Clinical trial NCT06870383: Erector Spinae Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Cardiac Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erector Spinae Plane Block
Pecto-intercostal Fascial Plane Block
Recto-intercostal Fascial Plane Block
Cardiac
Surgery
Keywords: Analgesic
Erector
Pectointercostal
Rectointercostal
Cardiac
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The total opioid consumption in first 24 hours after surgery.
timeFrame: 24 hours after surgery.
Secondary outcomes:
measure: Intraoperative fentanyl dose
timeFrame: Until the end of surgical procedure.
measure: Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.
timeFrame: 48 hours after surgery.
measure: Extubation time
timeFrame: 24 hours after surgery.
measure: Side effects
timeFrame: 24 hours after surgery.
measure: Incidence of chronic pain at 3, and 6 months after surgery.
timeFrame: 6 months after surgery.
measure: Opioid consumption in the second day after surgery.
timeFrame: 48 hours after surgery.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Gharbia
Study officials:
References: