Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery
Ultrasound-Guided Bilateral Pecto-intercostal Fascial Block Versus Intravenous Fentanyl for Postoperative Pain Management After Pediatric Cardiac Surgery A Prospective, Randomized, Controlled Study
1 other identifier
interventional
80
1 country
1
Brief Summary
Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site. In pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children. Pectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2021
CompletedFirst Posted
Study publicly available on registry
June 30, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 30, 2021
June 1, 2021
6 months
June 13, 2021
June 22, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Postoperative pain assessment
Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.
Postoperative day 1
Total dose of fentanyl requirements
Total dose of fentanyl requirements
intraoperative and 24 hrs postoperatively
Secondary Outcomes (3)
Serum cortisol levels
Basal and one-hour postoperatively
Heart rate [HR]
before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Invasive mean arterial blood pressure [MAP]
before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum
Study Arms (2)
Ultrasound-guided bilateral pecto-intercostal fascial block
EXPERIMENTALPatients will receive bilateral ultrasound-guided pecto-intercostal fascial block
Intravenous fentanyl
PLACEBO COMPARATORPatients will receive only incremental doses of intravenous fentanyl
Interventions
\- PATIENT IN SUPINE POSITION, SKIN WILL BE DISINFECTED, A HIGH-FREQUENCY LINEAR PROBE WILL BE PLACED PARALLEL TO LONGITUDINAL AXIS OF STERNUM ON LATERAL BORDER AND SCANNED LATERALLY TO IDENTIFY 4TH AND 5TH COSTAL CARTILAGE. THE PECTORALIS MAJOR MUSCLE (PMM), INTERNAL INTERCOSTAL MUSCLE (IIM), TRANSVERSUS THORACIS MUSCLE (TTM), RIBS, AND PLEURA WILL BE IDENTIFIED. COLOR DOPPLER ULTRASONOGRAPHY WILL BE USED TO DETERMINE PERFORATING BRANCHES OF INTERNAL THORACIC ARTERY, WHICH TRAVEL ANTERIORLY THROUGH THE ANTERIOR CHEST WALL, PIERCING THE INTERCOSTAL MUSCLE AND PMM. A 22G NEEDLE WILL BE INSERTED IN PLANE WITH PROBE, IN CAUDAL-TO-CRANIAL DIRECTION UNTIL THE TIP IS POSITIONED IN INTER- FASCIAL PLANE BETWEEN THE PMM AND IIM. NORMAL SALINE WILL BE USED TO DETERMINE CORRECT PLACEMENT OF NEEDLE TIP IN INTER-FASCIAL PLANE, AS SHOWN BY SEPARATION OF FASCIAL LAYERS THEN LOCAL ANESTHETIC WILL BE INJECTED
In this group, patients will receive only incremental doses of intravenous fentanyl
Propofol anesthesia
Sevoflurane anesthesia
Intravenous atracurium
Eligibility Criteria
You may qualify if:
- On pump
- Elective repair of congenital simple left to right intracardiac shunt
- Median sternotomy
You may not qualify if:
- Refusal of their guardians
- Redo cardiac surgery
- Previous back injury
- Previous back surgery
- Kyphoscoliosis
- Local infection of the skin and subcutaneous tissue at the site of needle puncture
- Hypersensitivity to local anesthetics
- Coagulation disorders
- Renal disease
- Hepatic disease
- Pulmonary disease
- Heart failure
- Moderate to severe pulmonary hypertension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University
Al Mansurah, DK, 050, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohamed A Ghanem, MD
Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
- STUDY CHAIR
Enas Abd Elmotlb, MD
professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2021
First Posted
June 30, 2021
Study Start
August 1, 2021
Primary Completion
February 1, 2022
Study Completion
August 1, 2022
Last Updated
June 30, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- will be available within 6 months of study completion
- Access Criteria
- data access requests will be reviewed by an external independent review panel .requestors will be required to sign a data access agreement
De -identified individual participant data for all primary and secondary outcome measures will be made available