Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.)

Official Title
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Optimal Timing of Parasternal Intercostal Nerve Block in Pediatric Patients Undergoing Cardiac Surgery

Conditions
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Pectointercostal Fascial Plane Block

Intervention / Treatment
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* Procedure: Pre-incisional Ultrasound guided (PIFP) block
* Procedure: Post-incisional Surgeon delivered parasternal block group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-incisional PIFB<br>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. | Procedure: Pre-incisional Ultrasound guided (PIFP) block<br>* Patients in group P will be injected with 0.4 mL/kg of 0.25 bupivacaine in the fascial plane between the internal intercostal and pectoralis major muscles on each side of the sternum after induction of anesthesia and before skin incision under ultrasound guidance.<br>* Other names: Pectointercostal fascial plane block;|
| Active Comparator: Post-incisional PIFB<br>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. | Procedure: Post-incisional Surgeon delivered parasternal block group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesia request. | The first analgesic request after extubation | 24 hours | 
| Amount of rescue analgesia. | Amount of rescue analgesia (total dose of fentanyl) after extubation. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score: | 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). | at extubation, 2nd, 6th, 12th, 16th, 20th, and 24th hour after extubation. | 
| Intraoperative fentanyl consumption |  | time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pectointercostal fascial plane block, pediatrics, open cardiac surgery, optimal timing