Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery

Not Applicable

Not yet recruiting

• Conditions: Pectointercostal Fascial Plane Block
• Interventions: Procedure: Post-incisional Surgeon delivered parasternal block group; Procedure: Pre-incisional Ultrasound guided (PIFP) block

• Registration Number: NCT05539885
• Lead Sponsor: Assiut University

Brief Summary

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).

Detailed 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.)

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19
• Study Start: 2022-10
• Primary Completion: 2023-05
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Post-incisional PIFB	Post-incisional Surgeon delivered parasternal block group	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.
Pre-incisional PIFB	Pre-incisional Ultrasound guided (PIFP) block	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.

Primary Outcome Measures

Name	Time	Method
Time to first analgesia request.	24 hours	The first analgesic request after extubation
Amount of rescue analgesia.	24 hours	Amount of rescue analgesia (total dose of fentanyl) after extubation.

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	time of surgery
Postoperative pain score:	at extubation, 2nd, 6th, 12th, 16th, 20th, and 24th hour after extubation.	Postoperative pain will be assessed by modified objective pain score (MOPS) in children at 0, 2, 6, 12, 16, 20, and 24 h after extubation. Wilson and Doyle modified the objective pain score by replacing blood pressure with posture. MOPS consists of 5 items (crying, movements, agitations, posture, and verbal). The minimum score is 0 (No pain) and the maximum is 10 (most sever pain).