- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05552417
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt
- Recruiting
- Kasralainy Faculty of Medicine
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Contact:
- Ahmed Mohamed Elhaddad, MD
- Phone Number: 01224042847
- Email: drblacksmith5@kasralainy.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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At 4 hours.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N-92-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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