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Clinical Trials/NCT04945694
NCT04945694
Unknown
Not Applicable

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

Mansoura University1 site in 1 country80 target enrollmentAugust 2021

Overview

Phase
Not Applicable
Intervention
Ultrasound-guided bilateral pecto-intercostal fascial block
Conditions
Pediatric Patients
Sponsor
Mansoura University
Enrollment
80
Locations
1
Primary Endpoint
Total dose of fentanyl requirements
Last Updated
4 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
August 2021
End Date
August 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Arms & Interventions

Ultrasound-guided bilateral pecto-intercostal fascial block

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

Intervention: Ultrasound-guided bilateral pecto-intercostal fascial block

Intravenous fentanyl

Patients will receive only incremental doses of intravenous fentanyl

Intervention: Sevoflurane

Ultrasound-guided bilateral pecto-intercostal fascial block

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

Intervention: Propofol

Ultrasound-guided bilateral pecto-intercostal fascial block

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

Intervention: Sevoflurane

Ultrasound-guided bilateral pecto-intercostal fascial block

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

Intervention: Atracurium

Ultrasound-guided bilateral pecto-intercostal fascial block

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

Intervention: ultrasound

Intravenous fentanyl

Patients will receive only incremental doses of intravenous fentanyl

Intervention: Intravenous fentanyl

Intravenous fentanyl

Patients will receive only incremental doses of intravenous fentanyl

Intervention: Propofol

Intravenous fentanyl

Patients will receive only incremental doses of intravenous fentanyl

Intervention: Atracurium

Outcomes

Primary Outcomes

Total dose of fentanyl requirements

Time Frame: intraoperative and 24 hrs postoperatively

Total dose of fentanyl requirements

Postoperative pain assessment

Time Frame: Postoperative day 1

Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.

Secondary Outcomes

  • Serum cortisol levels(Basal and one-hour postoperatively)
  • 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)
  • 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)

Study Sites (1)

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