Efficacy of bilateral parasternal subpectoral catheters(sternal block)for postoperative analgesia following sternotomy-A randomized double blinded cross over clinical trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Morphine Consumption – Total dose of morphine consumption
Study Overview
Brief Summary
Patients undergoing elective cardiac surgical procedures through median sternotomy at MGMCRI ,after obtaining ethical committee approval and informed consent from patients , will receive General anaesthesia with invasive monitoring according to discretion of attending anaesthesiologist. The Inclusion criteria include patients aged 18-80 years & ASA II-III .Exclusion criteria includes patients -redo Sternotomy, requiring higher inotropic support and prolonged ventilatory support, difficult to wean from CPB, contraindications for local anesthetics and unable to comprehend VAS score. 30 patients (15 per group) satisfying inclusion and exclusion criteria will be recruited by continuous sampling and Bilateral parasternal sub pectoral catheter will be inserted under ultrasound guidance after skin closure.Group A (15 patients) will receive 10 ml of Local anaesthesia on POD 1 ,10 ml of NS on POD 2 .Group B 15 patients will receive 10 ml of NS on POD 1 ,10 ml ofLocal anaesthesia on POD 2 .Study Parameters will be assessed on 9am 1pm 6pm 10pm on POD 1 and POD 2 .
· Efficacy of Pain relief: Static and dynamic NRS, Rescue analgesic consumption, Patient satisfaction score.
· Functional outcome of pain relief: Quality of cough, PEFR, No. of balls lifted during spirometry
· Complications: Sedation, LAST, wound infection, nausea, vomiting
Rescue analgesics will be provided if NRS >5
(1)Inj Ketorolac 30 mg iv with minimum interval of 4 hour between doses and max 90 mg
(2) Inj Morphine after 20 minutes of Ketorolac- 3 mg with minimum 15 minutes between doses and a maximum of 9 mg /day
All patients Patients will be shifted to CTVS ICU for overnight elective ventilation. On POD 1 6am study regimen will be injected and repeated 6th hourly till 48 hrs.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •aged 18-80 years & ASA II-III.
Exclusion Criteria
- •redo Sternotomy, requiring higher inotropic support and prolonged ventilatory support, difficult to wean from CPB, contraindications for local anesthetics and unable to comprehend VAS score.
Outcomes
Primary Outcomes
Morphine Consumption – Total dose of morphine consumption
Time Frame: First and second postoperative day
Secondary Outcomes
- 2.Efficacy of Pain relief(a.Cumulative dosage of rescue analgesic)
- 3.Functional outcome of pain relief(a.Quality of Cough)
- 4.Complications(First and second postoperative day)
