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Completed

NCT Number: NCT05552417

Pectointercostal Block for Postoperative Pain Management After Sternotomy

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.

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Key information

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasralainy Faculty of Medicine

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pectointercostal facial plan block

Other

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

Other names: Pectointercostal facial nerve block

Primary outcomes

  1. Post-operative pain score

    Time frame: At 4 hours.

    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.

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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