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

NCT ID: NCT04945694

Last Updated: 2021-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-31

Study Completion Date

2022-08-31

Brief Summary

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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

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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.

Conditions

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Pediatric Patients Congenital Heart Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound-guided bilateral pecto-intercostal fascial block

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

Group Type EXPERIMENTAL

Ultrasound-guided bilateral pecto-intercostal fascial block

Intervention Type OTHER

\- 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

Propofol

Intervention Type DRUG

Propofol anesthesia

Sevoflurane

Intervention Type DRUG

Sevoflurane anesthesia

Atracurium

Intervention Type DRUG

Intravenous atracurium

ultrasound

Intervention Type DEVICE

ultrasound-guided block

Intravenous fentanyl

Patients will receive only incremental doses of intravenous fentanyl

Group Type PLACEBO_COMPARATOR

Intravenous fentanyl

Intervention Type DRUG

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

Propofol

Intervention Type DRUG

Propofol anesthesia

Sevoflurane

Intervention Type DRUG

Sevoflurane anesthesia

Atracurium

Intervention Type DRUG

Intravenous atracurium

Interventions

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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

Intervention Type OTHER

Intravenous fentanyl

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

Intervention Type DRUG

Propofol

Propofol anesthesia

Intervention Type DRUG

Sevoflurane

Sevoflurane anesthesia

Intervention Type DRUG

Atracurium

Intravenous atracurium

Intervention Type DRUG

ultrasound

ultrasound-guided block

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed A Ghanem, MD

Role: STUDY_DIRECTOR

Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Enas Abd Elmotlb, MD

Role: STUDY_CHAIR

professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt

Locations

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Mansoura University

Al Mansurah, DK, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed A Ghanem, MD'

Role: CONTACT

Phone: 00201067883998

Email: [email protected]

Enas Abd Elmotlb, MD

Role: CONTACT

Phone: 00201005401236

Email: [email protected]

Facility Contacts

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Mohamed A Ghanem, MD

Role: primary

Enas Abd Elmotlb, MD

Role: backup

Other Identifiers

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MD/ 21.04.462

Identifier Type: -

Identifier Source: org_study_id