Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery

Assiut University

Status: Not yet enrolling

Conditions: Pectointercostal Fascial Plane Block

Treatments: Procedure: Post-incisional Surgeon delivered parasternal block group; Procedure: Pre-incisional Ultrasound guided (PIFP) block

Study type: Interventional

Funder types: Other

Identifiers

NCT05539885

Parasternal block

Details and patient eligibility

About

The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block in children undergoing congenital heart surgery is associated with differences in outcomes when compared to ultrasound-guided pre-incisional parasternal block in the form of Pectointercostal fascial plane block (PIFB).

Full description

Although many studies have found that pre-incisional parasternal block is effective in preventing postoperative sternotomy pain, we found no randomized controlled trials comparing pre-incisional vs post-incisional parasternal block in pediatric patients except for one retrospective cohort study done by Lisa et al comparing surgeon-delivered local anesthetic wound infiltration vs postoperative bilateral Petco-Intercostal Fascial Blocks. The post-incisional parasternal block may give prolonged postoperative pain control (equivalent to analgesia duration of pre-incisional parasternal block plus the duration of the operative procedure.)

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Acyanotic Congenital heart disease; ASD (atrial septal defect), VSD (ventricular septal defect), and CAVC (common atrioventricular canal).

Elective open-heart surgery via median sternotomy and under CPB (cardiopulmonary bypass).

Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation.

Exclusion criteria

Previous, urgent, or emergent cardiac surgery. Children with cyanotic congenital heart disease. local infection of the skin at the site of needle puncture, Allergy to bupivacaine, Coagulation disorders, Clinically significant liver or kidney disease, Heart failure or severe pulmonary hypertension.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Pre-incisional PIFB

Active Comparator group

Description:

Group P (ultrasound guided parasternal; PIFP block): patients will be injected with 0.4 mL/kg 0.25 bupivacaine in the fascial plane between the pectoralis major and internal intercostal muscles on each side of the sternum after induction of anesthesia and before skin incision under ultrasound guidance.

Treatment:

Procedure: Pre-incisional Ultrasound guided (PIFP) block

Post-incisional PIFB

Active Comparator group

Description:

Group S: After sternal closure, the surgeon will inject bupivacaine (0.5- to 2-mL aliquots depending on the weight) in the fascial plane under direct vision between the 5 anterior (2nd-6th) intercostal spaces on each side 1 to 1.5 cm lateral to the sternal edge using 25-gauge, 50 mm needle. The surgeon will inject the same dose and concentration of bupivacaine used in the ultrasound technique. This technique was prescribed before by Chaudhary et al (23). In both techniques, the maximum dose of bupivacaine will never be exceeded (2 mg/kg). In addition, all patients were administered 2 mL of 0.25% bupivacaine at the site of the mediastinal drain location.

Treatment:

Procedure: Post-incisional Surgeon delivered parasternal block group