跳至主要内容
临床试验/CTRI/2021/09/036938
CTRI/2021/09/036938招募中不适用

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

Department of Anaesthesiology1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月10日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Morphine Consumption – Total dose of morphine consumption

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •aged 18-80 years & ASA II-III.

排除标准

  • •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.

结局指标

主要结局

Morphine Consumption – Total dose of morphine consumption

时间窗: First and second postoperative day

次要结局

  • 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)

研究者

发起方
Department of Anaesthesiology
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验