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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06870383
Enrollment
66
Registered
2025-03-11
Start date
2025-03-20
Completion date
2027-01-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Analgesic, Erector, Pectointercostal, Rectointercostal, Cardiac

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.

Interventions

DRUGErector 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.

DRUGCombined 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..

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double blinded

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Intraoperative fentanyl doseUntil 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 time24 hours after surgery.Time from intensive care unit admission until successful removal of endotracheal tube will be recorded.
Side effects24 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026