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临床试验/CTRI/2023/09/057509
CTRI/2023/09/057509已完成4 期

Comparison of ultrasound guided transverse thoracic muscle plane block and pecto-intercostal fascial plane block in reducing post operative pain in pediatric cardiac surgeries via median sternotomies

Sree Chitra Tirunal Institute for Medical sciences and Technology1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年9月20日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
total opioid consumption in the first 24hours in both the groups

研究概览

简要总结

Pediatric cardiac surgery is associated with significant pain . Regional anesthesia helps in reducing intraoperative  and perioperative stress response and post operative  pain. This will reduce the total analgesia used and therefore help in early extubation .  We are trying to compare two types of parasternal blocks and its role in alleviating pain . Both the blocks are anterior parasternal block administered under ultrasound guidance . These blocks have been studied in adult patients and have been proven to have comparable results . These blocks are yet to be evaluated in pediatric population . In this study we propose  to assess the superiority of the 2 blocks.  The drugs used for the blocks are Bupivacaine and dexamethasone . The secondary objectives of this study include assessing pain in the post operative period , lactate and glucose levels.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

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

入选标准

  • Children with congenital heart disease with age more than 2yrs of age and less than 18yrs old 2) Children undergoing elective cardiac surgery through median sternotomy with cardiopulmonary bypass support 3) Children who are expected to be extubated with in 12hours after surgery.

排除标准

  • ) Emergency surgeries 2) Chest wall abnormalities 3) Subjects with known contraindication or allergy to local anesthetics 4) Evidence of coagulopathy 5) Infection at the site of planned block 6) RACHS-1 score more than or equal to
  • Patient shifted out to ICU with stented sternum or open chest.
  • Patient ventilated for more than 12hours after post op transfer to ICU 9) Severe PAH 10) Critically ill patient 11) Re-do surgeries.

结局指标

主要结局

total opioid consumption in the first 24hours in both the groups

时间窗: first 24hours

次要结局

  • 1.Comparing FLACC/NRS score during the first 24hours after administration of block. 2. Time to rescue analgesia in both the groups receiving ultrasound guided blocks. 3. Comparing the intraoperative analgesic requirement. 4. To study intraoperative & post operative stress response as assessed by glucose and lactate level and total duration of ICU stay(5. To study the procedure related complications)

研究者

发起方
Sree Chitra Tirunal Institute for Medical sciences and Technology
申办方类型
Research institution and hospital

研究点 (1)

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