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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04945694
Enrollment
80
Registered
2021-06-30
Start date
2021-08-31
Completion date
2022-08-31
Last updated
2021-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Patients, Congenital Heart Surgery

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.

Interventions

OTHERUltrasound-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

In this group, patients will receive only incremental doses of intravenous fentanyl

DRUGPropofol

Propofol anesthesia

DRUGSevoflurane

Sevoflurane anesthesia

Intravenous atracurium

DEVICEultrasound

ultrasound-guided block

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain assessmentPostoperative day 1Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.
Total dose of fentanyl requirementsintraoperative and 24 hrs postoperativelyTotal dose of fentanyl requirements

Secondary

MeasureTime frame
Serum cortisol levelsBasal 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

Countries

Egypt

Contacts

Primary ContactMohamed A Ghanem, MD'
mohamed.abdel_latif@yahoo.com00201067883998
Backup ContactEnas Abd Elmotlb, MD
sevo2006@gmail.com00201005401236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026