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

Not Applicable

Recruiting

• Conditions: Erector Spinae Plane Block; Pecto-intercostal Fascial Plane Block; Recto-intercostal Fascial Plane Block; Cardiac; Surgery
• Interventions: Drug: Erector spinae plane block; Drug: Combined Pecto-intercostal and recto-intercostal fascial plane block

• Registration Number: NCT06870383
• Lead Sponsor: Tanta University

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-11
• Study Start: 2025-03-20
• Last Update Submitted: 2025-04-05
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-09-20
• Study Completion: 2025-09-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae plane block group	Erector spinae plane block	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.
Combined Pecto-intercostal and recto-intercostal fascial plane block group	Combined Pecto-intercostal and recto-intercostal fascial plane block	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.

Primary Outcome Measures

Name	Time	Method
The total opioid consumption in first 24 hours after surgery.	24 hours after surgery.	opioid analgesia will be given if the pain scores ≥ 4.

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl dose	Until the end of surgical procedure.	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.
Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.	48 hours 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.
Extubation time	24 hours after surgery.	Time from intensive care unit admission until successful removal of endotracheal tube will be recorded.
Side effects	24 hours after surgery.	Hypotension , bradycardia, postoperative nausea and vomiting
Incidence of chronic pain at 3, and 6 months after surgery.	6 months after surgery.	chronic pain will be assessed and its severity graded by rating scale will be recorded.
Opioid consumption in the second day after surgery.	48 hours after surgery.	opioid analgesia will be given if the pain scores ≥ 4.

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbia, Egypt