Comparison of ultrasound-guided erector spinae plane block vs. midpoint transverse process to pleura block for perioperative analgesia in paediatric cardiac surgery by open sternotomy approach: A randomized comparative study.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Raja Avinash
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- 1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation
Overview
Brief Summary
This study is conducted to compare the a perioperative analgesic effect of two USG-guided intervantions named B/L MTP block and B/L ESP block. Each group has 35 patients, ranging in age from 1 to 10 years old, who are scheduled for cardiac surgery via an open sternotomy approach. We use 0.25% bupivacaine hydrochloride at 0.3 ml/kg in both groups. A skilled anesthesiologist will inject the liquid by using a 22-gauge, 5-cm echogenic needle at a level of 4-5 thoracic vertebrae. A comfort scale-based pain assessment will be performed at skin incision, sternotomy, weaning from bypass, 0 hr of shifting to ICU, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, and at extubation. total fentanyl consumption in 24 hours is also noted
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients undergoing elective cardiac surgical procedure via median sternotomy incision.
Exclusion Criteria
- •Complex cardiac anomalies, including atrioventricular septal defect, coarctation of the aorta, severe stenosis or insufficiency of the semilunar valves and Tetralogy of Fallot 2) Local site infection 3) Systemic sepsis 4) History of allergy to local anaesthetic agent 5) Liver dysfunction 6) Redo surgery/Emergency surgery 7) Critically ill patient viz on mechanical ventilation, preoperative inotropic support 8) Thoracic vertebral abnormalities 9) Intraoperative and postoperative complications related to surgery or nature of the disease e.g., Intra-operative pulmonary hypertensive crisis, difficult CPB weaning, need for prolonged elective ventilation post-op.
- •Pre-existing coagulopathic disorder.
- •Parent refusal to consent and participation.
Outcomes
Primary Outcomes
1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation
Time Frame: 1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation
Secondary Outcomes
- . Mean fentanyl consumption intraoperative and post-operative(2. Rescue analgesia requirement)
Investigators
RAJA AVINASH
ABVIMS, Dr RML Hospital, New Delhi