Parasternal Block in Pediatric Patients Undergoing Cardiac Surgery

NCT05539885 | Unknown

• 1 other identifier: Parasternal block
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pectointercostal Fascial Plane Block

Keywords

pectointercostal fascial plane block; pediatrics; open cardiac surgery; optimal timing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Postoperative pain score:

  at extubation, 2nd, 6th, 12th, 16th, 20th, and 24th hour after extubation.

• Intraoperative fentanyl consumption

  time of surgery

Study Arms (2)

Pre-incisional PIFB

ACTIVE COMPARATOR

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

Post-incisional PIFB

ACTIVE COMPARATOR

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

Interventions

Pre-incisional Ultrasound guided (PIFP) block PROCEDURE

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.

Also known as: Pectointercostal fascial plane block

Pre-incisional PIFB

Post-incisional Surgeon delivered parasternal block group PROCEDURE

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.

Post-incisional PIFB

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Pollak U, Serraf A. Pediatric Cardiac Surgery and Pain Management: After 40 Years in the Desert, Have We Reached the Promised Land? World J Pediatr Congenit Heart Surg. 2018 May;9(3):315-325. doi: 10.1177/2150135118755977.

  PMID: 29692232 BACKGROUND

• Roy N, Parra MF, Brown ML, Sleeper LA, Nathan M, Sefton BA, Baird CW, Mistry KP, Del Nido PJ. Initial experience introducing an enhanced recovery program in congenital cardiac surgery. J Thorac Cardiovasc Surg. 2020 Nov;160(5):1313-1321.e5. doi: 10.1016/j.jtcvs.2019.10.049. Epub 2019 Oct 24.

  PMID: 31859070 BACKGROUND

• Zhang Y, Chen S, Gong H, Zhan B. Efficacy of Bilateral Transversus Thoracis Muscle Plane Block in Pediatric Patients Undergoing Open Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Sep;34(9):2430-2434. doi: 10.1053/j.jvca.2020.02.005. Epub 2020 Feb 11.

  PMID: 32151511 BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Mohamed Ahmed Ali Ahmed, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Ahmed Ali Ahmed, MD

CONTACT

+201008707460; drmoali@yahoo.com

Alaa Attia, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant of Anesthesia & Pain management, Faculty of Medicine

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: October 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share