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

Analgesic Efficacy of Erector Spinae Plane Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Patients Undergoing Cardiac Surgery: A Randomized Comparative Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Erector Spinae Plane Block; Cardiac; Recto-intercostal Fascial Plane Block; Pecto-intercostal Fascial Plane Block
• Intervention / Treatment: Drug: Erector spinae plane block; Drug: Combined Pecto-intercostal and recto-intercostal fascial plane block

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.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Osama M Rehab, MD; Phone Number: 01095210806; Email: osamarehab@med.tanta.edu.eg

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt, 31527
      • Recruiting
      • Tanta University Hospitals
      • Sub-Investigator: Doha M Bakr, MD
      • Principal Investigator: Osama M Rehab, MD
      • Contact: Osama M Rehab, MD; Phone Number: 01095210806; Email: osamarehab@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
Experimental: 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.	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..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl dose	Fentanyl bolus dosages of 2μg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline.	Until the end of surgical procedure.
Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.	Numerical rating scale pain score (NRS) ranges from 0= no pain to 10= worst pain will be used to evaluate pain scores after surgery.	48 hours after surgery.
Extubation time	Time from intensive care unit admission until successful removal of endotracheal tube will be recorded.	24 hours after surgery.
Side effects	Hypotension , bradycardia, postoperative nausea and vomiting	24 hours after surgery.
Incidence of chronic pain at 3, and 6 months after surgery.	chronic pain will be assessed and its severity graded by rating scale will be recorded.	6 months after surgery.
Opioid consumption in the second day after surgery.	opioid analgesia will be given if the pain scores ≥ 4.	48 hours after surgery.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Cardiac; Analgesic; Rectointercostal; Erector; Pectointercostal
• Other Study ID Numbers: 36264PR1085/2/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the corresponding author.
• IPD Sharing Time Frame: After completion of the study.
• IPD Sharing Access Criteria: The data will be available upon reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No