Erector Spinae Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Cardiac Surgery

NCT ID: NCT06870383

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-09-20

Brief Summary

The aim of this study is to compare the analgesic effects of ultrasound-guided bilateral erector spinae plane block versus ultrasound-guided bilateral combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.

Detailed Description

The incidence of severe acute postoperative pain after median sternotomy is as high as 49 %. A number of regional techniques have been used to treat sternotomy pain such as thoracic epidural, intercostal nerve block, paravertebral nerve block & thoracic erector spinae plane block which has been used extensively in cardiac surgery providing adequate postoperative pain control. Pecto-intercostal fascial plane block is a minimally invasive, regional fascial plane block technique that can be administered as a part of a multimodal analgesic regimen. It targets the anterior intercostal nerves as they run in the fascial plane between the pectoralis major muscle and the external intercostal muscles and emerge on either side of the sternum. Recently, Tulgar et al. have described a novel block named "recto-intercostal fascial plane block" which is performed between the rectus abdominis muscle and costal cartilages of ribs 6-7 (insertion of RAM). In their cadaveric examination, they reported that the dye spread extensively to the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators assume that the incomplete dermatome coverage by Pecto-intercostal fascial plane block might be responsible for its inferior analgesic quality compared to erector spinae plane block which was reported in some previous reports. So, the investigators will conduct this novel study to investigate and compare the analgesic effects of erector spinae plane block and combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.

Conditions

Erector Spinae Plane Block; Pecto-intercostal Fascial Plane Block; Recto-intercostal Fascial Plane Block; Cardiac; Surgery

Keywords

Analgesic; Erector; Pectointercostal; Rectointercostal; Cardiac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Erector spinae plane block group

At the level of fourth thoracic vertebra, the ultrasound transducer (5-14 Mhz) Philips CX50 will be placed in the sagittal plane and moved 3 cm to visualize the transverse process of T4 or T5 with erector spinae muscle overlying it, the needle will be inserted in plane into the facial plane deep to the erector spinae muscle with the tip contacting the transverse process of T4 or T5. After confirmation by 5 ml saline, 20 ml bupivacaine 0.25% will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose.

Group Type: ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type: DRUG

The block will be done under ultrasound guidance using 20 ml bupivacaine 0.25% that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose.

Combined Pecto-intercostal and recto-intercostal fascial plane block group

A high-frequency ultrasound transducer will be placed 2 cm lateral to sternal edge at the level of 4th rib. A needle will be inserted in-plane under ultrasound guidance through the pectoralis major muscle, and the drug will be deposited in the pecto-intercostal fascial plane located between the pectoralis major muscle and the fourth rib (or intercostal muscle) after confirmation by 5 ml saline. 10-15 mL of 0.25% bupivacaine will be injected for each side. Then the transducer will be placed 2-3 cm lateral and caudal to the xiphoid in the epigastric area.The needle will be inserted between RAM and the costal cartilages with an in-plane technique in a caudo-cranial way. Hydro-dissection will be performed with 5 ml saline for confirmation needle tip position, 10-15 mL of 0.25% bupivacaine will be injected for each side.

Group Type: EXPERIMENTAL

Combined Pecto-intercostal and recto-intercostal fascial plane block

Intervention Type: DRUG

The blocks will be done under ultrasound guidance using 10-15 ml of 0.25% bupivacaine that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose..

Interventions

Erector spinae plane block

The block will be done under ultrasound guidance using 20 ml bupivacaine 0.25% that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose.

Intervention Type: DRUG

Combined Pecto-intercostal and recto-intercostal fascial plane block

The blocks will be done under ultrasound guidance using 10-15 ml of 0.25% bupivacaine that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose..

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age from 21 to 65 years.
• Both sexes.
• Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.

Exclusion Criteria

• History of chronic pain or Long-term or recent use of opioids.
• History of allergy to local anesthetic drugs.
• Ejection fraction of left ventricle less than 30%.
• History of psychiatric diseases or any neurological disorders.
• Pre-existing major organ dysfunction as hepatic or renal failure.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Osama Rehab

lecturer of anesthesiology, surgical intensive care and pain medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospitals

Tanta, Gharbia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Osama M Rehab, MD

Role: CONTACT

Phone: 01095210806

Email: osamarehab@med.tanta.edu.eg

Facility Contacts

Osama M Rehab, MD

Role: primary

Other Identifiers

36264PR1085/2/25

Identifier Type: -

Identifier Source: org_study_id