An interventional study of Pectointercostal facial plan block in Post Operative Pain, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 6 Months to 36 Months. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Kasr El Aini Hospital · Not applicable, Interventional, and Treatment
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.
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
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Conventional control group(C) (n=--) where --- children will not receive any intervention.
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.
Also known as: Pectointercostal facial nerve block
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.
Time frame: At 4 hours.
Plan to share: Undecided
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Kasr El Aini Hospital