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临床试验/NCT05590026
NCT05590026招募中4 期

Pediatric Pectointercostal and ESP Block in Cardiac Surgery Surgery

Cukurova University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Postoperative analgesia

研究概览

简要总结

American Society of Anaesthesiologist physical status II-III, aged between 2, 12 patients which underwent open cardiac surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the all patient under general anaesthesia. Totally bupivacaine %0.25 2.5 mg/kg will use blocks. 2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine will apply intravenously at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores

详细描述

American Society of Anaesthesiologist physical status II-III, aged between 2-12, 60 patients which underwent open cardiac surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T6 level (bilaterally) and pectointercostal plane block at 4-5 intercostal space to the 30 patients under general anaesthesia in Group block and block will not perform to the control group. Sevoflurane+remifentanil and O2/air combination will perform to the all patients during the surgery. Totally bupivacaine %0.25 2.5 mg/kg will use for blocks.2 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery. 0.1 microgram/kg morphine intravenously will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain and agitation assessment will perform with FLACC and Watcha scores. FLACC, Watcha scores, morphine consumption and complications will record.Paracetamol 10 mg/kg will repeat to the all patients at the 12th of postoperative period, intravenously. The patient controlled anesthesia with morphin will apply to the all patients. If the FLACC score is higher than 4, morphine 0.015 mg/kg will administer intravenously.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Ages between 2-12 years
  • ASA II-III children
  • The children who undergoing open heart surgery

排除标准

  • Coagulopaty
  • Allergy of local anesthetic
  • Liver and renal failure
  • Obesity (BMI >35kg/m2)
  • Infection at the block area

研究组 & 干预措施

Pectointercostal and ESP block

Active Comparator

Pectointercostal and ESP block will apply to the children after intubation. Totally bupivacain %0.25, 2.5 mg/kg will apply.

干预措施: Pectointercostal and ESP block (Drug)

No Block

Placebo Comparator

No block will apply to the patient

干预措施: Pectointercostal and ESP block (Drug)

结局指标

主要结局

Postoperative analgesia

时间窗: 24 hours in Postanesthesia care unit (PACU)

Postoperative analgesia will asses Face, Legs, Activity, Cry, Consolability (FLACC) score in (Postanesthesia care unit) PACU till the 24th hours postoperatively. FLACC score reflects pain score between 0-10. 0 means zero pain, 10 means worse pain score

Postoperative morphine consumption

时间窗: 24 hours in Postanesthesia care unit (PACU)

Postoperative morphine consumption will record till the postoperative 24 th hours

次要结局

  • Postoperative agitation(First 24 hours at Postanesthesia care unit (PACU))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ebru biricik

Associate Professor

Cukurova University

研究点 (1)

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