Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery

Mansoura University

Status: Unknown

Conditions: Pediatric Patients; Congenital Heart Surgery

Treatments: Drug: Sevoflurane; Drug: Atracurium; Device: ultrasound; Other: Ultrasound-guided bilateral pecto-intercostal fascial block; Drug: Propofol; Drug: Intravenous fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT04945694

MD/ 21.04.462

Details and patient eligibility

About

Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site.

In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children.

Pectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.

Full description

The aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. The secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.

Enrollment: 80 estimated patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• On pump
• Elective repair of congenital simple left to right intracardiac shunt
• Median sternotomy

Exclusion criteria

• Refusal of their guardians
• Redo cardiac surgery
• Previous back injury
• Previous back surgery
• Kyphoscoliosis
• Local infection of the skin and subcutaneous tissue at the site of needle puncture
• Hypersensitivity to local anesthetics
• Coagulation disorders
• Renal disease
• Hepatic disease
• Pulmonary disease
• Heart failure
• Moderate to severe pulmonary hypertension.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups, including a placebo group

Ultrasound-guided bilateral pecto-intercostal fascial block

Experimental group

Description:

Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block

Treatment:

Drug: Propofol

Device: ultrasound

Other: Ultrasound-guided bilateral pecto-intercostal fascial block

Drug: Atracurium

Drug: Sevoflurane

Intravenous fentanyl

Placebo Comparator group

Description:

Patients will receive only incremental doses of intravenous fentanyl

Treatment:

Drug: Propofol

Drug: Intravenous fentanyl

Drug: Atracurium

Drug: Sevoflurane