct coronary artery bypass grafting

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Municipal Health Commission: collaborator

Study Sites (2)

Department of Anesthesiology,Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking University Third Hosptial

Beijing, 100191, China

Location

Related Publications (3)

• 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.

  PMID: 31280100 BACKGROUND

• 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.

  PMID: 33032124 BACKGROUND

• 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.

  PMID: 32502778 BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Min Li, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of the Department of Anesthesiology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 11, 2022
• Study Start: April 15, 2022
• Primary Completion: April 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 23, 2026

Record last verified: 2025-01

Locations

CN (2)