Clinical trial NCT04945694: Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Patients
Congenital Heart Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain assessment
timeFrame: Postoperative day 1
measure: Total dose of fentanyl requirements
timeFrame: intraoperative and 24 hrs postoperatively
Secondary outcomes:
measure: Serum cortisol levels
timeFrame: Basal and one-hour postoperatively
measure: Heart rate [HR]
timeFrame: 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
measure: Invasive mean arterial blood pressure [MAP]
timeFrame: 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
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
name: Mohamed A Ghanem, MD
role: STUDY_DIRECTOR
affiliation: professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
name: Enas Abd Elmotlb, MD
role: STUDY_CHAIR
References: