Transversus Thoracic Plane Block for Perioperative Analgesia in Cardiac Surgery: a Randomized Controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- postoperative pain score
研究概览
简要总结
The goal of this clinical trial is to learn if perioperative Transversus Thoracic Plane Block (TTPB) decrease perioperative pain after cardiac surgery. The main questions it aims to answer are:
- does Transversus Thoracic Plane Block decrease perioperative pain after cardiac surgery more than the standard analgesic treatment?
- Are the results different if the investigators perform Transversus Thoracic Plane Block before surgery or at the end of surgery?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All patients scheduled for cardiac surgery via sternotomy under cardiopulmonary bypass
排除标准
- •Previous cardiac surgery
- •Urgent surgery
- •Pregnant women
- •Allergy to local anesthetics
- •Opioid dependence
- •Low ejection fraction < 30%
- •Presence or onset of cognitive or neurological disorders preventing pain assessment
- •Infection at injection sites
- •Coagulopathy
- •Patients on dual antiplatelet therapy
- •Renal insufficiency with Glomerular filtration rate (GFR) < 30 mL/min
- •History of thoracic radiotherapy
- •History of mastectomy
研究组 & 干预措施
Placebo
This group receives standard analgesic treatment and no Transversus Thoracic Plane Block is performed
Transversus Thoracic Plane Block pre
This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed before surgery
干预措施: Transversus Thoracic Plane Block (Procedure)
Transversus Thoracic Plane Block post
This group receives standard analgesic treatment and Transversus Thoracic Plane Block is performed at the end of surgery
干预措施: Transversus Thoracic Plane Block (Procedure)
结局指标
主要结局
postoperative pain score
时间窗: First 24h postoperatively
The primary outcome is Postoperative Pain Score: Numeric rating scale (NRS) ratings will be assessed at T1 (= upon patient awakening), T2 (= 12 hours postoperatively), T3 (= 24 hours postoperatively) as well as during various painful moments (coughing, drain removal, mobilization). Numeric rating scale (NRS) is a unidimensional measure of pain intensity. It consists of the patient evaluating his pain out of a series of numbers ranging from 0 to 10, where the 2 respective endpoints are "0 = no pain" and "10 = worst possible pain."
次要结局
- Incidence of postoperative pneumonia and pneumothorax in cardiac intensive care unit(First 24h postoperatively)
- Perioperative opioid requirement(First 24h postoperatively)
- Time to first opioid administration(First 24h postoperatively)
- Length of stay at cardiac intensive care unit and hospital stay(3 months postoperatively)
- Time to extubation(First 24h postoperatively)
- Patient satisfaction at 24 hours post surgery(First 24h postoperatively)
研究者
Joanna Tohme
Medical Doctor, Principal investigator
Saint-Joseph University