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临床试验/CTRI/2024/06/068774
CTRI/2024/06/068774尚未招募2 期

A Randomized Controlled Study for The Efficacy Of Parasternal Intercostal Block For Perioperative Analgesia In Cardiac Surgery at SMS Hospital, Jaipur

Sawai Mansingh Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
To assess the difference in opioid requirement during cardiac surgery between the two group

研究概览

简要总结

After obtaining approval from the institutional ethics committee and written informed consent patients scheduled for heart valve replacement surgery under general anaesthesia satisfying inclusion criteria will be enrolled in this study, NBM status, PAC consent will be checked in the operating room. Patient will be given T. Alprex 0.5mg   previous night.

Routine vital monitors will be attached for ECG, SpO2; EtCO2,entropy. Peripheral IV line, IJV central line ,arterial line for invasive BP monitoring secured and vitals (HR,SBP,DBP,CVP) will be noted before induction . After randomization, patients  (n=80) will be allocated into specific group as per study protocol by sealed  envelope method. Patient will be induced with Inj.Midazolam 0.05mg/kg and Inj.Fentanyl 4microgram/kg, Inj. Etomidate 0.3mg/kg, Inj. Rocuronium 0.9mg/kg to facilitate tracheal intubation. Patient will be mechanically ventilated by 100% O2 with tidal volume 6-8ml/kg.EtCo2 35-45mm Hg will be maintained by adjusting respiratory rate of 12-16 breathe per minute.

In Parasternal intercostal group, Group A, patients  will receive bilateral USG guided parasternal Intercostal block immediately after induction of general  anaesthesia  and intubation. The block will be excecuted with aseptic technique.The block will be given between the pectoral major and the intercostal muscles, proximal to the sternum from 2nd to 6th intercostal spaces..

with 40ml of 0.5% ropivacaine  plus 25 microgram fentanyl  (4ml in each space from 2nd to 6th intercostal space on each side) before incision and local infiltration of 10ml of 0.5%  ropivacaine  on  surgical drainage sites at the end of the surgery.

                                                                                                                                                  In Controlled group: Patients undergoing cardiac surgery under GA will receive only local infiltration of surgical drainage site at the end of the surgery. Hemodynamic parameters and fentanyl requirement will be assessed intraoperatively as per BIS.

In both the groups, patients will be shifted to ICU after surgery with ETT in situ.

In both the groups, IV fentanyl (25 µg/ml) at a basal infusion rate of 1ml/hour and a bolus of 1ml (fentanyl 25µg) given by the patient him/herself whenever needed with a lockout interval of 15 minutes for 48 hrs hours after extubation. If the patient will still experience pain ( VAS>= 4), then Inj tramadol 50mg will be given.

Hemodynamic parameters, fentanyl requirement , VAS score and pulmonary function( PEFR by wright’s peak flow meter) will be assessed immediately,2, 4, 6,12,18,24,30,36,42 and 48 hr post extubation. Side effects or complications if any will also be noted. End point of the study will be 48hrs after extubation.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1 Patient giving informed written consent 2 All patients between the age group 18-60 years of age scheduled for planned cardiac surgery.
  • 3 ASA grade II & III.

排除标准

  • 1 Skin infection at the puncture site.
  • 2 Allergy to local anaesthetics.

结局指标

主要结局

To assess the difference in opioid requirement during cardiac surgery between the two group

时间窗: assessed immediately,2, 4, 6,12,18,24,30,36,42 and 48 hr post extubation.

To assess the difference in post operative VAS between the two groups

时间窗: assessed immediately,2, 4, 6,12,18,24,30,36,42 and 48 hr post extubation.

次要结局

  • To assess the difference in Haemodynamic stability between two groups(To assess the difference in total opioid requirement in 48 hrsTo assess the difference in Haemodynamic stability between two groups)

研究者

发起方
Sawai Mansingh Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Reema Meena

Sawai Mansingh Medical College and Hospital,Jaipur

研究点 (1)

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