ULTRASOUND GUIDED PARASTERNAL MODIFIED INTERCOSTAL NERVE BLOCK: ROLE AS A PREEMPTIVE ANALGESIC ADJUNT IN FAST TRACKING FOR MITIGATING POSTOPERATIVE STERNOTOMY PAIN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- SCTIMST
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Quality and effectiveness of pain relief will beevaluated for 48 hrs after the surgery with routine in-hospital analgesic protocol using following parameters:
研究概览
简要总结
Design: Prospective, Double Blinded Intervention study Setting: A tertiary referral centre, a universityhospital and single-centre (SCTIMST).
90 Patients comingfor elective CABG surgery will be randomized into two groups and a ultrasoundguided parasternal modified intercostal nerve block will be performed eitherwith 0.5%levobupivacaine or saline. All other routine standard anaesthetic andanalgesic protocols will be followed intraoperatively and postoperatively.
Objective of the study would be to do
1. To assess the quality andeffectiveness of postoperative pain relief offered by ultrasound guided singleshot Parasternal modified-intercostal nerve block after tracheal extubation,when the block would be administered before surgical incision providingpreemptive analgesia.
2. Effects of the blockade onsedation, ventilation and requirement of concomitant analgesics
To assess the patient cooperation and patientcomfort while performing the deep inspiratory exercises, coughing, andincentive spirometry, in the immediate post Tracheal-extubation and period unto48 Hrs. post-surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •CABG 40-70 YRS.
排除标准
- •Emergency Surgeries.
- •Redo-surgeries.
- •Open Sternum Left Ventricular Ejection Fraction < 35% Preoperative use of narcotics or illicit drug abuse.
- •History of chronic intractable non-cardiac pain.
- •Liver or Kidney disease Allergy to Amide group of anaesthetics, Morphine or Fentanyl.
- •Arrhythmia history or rhythm disturbances documented in ECG.
- •Haemodynamically unstable patients already on preoperative inotropic support or Intra-arterial balloon pumps (IABP).
- •Anticipated surgery or surgery lasting more than 6hrs.
- •Intubation time more than 12hrs or planned for overnight ventilation.
- •Patients refusing to participate.
- •Patients refusing the offered therapeutic options in either group.
- •Patients refusing for parting with medical data for analysis.
- •Patients refusing to participate after the start of study and desire to leave the study at any point of time.
- •Patients currently enrolled in another study.
- •Inability to complete Pain assessments.
- •Post-operative complications with underlying cardio-respiratory cause requiring return to operative room for re-explorations or reinstitution of mechanical ventilation.
结局指标
主要结局
Quality and effectiveness of pain relief will beevaluated for 48 hrs after the surgery with routine in-hospital analgesic protocol using following parameters:
时间窗: Quality and effectiveness of pain relief will beevaluated for 48 hrs after the surgery with routine in-hospital analgesic protocol using following parameters: | 11-point 0-10 Verbal Numeric RatingEffects of the blockade on sedation, ventilation and requirement of concomitant analgesics will be assessed using following methods: | a) Alertness of patients in peri-tracheal extubation period, as assessed by Ramsay Sedation score in the initial 48 hours after the block.
11-point 0-10 Verbal Numeric RatingEffects of the blockade on sedation, ventilation and requirement of concomitant analgesics will be assessed using following methods:
时间窗: Quality and effectiveness of pain relief will beevaluated for 48 hrs after the surgery with routine in-hospital analgesic protocol using following parameters: | 11-point 0-10 Verbal Numeric RatingEffects of the blockade on sedation, ventilation and requirement of concomitant analgesics will be assessed using following methods: | a) Alertness of patients in peri-tracheal extubation period, as assessed by Ramsay Sedation score in the initial 48 hours after the block.
a) Alertness of patients in peri-tracheal extubation period, as assessed by Ramsay Sedation score in the initial 48 hours after the block.
时间窗: Quality and effectiveness of pain relief will beevaluated for 48 hrs after the surgery with routine in-hospital analgesic protocol using following parameters: | 11-point 0-10 Verbal Numeric RatingEffects of the blockade on sedation, ventilation and requirement of concomitant analgesics will be assessed using following methods: | a) Alertness of patients in peri-tracheal extubation period, as assessed by Ramsay Sedation score in the initial 48 hours after the block.
次要结局
- 1.Over-sedation leading to ETCO2 or PaCO2 build up during the ventilator weaning phase or peri-tracheal extubation period(2.Any requirement for temporary discontinuation of opioid infusion.)