About this trial
In this study we are aiming to compare the Erector Spinae Plane Block and the Deep Parasternal intercostal plane block as regard to their technique, application and outcome in order to describe the most suitable method for pediatric cardiac patients undergoing primary repair of septal defects
The primary outcome of this study will be the time of the first request for postoperative analgesics by FLACC pain scale more than 4 The secondary outcomes will be the total postoperative analgesic consumption, time for extubation, the incidence of nausea and vomiting, hemodynamic instability, onset of ambulation and any other complications on the first day after surgery
Participants will be enrolled in this double-blinded randomly allocated using computer-based randomization into three groups. Group 1 will receive bilateral deep parasternal intercostal plane block. Group 2 will receive bilateral erector spinae plane block. Group 3 will receive conventional analgesic regimen without having a regional block
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients with acyanotic heart disease
Patients with septal defect undergoing primary repair
ASA Ⅰ and Ⅱ
Disqualifiers
Patient's guardian refusal of procedure or participation in the study.
Patients with hemodynamic instability
Preexisting infection at the block site
Allergy to local anesthetics
Trial design
Parallel
Treatments tested in this trial
Deep Parasternal intercostal plane block
Procedure/SurgeryPatients will receive bilateral deep parasternal plane block using, 1mg/kg of 0.25% bupivacaine on each side under ultrasound guidance. The total dose of bupivacaine amounting to 2 mg/kg.
Erector Spinae Plane Block
Procedure/SurgeryPatients will receive bilateral erector spinae plane block using, 1 mg/kg of 0.25% bupivacaine will be administered on each side under ultrasound guidance. The total dose of bupivacaine amounted to 2 mg/kg
conventional analgesic regimen
DrugAnesthesia will be induced with IV ketamine, 2 mg/kg, fentanyl, 2 µg/kg, and rocuronium 0.9 mg/kg, administered to facilitate endotracheal intubation. Maintenance of anesthesia will be achieved by isoflurane at an end tidal concentration of 1-1.5% in FiO2 of 0.5, intravenous fentanyl at a dose of 1 µg/kg in incremental dosage, and intravenous rocuronium 0.15 mg/kg administration according to nerve stimulator.
Treatment groups
Trial outcomes
Primary outcomes
Time of the first request for postoperative analgesics
The time of the first request for postoperative analgesics by Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale more than 4. Patients will be assessed at 0, ½, 1, 2, 4, 6, 8, 12, 24 hours.
Secondary outcomes
Total postoperative analgesic consumption.
Comparison between the three groups considering the amount of opioids consumed according to FLACC scale in the post operative period.
Time for extubation
Comparison between the three groups considering the effect of different pain control modalities on aiding fast track extubation.
Incidence of nausea
Comparison between the three groups considering the effect of different pain control modalities on the incidence of nausea and vomiting, either by a direct central effect or indirectly due to pain.
Hemodynamic instability
Comparison between the three groups considering the incidence of hemodynamic instability due to the effect of local anesthetics on hemodynamics or the depressor effect of opioids on the first hours after surgery. Also, the surgical causes of hemodynamic instability in the first day and its effect on the study.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: