跳至主要内容
临床试验/NCT05627869
NCT05627869招募中不适用

Comparison of Effects of Transversus Thoracic Muscle Plane Block vs Pecto-intercostal Fascial Block on Postoperative Opioid Consumption in Patients Undergoing Open Cardiac Surgery: A Prospective Randomized Study

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
The primary outcome will be total morphine consumption

研究概览

简要总结

The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.

详细描述

Cardiac surgery performed through median sternotomy is associated with significant postoperative pain.Poststernotomy pain leads to decreased patient satisfaction, delirium, cardiovascular complications (hypertension, tachycardia, arrhythmias), hyperglycemia and respiratory complications (bronchial secretion stasis, atelectasis and pneumonia).High-dose opioids can provide good postoperative analgesia for patients undergoing heart surgery. However, opioids have some side effects.The advent of ultrasound-guided regional anaesthesia led to the development of fascial plane chest wall block as transthoracic plane block and pectointercostal fascial block.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 75 years.
  • Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.
  • American Society of Anesthesiologists classification of physical status < IV.

排除标准

  • Emergency surgery.
  • Off-pump surgery.
  • Redo surgery.
  • Ejection fraction less than 35%.
  • Refusal of the patient.
  • Known hypersensitivity to LA.
  • Chronic opioid use or chronic pain patient.
  • Psychiatric problems or communication difficulties.
  • Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7)
  • Renal insufficiency (defined as a glomerular filtration rate < 44 ml/min).
  • Obstructive sleep apnea syndrome.
  • Coexisting hematologic disorders.
  • Pregnancy or breastfeeding.

结局指标

主要结局

The primary outcome will be total morphine consumption

时间窗: 24 hours

Total morphine consumption within 24 hours according Visual Analogue Score (VAS) for sternal pain both during rest and with cough (ranging from 0 indicating no pain to 10 indicating extreme pain). A score ≤ 3 was considered acceptable for pain relief. Supplementary rescue analgesia was administered in the form of morphine IV 0.05 mg/kg (at VAS ≥ 4).

次要结局

  • The secondary outcomes will be the first analgesic request time(24 hours)

研究者

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

Mariana Soliman

Lecturer of anaesthesia, surgical intensive care and pain managment

Beni-Suef University

研究点 (1)

Loading locations...

相似试验