跳至主要内容
临床试验/CTRI/2022/07/044245
CTRI/2022/07/044245尚未招募不适用

Effect of ropivacaine infiltration through pre-sternal multi-orifice catheter for post-sternotomy pain relief in adult patients undergoing cardiac surgery

LSNagaswetha1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2022年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
171
试验地点
1
主要终点
To evaluate the efficacy of ropivacaine infiltration by pre-sternal multi-orifice catheter for post-sternotomy pain relief in adult patients undergoing cardiac surgery based on Visual Analog Score (VAS) and rescue analgesic consumption.

研究概览

简要总结

Cardiac surgery induces severe postoperative pain, resulting in impairment of pulmonary function, increased duration of hospital stay with increased morbidity and mortality1. Inadequate pain control reduces the capacity to cough, mobility, increases the frequency of atelectasis and prolongs recovery2 . A major cause of pain after cardiac surgery is the median sternotomy particularly on the first two postoperative days2 . Sternotomy, rib retraction, conduit harvest and drain tubes are some of the sources of pain in cardiac surgery1 . The most often used analgesics in these patients are parenteral opioids which can lead to undesirable respiratory depression, nausea and vomiting2Therefore,  we  are  planning  a  prospective, randomised, controlled, study on the efficacy and safety of infusing long-acting local anaesthetic drugs vs intermittent boluses of local anaesthetic administration into the median sternotomy wound in adult  patients  after  cardiac  surgery. we hypothesized that this intermittent bolus administration of local anaesthetic would significantly improve pain control as that of continuous infusion, as evidenced by the reduced need for postoperative systemic analgesic

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •age groups 18-65 years of either sex
  • •category 1 or 2 under CARE score (Cardiac Anaesthesia Risk Evaluation score) are included in the study viz.
  • •coronary artery disease with TVD and normal LV function, all valve replacement surgeries, ASD and VSD closure.

排除标准

  • •emergency surgery
  • •Redo surgeries
  • •Preoperative inotropic support
  • •preoperative poor left ventricular function (EF <40%)
  • •clinically significant kidney or liver disease
  • •COPD patients, uncontrolled DM
  • •morbidly obese patients
  • •Low cardiac output syndrome
  • •patients allergic to local anaesthetics
  • •preexisting coagulopathy
  • •postoperative hemodynamic instability
  • •If surgeon refuses.

结局指标

主要结局

To evaluate the efficacy of ropivacaine infiltration by pre-sternal multi-orifice catheter for post-sternotomy pain relief in adult patients undergoing cardiac surgery based on Visual Analog Score (VAS) and rescue analgesic consumption.

时间窗: Visual analog scale assessment for 48hours

次要结局

  • Time to extubation ➢ Postoperative respiratory parameters ➢ Length of ICU stay ➢ Incidence of wound infection(171)

研究者

发起方
LSNagaswetha
申办方类型
Other [By principal investigator ]

研究点 (1)

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