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

NCT06870383 | Recruiting

• 1 other identifier: 36264PR1085/2/25
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Analgesic; Erector; Pectointercostal; Rectointercostal; Cardiac

Outcome Measures

Primary Outcomes (1)

• The total opioid consumption in first 24 hours after surgery.

  opioid analgesia will be given if the pain scores ≥ 4.

  24 hours after surgery.

Secondary Outcomes (6)

• Intraoperative fentanyl dose

  Until the end of surgical procedure.

• Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.

  48 hours after surgery.

• Extubation time

  24 hours after surgery.

• Side effects

  24 hours after surgery.

• Incidence of chronic pain at 3, and 6 months after surgery.

  6 months after surgery.

Study Arms (2)

Erector spinae plane block group

ACTIVE COMPARATOR

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.

Drug: Erector spinae plane block

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

EXPERIMENTAL

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.

Drug: Combined Pecto-intercostal and recto-intercostal fascial plane block

Interventions

Erector spinae plane block 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.

Erector spinae plane block group

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

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

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

Central Study Contacts

Osama M Rehab, MD

CONTACT

01095210806; osamarehab@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: March 20, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: March 17, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the study.
• Access Criteria: The data will be available upon reasonable request from the corresponding author.

Locations

EG (1)