Pectointercostal Block for Postoperative Pain Management After Sternotomy

NCT ID: NCT05552417

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-03-01

Brief Summary

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.

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

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control group

Conventional control group(C) (n=--) where --- children will not receive any intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pectointercostal

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

Group Type: ACTIVE_COMPARATOR

Pectointercostal facial plan block

Intervention Type: OTHER

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

Interventions

Pectointercostal facial plan block

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

Intervention Type: OTHER

Other Intervention Names

Pectointercostal facial nerve block

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Mohamed Elhaddad

Lecturer of Anesthesia, ICU and Pain managment

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kasralainy Faculty of Medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-92-2022

Identifier Type: -

Identifier Source: org_study_id