Deep Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Cardiac Patients Undergoing Primary Repair of Septal Defects Via Median Sternotomy

ConditionSeptal Defect
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-10
SponsorAin Shams University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Deep Parasternal intercostal plane block

    Procedure/Surgery

    Patients 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/Surgery

    Patients 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

    Drug

    Anesthesia 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

45 Participants
are divided into 3 treatment groups
Group A: Deep Parasternal Intercostal Plane BlockActive comparator 1 intervention
Group B: Erector Spinae plane blockActive comparator 1 intervention
Group C: conventional analgesic regimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

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 frame
24 hours
2

Time for extubation

Comparison between the three groups considering the effect of different pain control modalities on aiding fast track extubation.

Time frame
24 hours
3

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.

Time frame
24 hours
4

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.

Time frame
24 hours

Other outcomes

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: