A comparative study on the analgesic efficacy of ultrasound-guided bilateral pecto-intercostal fascial block with an ultrasound guided caudal block in pediatric patients undergoing congenital cardiac surgeries- A randomised double blind study.
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Sri Padmavathi children heart centre TTD
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation
Overview
Brief Summary
There are no studies done on the effectiveness of ultrasound-guided caudal block and comparing it with ultrasound-guided Pecto-intercosto fascial block in pediatric cardiac surgical patients. Hence, we propose to compare the analgesic efficacy of U/S guided PIFB and caudal epidural block in children undergoing open heart surgery through a median sternotomy approach.
The primary outcome measure was to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation within 12 hour between U/S guided PIFB versus U/S guided caudal block. The secondary outcome measure will be to assess pain scores in the postoperative period post exubation within 12 hours, duration of mechanical ventilation and the incidence of adverse effects between U/S guided PIFB versus U/S guided caudal block.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 6.00 Month(s) to 7.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients in the age group 6 months -7 years of age undergoing elective congenital cardiac surgery requiring median sternotomy and CPB will be included in the study.
Exclusion Criteria
- •Patients with RACHS (Risk Adjusted classification for Congenital Heart Surgery) score > 3 b.
- •Emergency surgeries c.
- •Chest wall deformities d.
- •Anorectal malformations e.
- •Subjects allergic to local anaesthetics f.
- •Evidence of Coagulopathy g.
- •Patients on anticoagulants h.
- •Localized infection.
Outcomes
Primary Outcomes
to assess additional fentanyl consumption in the intraoperative and postoperative period after extubation
Time Frame: Within 12hours after extubation
Secondary Outcomes
- To assess pain scores in the postoperative period post extubation, duration of mechanical ventilation and the incidence of adverse effects(Within 12hours)
Investigators
Joshna valaji
Sri Padmavathi children heart centre, SVIMS university.