A Combination of Intrathecal Fentanyl and Pecto-Intercostal Fascial Block in Paediatric Cardiac Surgery.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-6
SponsorAlexandria University
About this trial
Cardiac surgery is commonly performed via median sternotomy. Patients undergoing cardiac surgical procedures frequently experience intense acute pain in the post-sternotomy wound, which can potentially transition into persistent chronic pain in approximately 35% of cases after one year. Recently, thoracic myofascial plane blocks with ultrasound guidance as part of multimodal analgesia have contributed to a faster recovery after surgery.
De la Torre et al. first described pectointercostal fascial plane block (PIFPB) for breast surgery. Local anaesthetics are injected between the pectoralis major and internal intercostal muscles close to the sternum to block the anterior cutaneous branch of the second-to-sixth thoracic intercostal nerves.The use of intrathecal (IT) opioids with or without local anaesthetics (LA) is a popular analgesic technique around the world for the management of postoperative pain. Unlike IT administration of LA, IT opioids produce 'segmental' analgesia and are not associated with muscle weakness, loss of proprioception or sympathetic block. IT opioids can be administered as an adjunct to general anaesthesia or combined with LA and administered during spinal anaesthesia for surgery. It is one of the easiest, most reliable and cost-effective methods for pain relief. Intrathecal opioid administration can provide more intense analgesia than the IV route and has the advantages of simplicity and reliability
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The enrolled patients ranged in age from 6 months to 6 years,
patients scheduled for surgical repair of congenital heart defects.
Disqualifiers
The preoperative criteria include a history of previous cardiac surgery, hemodynamic instability, the need for mechanical ventilation, and the requirement for vasoactive drugs, opioids, or corticosteroids.
During the intraoperative phase, who use of deep hypothermic circulatory arrest and the necessity for vasoactive drugs, excluding the temporary use of dopamine and dobutamine at a maximum dose of 10 µg/kg/min.
Postoperative exclusion conditions will include prolonged mechanical ventilation lasting more than 24 hours, hemodynamic instability, and the need for high doses of opioids or sedatives.
Trial design
Design model
Parallel
Treatments tested in this trial
PIFB group
Procedure/SurgeryA pecto-intercostal-fascial plane block (PIFB) will be performed bilaterally in a supine position after induction of anaesthesia. The in-plane needle approach will be applied under the guidance of a high-frequency Hockey Stick Linear-Array US transducer probe (SONOSITE M-TURBO). Under strict aseptic precautions, the transducer will be placed 1-2 cm lateral to and parallel to the sternum to count the ribs from the second to the sixth rib. A 22-gauge, 50-mm short bevel echogenic needle will be advanced in a caudal-to-cranial direction until the tip of the needle will be in the targeted fascial plane, a test bolus of normal saline (1-2 mL) will be injected (in real-time) to confirm that the tip was correctly placed, as shown by separation of the fascial layers. After excluding intravascular, the dose of local anaesthetic (0.4 mL/kg 0.25% bupivacaine) will be deposited into the fascial plane visualised in real-time.
Intrathecal fentanyl(IT fentanyl)
Procedure/SurgeryIT fentanyl group (Group IT; n = 30) will be placed in lateral decubitus position immediately after intubation and catheterisation and receive an IT injection of 2 µg/kg of fentanyl in 0.2 mL/kg of normal saline through a 2-in., 25-gauge Quincke spinal needle inserted at L3-4 or L4-5. The dose of IT fentanyl will be based on a previous study. (15) with this route of fentanyl administration to provide intraoperative analgesia and blunt the stress response in pediatric cardiac anaesthesia. Successful dural puncture will be confirmed by observation of a free flow of cerebrospinal fluid, and the injection will be performed with the bevel of the needle oriented in the cephalic direction.
IT + PIFB
Procedure/SurgeryPatients assigned to the combined IT fentanyl and PIFB (Group IT + PIFB; n = 30) will receive both a PIFB and IT fentanyl, with the use of the methods described for the other two groups.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Pecto-Intercostal Fascial Block groupExperimental treatment 1 intervention
Group B: Intrathecal fentanyl groupActive comparator 1 intervention
Group C: intrathecal fentanyl and pectointercostal fascial blockActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
To investigate how effectively three distinct pain management techniques can reduce the stress response that patients experience after undergoing cardiac surgery.
Serum cortisol and plasma epinephrine and norepinephrine will be measured.
Time frame
after the procedure24 hourSecondary outcomes
1
To conduct a comparative analysis of the analgesic efficacy of each pain management method.
-Analgesia/sedation scores will be recorded The team will evaluate each child for the level of analgesia and sedation using the COMFORT scale. (16) (before extubation) and the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) (17) (after extubation)
Time frame
every 30 minutes for the first six postoperative hours and every 6 hours during the first, second, and third postoperative days.2
To meticulously document and evaluate any potential adverse effects associated with these pain management strategies, ensuring patient safety.
The incidence of adverse events associated with the block is as follows: local anaesthesia toxicity (neurologic or cardiovascular events occurring within the first 30 min after block administration), chest wall hematoma, and pneumothorax (diagnosed by the US after block and before skin incision).
Time frame
first 30 min after block administration and 24 hour postoperatively3
to determine which technique offers the most effective in early extubation
The time to extubate (in minutes )
Time frame
in first 24 hour postoperatively4
to determine the duration of analgesic effect of technique post operative
The time for first rescue analgesia in minutes
Time frame
in first 24 hour postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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