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

NCT04945694 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-06-30

No results posted yet for this study

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.

Conditions

  • Pediatric Patients
  • Congenital Heart Surgery

Interventions

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

DRUG

Propofol

Propofol anesthesia

DRUG

Sevoflurane

Sevoflurane anesthesia

DRUG

Atracurium

Intravenous atracurium

DEVICE

ultrasound

ultrasound-guided block

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamed A Ghanem, MD · Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

  • Enas Abd Elmotlb, MD · professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2022-02-28
Completion
2022-08-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04945694 on ClinicalTrials.gov