跳至主要内容
临床试验/CTRI/2024/03/063523
CTRI/2024/03/063523
尚未招募
不适用

Comparison of ultrasound-guided erector spinae plane block vs. midpoint transverse process to pleura block for perioperative analgesia in paediatric cardiac surgery by open sternotomy approach: A randomized comparative study.

Raja Avinash1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年3月11日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Raja Avinash
入组人数
70
试验地点
1
主要终点
1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation

概览

简要总结

This study is conducted to compare the a perioperative analgesic effect of two USG-guided intervantions named B/L MTP block and B/L ESP block. Each group has 35 patients, ranging in age from 1 to 10 years old, who are scheduled for cardiac surgery via an open sternotomy approach. We use 0.25% bupivacaine hydrochloride at 0.3 ml/kg in both groups. A skilled anesthesiologist will inject the liquid by using a 22-gauge, 5-cm echogenic needle at a level of 4-5 thoracic vertebrae. A comfort scale-based pain assessment will be performed at skin incision, sternotomy, weaning from bypass, 0 hr of shifting to ICU, 2 hr, 4 hr, 6 hr, 8 hr, 12 hr, 24 hr, and at extubation. total fentanyl consumption in 24 hours is also noted

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
1.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing elective cardiac surgical procedure via median sternotomy incision.

排除标准

  • Complex cardiac anomalies, including atrioventricular septal defect, coarctation of the aorta, severe stenosis or insufficiency of the semilunar valves and Tetralogy of Fallot 2) Local site infection 3) Systemic sepsis 4) History of allergy to local anaesthetic agent 5) Liver dysfunction 6) Redo surgery/Emergency surgery 7) Critically ill patient viz on mechanical ventilation, preoperative inotropic support 8) Thoracic vertebral abnormalities 9) Intraoperative and postoperative complications related to surgery or nature of the disease e.g., Intra-operative pulmonary hypertensive crisis, difficult CPB weaning, need for prolonged elective ventilation post-op.
  • Pre-existing coagulopathic disorder.
  • Parent refusal to consent and participation.

结局指标

主要结局

1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation

时间窗: 1.Perioperative pain, which is measured using the Comfort Scale at skin incision, sternotomy, weaning from bypass, at 0 1, 2, 4, 6, 8, 12, 24 hours after shifting to Intensive care unit, and at extubation

次要结局

  • . Mean fentanyl consumption intraoperative and post-operative(2. Rescue analgesia requirement)

研究者

发起方
Raja Avinash
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

RAJA AVINASH

ABVIMS, Dr RML Hospital, New Delhi

研究点 (1)

Loading locations...

相似试验