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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05320718
• Other study ID #: ESPB vs PVB for MIDCAB
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2022
• Source: Peking University Third Hospital
• Contact: Min Li, MD
• Phone: 086-15611908799
• Email: liminanesth[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: October 1, 2024
• Est. primary completion date: March 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Regional Anesthesia
• Surgery

Intervention

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

Locations

Country	Name	City	State
China	Department of Anesthesiology,Peking University Third Hospital	Beijing	Beijing
China	Peking University Third Hosptial	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Municipal Health Commission

Country where clinical trial is conducted

China, 

References & Publications (3)

Gürkan Y, Aksu C, Kus A, Yörükoglu 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pulmonary function	parameters measured by bedside spirometer, FVC, FEV1, FEV1/VC, FEF25%, FEF50%, FEF25-75, PEF	preoperative and postoperative day 1 and 3
Other	postoperative complications: cardiac, pulmonary, cerebral, opioid intake	incidence of severe arrhythmia, cardiac arrest, pneumonia, atelectasis, pulmonary edema, postoperative delirium, nausea, vomiting	3 days postoperatively
Other	recovery time	Time for extubation, oral intake, chest drain tube removal, discharge from ICU and discharge from hospital	postoperatively, up to 4 weeks
Other	plasma cortisol	The investigator will measure the plasma cortisol level at several time points	preoperative, 24 hours and 72 hours after operation.
Other	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.
Other	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.
Other	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
Other	time to perform the block	from identify the landmark using ultrasound to catheter fixation	immediately before surgery
Other	CK-MB	The investigator will measure the plasma CK-MB level at several time points	preoperative, 24 hours and 72 hours after operation
Other	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
Primary	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
Primary	postoperative rescue analgesic consumption	morphine equivalents	postoperatively 0-3 day
Secondary	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
Secondary	adverse events of regional block	local bleeding, pleural puncture, local anesthetic toxicity	Intraoperative (during and immediately after block performance)
Secondary	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