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临床试验/NCT05590013
NCT05590013招募中4 期

Determining to the Effect of Pectointercostal and ESP Block on Postoperative Analgesia During Open Heart 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11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 18-65, 60 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 and 1 ml epinephrin will add to the each local anesthetic solutions. 10 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 assessment will perform with visual analog scale (VAS)

详细描述

American Society of Anaesthesiologist physical status II-III, aged between 18-65, 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 and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 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 assessment will perform with visual analog scale (VAS). VAS, 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 VAS score is higher than 4, the rescue analgesic diclofenac Na 75 mg 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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA II-III patients
  • The patients who will operate for open heart surgery

排除标准

  • The patients with Coagulopaty
  • Allergy with local anesthetics
  • infection at the injection sites
  • Obesity (BMI >35kg/m2)
  • Liver and/or kidney failure

研究组 & 干预措施

Pectointercostal and ESP

Active Comparator

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 . 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 and 1 ml epinephrin will add to the each local anesthetic solutions in each side.10 ml %0.25 bupivacain will apply to the chest tube area at the end of surgery.

干预措施: Pectointercostal and ESP block (Drug)

Control Group

Placebo Comparator

Block will not perform to the control group.

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)

Visual analog scale (VAS) scores at the postoperative 24th hours. VAS scores define pain scores between 0-10. 0 reflects nopain, 10 reflects the worst pain.

Morphine consumption

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

Postoperative morphine consumption during the postoperative 24th hours

次要结局

  • Ekstübation time(First 6 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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