Pectointercostal Block for Postoperative Pain Management After Sternotomy

Efficacy of Pectointercostal Facial Nerve Block for Postoperative Pain Management After Sternotomy in Pediatric Open Cardiac Surgery:A Randomized Controlled Trial

This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound-guided bilateral pectointercostal facial block in children undergoing cardiac surgery via midline sternotomy.

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Pectointercostal facial plan block

Detailed Description

Following approval from the research and ethics committee ,preoprrative preparation, and induction of anesthesia The patient will be assigned to two equal groups. Conventional control group(C) (n=30) where --- children will not receive any intervention.

Pectointercostal facial group (PI) (n=30) where --children will have bilateral Pectointercostal Block.

Patient positioning and preparation for Ultrasound-guided PIFB After skin disinfection, the PIFB will be performed in a supine position using a high-frequency (6-13 MHz) linear ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA). The probe will be placed at 2 cm lateral from the sternum and parallel to the sternum and will be scanned laterally to identify 4th and 5th costal cartilage The pecto-intercostal fascial plane will be located between the pectoralis major muscle and the external intercostal muscle or the costal cartilage. A 22G, 50 mm peripheral block needle, Stimuplex® Ultra 360 (B. Braun, Melsungen, Germany) will be placed under the pectoralis major and above the external intercostal muscle with an in-plane approach with the ultrasound probe, in a caudal-to-cranial direction until the tip is positioned in the interfascial plane between the PMM and IIM .

A test bolus of saline (1 mL) will be injected to determine that the tip has been placed in the correct fascial layers. Finally, 1.5 mg/kg of 0.2% bupivacaine will be injected into this plane in two locations, over the 2nd and 4th rib. The method on the other side of the PIFB will be the same Care will be taken not to cross the toxic dose of bupivacaine (3 mg/kg). (6) .

Heart rate, mean arterial pressure, and oxygen saturation will be monitored continuously.

After completion of the surgery, inhalational anesthetics will be stopped as well as the muscle relaxant.

The patient will be then transferred to the ICU.Postoperative assessment and analgesic regimen: An IV Paracetamol 15 mg / kg will be given and will be repeated every 8 hours .The Face, Legs, Activity, Cry, Consolability scale (FLACC) (table 1) will be assessed in the PICU and every 4 hours for 24 hours. The time to the first request of rescue postoperative analgesic will be: "the time interval between the onset of block and the first request to postoperative analgesia". When patients first complain of pain (FLACC score ≥4) rescue analgesia will be given in the form of incremental intravenous morphine

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Kasralainy Faculty of Medicine
    • Contact: Ahmed Mohamed Elhaddad, MD; Phone Number: 01224042847; Email: drblacksmith5@kasralainy.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 6 to 36 months
• sex both
• Weight > 5kg
• Pathology A-V canal , ASD closure, VSD closure surgery through a midline sternotomy.

Exclusion Criteria:

• Redo patient.
• History of allergic reactions to local anesthetics.
• Bleeding disorders with INR > 1.5 and/or platelets < 50 000.
• Rash or signs of infection at the injection site.
• Emergency procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Conventional control group(C) (n=--) where --- children will not receive any intervention.
Active Comparator: Pectointercostal; Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.	Other: Pectointercostal facial plan block; Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.; Other Names: Pectointercostal facial nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain score	Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable,1-3:Mild discomfort,4-6:Moderate discomfort, &7-10:Sever discomfort ) (FLACC) scale pain score at 4 hours.	At 4 hours.

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: N-92-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No