Pectointercostal Block for Postoperative Pain Management After Sternotomy
Primary Purpose
Post Operative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pectointercostal facial plan block
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
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.
Sites / Locations
- Kasralainy Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
control group
Pectointercostal
Arm Description
Conventional control group(C) (n=--) where --- children will not receive any intervention.
Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05552417
First Posted
September 20, 2022
Last Updated
September 23, 2022
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05552417
Brief Title
Pectointercostal Block for Postoperative Pain Management After Sternotomy
Official Title
Efficacy of Pectointercostal Facial Nerve Block for Postoperative Pain Management After Sternotomy in Pediatric Open Cardiac Surgery:A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Conventional control group(C) (n=--) where --- children will not receive any intervention.
Arm Title
Pectointercostal
Arm Type
Active Comparator
Arm Description
Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.
Intervention Type
Other
Intervention Name(s)
Pectointercostal facial plan block
Other Intervention Name(s)
Pectointercostal facial nerve block
Intervention Description
Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.
Primary Outcome Measure Information:
Title
Post-operative pain score
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kasralainy Faculty of Medicine
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Elhaddad, MD
Phone
01224042847
Email
drblacksmith5@kasralainy.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Pectointercostal Block for Postoperative Pain Management After Sternotomy
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