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

Pediatric Patients Clinical Trial

Official title:

Ultrasound-Guided Bilateral Pecto-intercostal Fascial Block Versus Intravenous Fentanyl for Postoperative Pain Management After Pediatric Cardiac Surgery A Prospective, Randomized, Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04945694
• Other study ID #: MD/ 21.04.462
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2021
• Est. completion date: August 2022

Study information

• Verified date: June 2021
• Source: Mansoura University
• Contact: Mohamed A Ghanem, MD'
• Phone: 00201067883998
• Email: mohamed.abdel_latif[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Surgery
• Pediatric Patients

Intervention

Other:
• Ultrasound-guided bilateral pecto-intercostal fascial block
- PATIENT IN SUPINE POSITION, SKIN WILL BE DISINFECTED, A HIGH-FREQUENCY LINEAR PROBE WILL BE PLACED PARALLEL TO LONGITUDINAL AXIS OF STERNUM ON LATERAL BORDER AND SCANNED LATERALLY TO IDENTIFY 4TH AND 5TH COSTAL CARTILAGE. THE PECTORALIS MAJOR MUSCLE (PMM), INTERNAL INTERCOSTAL MUSCLE (IIM), TRANSVERSUS THORACIS MUSCLE (TTM), RIBS, AND PLEURA WILL BE IDENTIFIED. COLOR DOPPLER ULTRASONOGRAPHY WILL BE USED TO DETERMINE PERFORATING BRANCHES OF INTERNAL THORACIC ARTERY, WHICH TRAVEL ANTERIORLY THROUGH THE ANTERIOR CHEST WALL, PIERCING THE INTERCOSTAL MUSCLE AND PMM. A 22G NEEDLE WILL BE INSERTED IN PLANE WITH PROBE, IN CAUDAL-TO-CRANIAL DIRECTION UNTIL THE TIP IS POSITIONED IN INTER- FASCIAL PLANE BETWEEN THE PMM AND IIM. NORMAL SALINE WILL BE USED TO DETERMINE CORRECT PLACEMENT OF NEEDLE TIP IN INTER-FASCIAL PLANE, AS SHOWN BY SEPARATION OF FASCIAL LAYERS THEN LOCAL ANESTHETIC WILL BE INJECTED

Drug:
• Intravenous fentanyl
In this group, patients will receive only incremental doses of intravenous fentanyl
• Propofol
Propofol anesthesia
• Sevoflurane
Sevoflurane anesthesia
• Atracurium
Intravenous atracurium

Device:
• ultrasound
ultrasound-guided block

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain assessment	Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.	Postoperative day 1
Primary	Total dose of fentanyl requirements	Total dose of fentanyl requirements	intraoperative and 24 hrs postoperatively
Secondary	Serum cortisol levels		Basal and one-hour postoperatively
Secondary	Heart rate [HR]		before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Secondary	Invasive mean arterial blood pressure [MAP]		before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum