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Clinical Trials/CTRI/2021/09/036938
CTRI/2021/09/036938RecruitingNot Applicable

Efficacy of bilateral parasternal subpectoral catheters(sternal block)for postoperative analgesia following sternotomy-A randomized double blinded cross over clinical trial

Department of Anaesthesiology1 site in 1 country30 target enrollmentStarted: January 10, 2021Last updated:

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)

Investigators

Sponsor
Department of Anaesthesiology
Sponsor Class
Research institution and hospital

Study Sites (1)

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